2015 Liver Cancer News
Lixte Bio License Deal in Asia for Lead Cancer Compound for Liver Cancer
The company’s LB-100 inhibits an enzyme that helps repair cancer cells damaged by chemotherapy or radiation. The company granted an exclusive license to administer LB-100 in Asia to Taipei Medical University in a clinical trial to determine the efficacy of the therapy against Hepatocellular Carcinoma.
Hepatitis Carriers Unaware: Group
It is estimated 1 million Taiwanese citizens are carriers of the hepatitis B antigen, according to the Taiwan Association for the Study of the Liver, and only 170,000 have sought treatment. Chronic HBV infection screening showed that among people found to be HBV carriers, only 43% were aware of this fact. A study of 14,395 chronic hepatitis patients from 2000 – 2011 found that uninterrupted treatment can reduce liver disease and cirrhosis by 22%, liver cancer by 14%, and death from liver cancer by 24%, stated Chien Rong-nan, head of the association and deputy superintendent at Keelung Chang Gung Medical Hospital.
METIV-HCC Tivantinib Phase 3 Trial Completes Enrollment for HCC
The METIV-HCC trial is a collaboration between Arqule, Inc. and Daiichi Sankyo, Inc., that will include at least 300 patients with HCC and MET-high tumors. The patients will be given tivantinib, a selective inhibitor of the c-MET receptor, with overall survival as the primary endpoint. “It has been very encouraging to see a growing body of evidence supporting the phase 3 clinical evaluation of tivantinib in MET-high populations through a recent presentation at the International Liver Cancer Association conference,” stated Brian Schwartz, MD, head of R&D and chief medical officer at Arqule, Inc.
SBI1997 is an autologous dendritic cell immunotherapy for HCC that assists each patient’s immune system to identify tumor-specific antigens and destroy cancerous cells after surgery. The AUDIT (Adjuvant Use Dendritic Cell Immunotherapy) trial will determine the efficacy of SBI1997 in increasing recurrence-free survival and overall survival in HCC patients. The AUDIT trial is expected to launch in the New York metropolitan area in the first or second quarter of 2016.
At Shanghai First People’s Hospital between January 2001 and December 2011, 290 HCC patients who underwent liver transplantation were retrospectively analyzed for risk factors for survival. It was discovered that younger patients at the center experienced more aggressive tumors with a greater risk of recurrence while older patients had longer recurrence-free survival and longer overall survival. “Our single center experience suggests that younger patients should be assessed more rigorously before LT while aged patients should be actively considered for LT after appropriate selection,” stated the authors.
BRIEF-Immunicum: Approval to Extend Phase I/II Study in Liver Cancer
“Immunicum has received approval to extend the phase I/II study in liver by up to six patients to be treated with INTUVAX in combination with first-line treatments.”
Celsion (CLSN) Announces CFDA Approval for Ongoing Phase III OPTIMA Study
Celsion has received Clinical Trial Approval (CTA) from the China Food and Drug Administration to conduct the ongoing phase III OPTIMA Study at approved sites in China. OPTIMA is a global, double-blind, placebo-controlled trial to determine the efficacy of doxorubicin, (Thermodox ®), combined with radiofrequency ablation (RFA) to treat Hepatocellular Carcinoma. “The OPTIMA Study is the only global Phase III clinical trial being conducted in HCC, and the China market is an important element of our global development strategy for Thermodox ®, representing approximately 50% of the 850,000 new cases of primary liver cancer diagnosed each year,” stated Michael H. Tardugno, Celsion CEO, president and chairman.
Hypofractionated Proton Therapy Demonstrates Local Control
Massachusetts General Hospital researchers conducted a single-arm, phase 2, multi-institutional study of 83 patients with unresectable HCC or ICC (intrahepatic cholangiocarcinoma). Hypofractionated proton therapy resulted in high local control (arrest of cancer growth at the site of origin) among survivors after two years in 94.8% of HCC patients.
Drug-Filled Nano Bubbles Fight Liver Cancer
Academic and industry have researchers have collaborated to create a “triple attack” method that combines chemotherapy, thermal ablation and hyperthermia to target HCC. Bexarotene (Targretin), a drug used to fight T-cell lymphomas, was re-engineered into self-forming nanobubbles that were filled with Targretin. The nanobubbles were delivered via flexible catheter directly into the tumor where ultrasound ablation therapy was used to pop the bubbles and release the agent. Called Trimodal Therapy, the researchers hope the highly targeted and minimally invasive approach can be tested on humans in the near future.
RDA, SBRT Both Good Options for Unresectable Hepatocellular Carcinoma
University of Michigan researchers conducted a retrospective trial that examined the results of 161 non-metastatic HCC patients who underwent radiofrequency ablation (RFA) and 63 patients who underwent stereotactic body radiotherapy (SBRT). The outcomes were similar: 1-year freedom from local progression (FFLP) with RFA was 83.6% and with SBRT was 97.4%; 2-year FFLP was 80.2% and 83.8%, respectively. “It would be incorrect to suggest that all unresectable HCCs be treated with SBRT. RFA provides excellent local control for tumors smaller than 2cm, but has difficulty controlling lesions larger than 3cm,” wrote the authors.
NAFLD-Associated HCC prevalent in the US
Data from the Surveillance, Epidemiology, and End Results (SEER) database, as well as Medicare claims filed from 2004 – 2009 were analyzed by Inova Health System researchers who found that HCC caused by non-alcoholic fatty liver disease (NAFLD) is on the rise. In the study group of HCC patients, 54.9% were related to HCV, 16.4% to alcoholic fatty liver disease (ALD), 14.1% to NAFLD and 9.5% to HBV. In males with NAFLD, there was a threefold increase in the odds of developing HCC. The researchers concluded, “Our data showed that patients with NAFLD-related HCC suffer a worst prognosis than other causes of HCC.”
Clinical Impact of Effective HCC DAAs: Referrals For Liver Transplant Drop After Their Introduction
Since the introduction of direct-acting antivirals (DAA) for the treatment of hepatitis C virus there has been a 23% drop in HCV-related referrals for liver transplants, according to two U.S. studies presented at the 2015 AASLD meeting in San Francisco. In addition, the number of transplant referrals for HCV-related cases that had not yet advanced to non-hepatocellular carcinoma dropped by 33%. “HCV is the leading cause of referral for transplantation in the US; approximately 45% of people who receive liver transplants in the United States have hepatitis C.
Liver’s Cannabinoid Receptors Could Be Targeted To Combat Liver Cancer In Some Patients
The human body has its own marijauna-like substances, called endocannabinoids, which are known to assist in the biosynthesis of fatty acids in the liver. This biosynthesis activates the cannabinoid type 1 receptor (CB1) which in turn helps liver cancer cells proliferate. Researchers suggest that blocking the CB1 receptor could be an efficacious treatment for HCC.
Does Antiplatelet Therapy Cut Liver Cancer Risk in Patients With Hep B?
Platelets incite HCC virus-specific cells in the liver, thereby damaging liver tissue, but hepatitis B mouse models have shown that the use of anti-platelet drugs can prevent the creation of those HCC cells. A retrospective analysis was conducted by researchers of 3,479 patients with chronic hepatitis B. In Group 1, 2,566 patients were treated with anti-platelet drugs and in Group 2, 592 patients were treated with aspirin and/or clopidogrel. “Anti-platelet therapy was associated with a significantly lower incidence of hepatocellular carcinoma than [seen] in those not treated with anti-platelet therapy,” stated Minjong Lee, MD., of Seoul National University College of Medicine. “Antiplatelet therapy might have significant effects on HCC prevention according to the severity of the hepatic fibrosis.”
Antivirals Benefit Hep B Patients With Normal Or Elevated ALT
Non-cirrhotic chronic hepatitis B (CHB) patients with minimally elevated alanine aminotransferase (ALT) who were treated with antiviral therapy had a substantially reduced risk of developing hepatocellular carcinoma. Untreated CHB patients with ALT less that 2 times the upper limit of normal (ULN) had a higher likelihood of HCC than treated patients. “Non-cirrhotic with ALT less than 2 times ULN who are older than 40 may benefit from antiviral therapy,” concluded the research team.
Liver Cancer Risk Will Remain Elevated For People With Cirrhosis Cured Of Hepatitis C
For Americans with cirrhosis of the liver, curing hepatitis C translates into a two-thirds reduction in the likelihood of developing liver cancer at the time of the cure. However, due to the damage caused by cirrhosis and hepatitis C many will remain at risk for hepatocellular carcinoma down the road. “Direct-acting antivirals will reduce HCC risk, and the way they will do that is by treating patients before end-stage, cirrhosis, before getting cirrhotic,” said Gyongi Szabo, President of the American Association for the Study of Liver Disease (AASLD). “If we treat patients who already have cirrhosis, we can make the liver a little better, but the risk of liver cancer will remain.”
Mirna Therapeutics Reports Third Quarter Financial Results and Recent Highlights
The company’s drug candidate, MRX34, is in a Phase I clinical trial in the U.S and Korea for hepatocellular carcinoma and other cancers. One patient with primary liver cancer metastatic to the lung showed a confirmed, partial response to the treatment. Mirna will finish does-escalation of MRX34 this year and enroll more patients in the HCC and other tumor-specific cohorts by the end of 2016.
GenSpera Provides Update on Clinical Development Programs
G-202 is engineered from thapsigargin, a cytotoxic agent developed from the Thapsia garganica plant. It was created by pairing a prostate-specific membrane antigen to a non-toxic form of thapsigargin that would be activated by a specific protein found only at the tumor site. Normal cells are left unharmed while a higher concentration of the active agent can be delivered directly to the tumor. The company is preparing a Phase IIa dose-escalation trial to evaluate safety, tolerability and efficacy in HCC patients. Recently presented data showed that 63% of patients treated with mipsigargin experienced disease stabilization within two months.
Pexa-Vec is viral therapy designed to target and destroy cancer cells through the breakdown of cancer cell replication, the reduction of blood flow to the tumors and by stimulating the body’s immune system to fight the cancer cells. PHOCUS, the name of the Phase III trial will treat HCC patients with Pexa-Vec followed by Sorafenib, as a first-line treatment starting at the end of this year. SillaJen plans to enroll 600 patients in North America, Europe and Asia.
Blueprint Medicines Highlights Advances in Preclinical Discovery Efforts
The company presented preclinical data for BLU-554 in the treatment of advanced hepatocellular carcinoma. In a Phase I, dose-escalation clinical trial for the drug, BLU-554 showed anti-tumor activity and the company is currently enrolling more patients.
Researchers Create Index to Aid Liver Cancer Risk Analysis
Taiwanese researchers performed a follow-up study of 1,095 Hepatitis C patients over 15 years and highlighted 5 contributing risk factors for liver cancer development: age, liver function index, virus genotype, virus load and degree of liver fibrosis. The highest risk of contracting liver cancer was associated with degree of liver fibrosis. The team said that the index model had a 70% precision rate.
HIV Does Not Worsen Outcomes of Liver Transplant in HCC
University of Barcelona researchers studied the outcomes of HIV-infected patients undergoing liver transplant for HCC and found that the autoimmune disease had no effect on outcomes. Patient survival at one, three and five years for HIV-infected patients was almost identical to the rate of survival for non-infected patients.
EPA Approves Use of Virus for Liver Cancer Treatment Trial
Pexa-Vec is a weakened virus based on the smallpox vaccine that, when injected directly into the HCC tumor, grows rapidly inside the cancer cells and kills them. The application for release of Pexa-Vec is for a Phase III clinical trial of the drug in New Zealand to treat hepatocellular carcinoma patients. “These trials will assess the effectiveness and side effects of the virus and compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.”
Simple Blood Test Measures Risk of Liver Cancer
The GlycoCirrhoTest (GCT), a blood test for cirrhosis of the liver, has been found to be an effective predictor of HCC. The test revealed useful values in 132 cirrhosis patients who had a medical follow-up for up to four years. This sample of patients means that clinicians can divide patients into a high and low-risk group for developing HCC. “Further research is required before this test can be applied everywhere, but our research results are promising,” said Dr. Xavier Verheist, hepatologist and researcher at UZ Ghent. “The use of the GlycoCirrhoTest in patients with cirrhosis of the liver makes it possible to create a customized follow-up schedule for each patient. On the basis of the risk measured, they could receive intensive or less intensive screening.”
Sartans May Improve Survival, Time to Recurrence in Liver Cancer
Using data from 153 HCC patients following treatment with radiofrequency ablation, Italian researchers found that sartans, a class of drugs that help alleviate high blood pressure, showed marked improvement in patient outcomes. “Sartans significantly improved overall survival and time to recurrence after radiofrequency ablation in hepatocellular carcinoma,” wrote the authors.
After Patient Deaths, FDA Warns About Liver Damage Risk of Hepatitis C Medications
The FDA issued warnings for the hepatitis C medications Viekira Pak and Technivie after reports of patients who either died or had to undergo liver transplantation after being treated with the drugs. The drug maker AbbVie will be required by the FDA to add new warnings to the safety labels of the drugs for patients who have HCV-linked advanced liver disease. The drugs are, essentially, a cure for hepatitis C. The company noted in a press release: “...Most patients with these severe outcomes had evidence of advanced cirrhosis prior to initiating therapy.”
Diabetes, Hypertension Raise Risk for Liver Cancer
While previous studies have suggested a link between diabetes and hepatocellular carcinoma, Penn State researchers conducted a retrospective study of 17, 446 HCC patients to determine if hypertension and hyperlipidemia were also causes. Hyperlipidemia is an excess of lipids in the bloodstream that can cause high cholesterol. Analysis found that patients with a combination of diabetes, hypertension and hepatitis C had four times the likelihood of developing HCC. Patients with diabetes, hyperlipidemia and hepatitis C were also at a higher risk. John Saltzman, MD, Brigham and Women’s Hospital in Boston, spokesperson for the study said: “Diabetes and hypertension were predictive of hepatocellular carcinoma, but I’m not sure I understand the mechanism of hypertension [in the disease.] The question is whether screening patients with diabetes and hypertension for HCC is cost-effective.
Monitoring Circulating Tumor DNA Could Improve Outcomes in HCC
Hiroshima University researchers have found that amounts of circulating tumor DNA in a patient’s serum was linked with larger HCC tumor size and a higher risk of recurring tumors within 2 years. “We uncovered that circulating tumor DNA levels accurately reflect cancer progression and therapy effects on hepatocellular carcinoma,” stated Atushi Ono, Ph.D., lead author of the study. “With further research, the identification of genome profiles through circulating tumor DNA analysis may guide individualized management of hepatocellular carcinoma.”
The designation for ENMD-2076 gives CASI Pharmaceuticals 10-years market exclusivity in the EU pending market authorization there. ENMD-2076 received Orphan Drug designation for the treatment of HCC by the U.S. FDA in 2014.
Second-Line Treatments for Advanced Hepatocellular Carcinoma
The search for efficacious second-line treatments for advanced HCC has been difficult, with candidate agents everolimus, brivanib and ramucirumab all failing to meet primary endpoints in their respective trials. (However, HCC patients with elevated alpha-fetoprotein levels had better survival with ramucirumab.) Tivantinib, cabozantinib and regorafenib have shown promise as second-line treatments. “Further understanding of the complex interaction between antiangiogenic, antimetastatic and immunotherapeutic agents is warranted to facilitate progress in the systemic treatment of advanced HCC,” stated the study authors.
Can-Fite’s CF102 Granted Orphan Drug Designation by EMA for Treatment of Hepatocellular Carcinoma
CF102 is a small, orally bioavailable drug that has shown strong anti-tumor effects and has induced death of liver cancer cells. The European Medicines Agency’s (EMA) announcement gives CF102 market exclusivity for 10 years in 28 European Union Member States. Can-Fite is conducting a Phase II study with CF102 for advanced HCC patients in the U.S., Europe and Israel and expects to have full enrollment midway through 2016.
Liver Cancer – Pipeline Review, H1 2015
“This report provides comprehensive information on the therapeutic development for Liver Cancer, complete with comparative analysis at various stages, therapeutics assessment by drug target... and also reviews key players involved in the therapeutic development for Liver Cancer and special features on late-stage and discontinued projects.”
National Cancer Institute Posts Benefits of Marijuana on Federal Government Website
In a laboratory study, delta-9-THC was shown to damage or kill HCC cells in a laboratory study. NCI is the federal government’s primary agency for cancer research and training and recently updated its website with the antitumor activity of marijuana on HCC, as well as other cancers.
Novel Immunotherapies on the Horizon in HCC
Immunotherapies, as a second-line treatment for HCC, have been explored for decades, but have shown little promise. Recent knowledge of HCC-specific tumor-associated antigens (TAA) and the progression of immune checkpoint blockade therapy, however, are changing that outlook. Research into multiple TAAs is in the early stages, but it gives hope to patients with advanced HCC.
No Survival Advantage Displayed With Transarterial Chemoembolization
A retrospective review of 183 patients with advanced HCC and main portal vein thrombosis (MPVTT) who were treated with transarterial chemoembolization (TACE) in combination with sorafenib showed no improvement in survival compared to sorafenib alone. Median time to progression for the combined therapy and monotherapy was 3 months; median overall survival was 7 months for combined therapy versus 6 months for the monotherapy.
TRL Helps Increase Liver Awareness by Supporting Liver Research in October
Triangle Research Labs, in honor of National Liver Cancer Awareness Month, is donating a portion of its October profits to support the continuation of liver cancer research and hepatology practices. The American Liver Foundation states that 30 million Americans have one or more types of liver disease and TRL wants to spotlight that fact amidst the massive public presence of Breast Cancer Awareness Month, also in October. “TRL is dedicated to furthering liver research in a variety of ways, whether it is by providing the highest quality hepatocytes to scientists around the world, collaborating with researchers in different disease and investigation areas, or directly donating to causes supporting these efforts,” stated TRL Executive Director Matt Sherman.
European DSMB Recommends Continuation of ONXEO Livatag ReLive Study in HCC
The international Phase III trial ReLive is assessing Livatag’s efficacy on survival in 400 advanced HCC patients following treatment after failure or intolerance to Sorafenib. The delivery of Livatag to HCC cells via nanoparticles short-circuits the body’s drug resistance by masking the anticancer agent. The European Data Safety Monitoring Board (DSMB) has given the company the green light to continue the study without modification.
Nintedanib Shows Promise for Treatment of HCC
In a Phase 1/2 study of 30 Asian and Caucasian HCC patients, nintedanib was effective and showed an acceptable level of safety as a treatment. Side effects were nausea, diarrhea, decreased appetite and vomiting, all similar to the side effects of sorafenib. Researchers summed up,” Nintedanib has a manageable safety profile with no unexpected adverse events and promising efficacy signals in prior [sorafenib] treated patients that warrants further study.”
The company’s BLU-554 is in a Phase I clinical trial for patients with advanced HCC and cholangiocarcinoma. In preclinical models, the drug has shown definitive anti-tumor activity and orphan drug status gives the company market exclusivity for seven years if the drug is approved. “We believe BLU-554 represents a promising new approach for molecularly targeted therapy in HCC,” stated Jeffrey Albers, CEO of Blueprint Medicines. “We are pleased that we continue to make progress toward our goal of delivering a highly targeted medicine to improve the lives of HCC patients.”
Radiofrequency Ablation Dwell Time Significantly Impacts Survival in HCC
In Phase III of the HEAT study, 285 HCC patients were treated with lyso-thermosensitive liposomal doxorubicin (LTLD; Thermodox) with optimized (45 minutes dwell time) radiofrequency ablation (RFA). Median overall survival (OS) was 79 months compared to 53.57 months with RFA as a stand-alone treatment. “Results from the HEAT study, one of the largest clinical trials ever conducted in primary liver cancer, reinforce the potential for Thermodox in combination with an optimized RFA regimen as a curative treatment for this deadly cancer,” stated Riccardo Lencioni, MD., professor and director of Diagnostic Imaging and Intervention at Pisa University School of Medicine in Pisa, Italy.
Routine Testing May Predict HCC Risk
Chinese researchers analyzed almost half a million of their citizens to develop a 48-point blood and urine test that can predict early liver cancer risk in patients 95% of the time. Data points analyzed include demographic data, complete blood count (CBC), complete metabolic panel (CMP) and urinalysis. “The research would provide an effective, convenient and economical method in early liver cancer prevention and help both patients and doctors monitor early liver cancer risk,” stated the research team.
Routine Ultrasonography Improves Survival in Viral Hepatitis with HCC25 Sept 2015In a retrospective cohort study of adult patients with viral hepatitis diagnosed with HCC, researchers found that regularly scheduled ultrasounds improved survival and reduced risk of mortality. For HBV patients who received regular surveillance, median survival after HCC diagnosis was 27 months versus 21.4 months for those who received irregular surveillance versus 15.7 months for those who received no surveillance. “Our findings suggest that routine ultrasonography in patients with viral hepatitis is associated with improved survival and reduced mortality risk in a population-based setting. The data emphasizes the importance of surveillance for timely intervention in HCC-diagnosed patients,” stated the Canadian researchers.
Surefire Medical Launches Advanced Precision Direct-To-Tumor Infusion System at CIRSE
The Precision catheter will deliver drug eluting and yttrium-90 microspheres to primary liver cancers that many times contain regions of high pressure and no blood flow, barriers to conventional drug delivery. A recent clinical trial showed that the Surefire infusion system demonstrated a 90% increase in drug targeting to tumors. “The drug delivery system matters far more than previously thought,” stated Surefire Medical’s President and CEO, James E. Chomas.
Exelixis, Inc. (NASDAQ:EXEL) Announced That Cotellic (cobimetinib) Gained Approval in Switzerland
Cotellic, an approved treatment for aggressive, metastatic medullary thyroid cancer, is being evaluated by Exelixis for the treatment of hepatocellular carcinoma.
For Hepatocellular Carcinoma, Axitinib May Improve Survival, Time to Progression
Axitinib, a vascular endothelial growth factor receptor inhibitor, showed longer progression-free survival time and better clinical benefit than placebo in a phase 2 study for treatment of advanced HCC. The study showed no significant improvement in overall survival between axitinib and the placebo.
FDA Fast Tracks Can-Fite’s CF-102 for Liver Cancer; Shares Up 39% Premarket
The company is currently in phase II of a study of CF-102 as a second-line treatment for HCC patients. CF-102 has induced cell death in liver cells and shows promise in combatting the most common form of liver cancer.
Research and Markets: Liver Cancer—Pipeline Review H1 2015
A comprehensive, global review of the treatments, pharmaceutical companies involved and assessments by drug target for liver cancer.
Potential New Therapeutic Approach Found For Liver Cell Cancer
Fibroblast Growth Factor Receptors (FGFR) are found on the surface of cells and can control organ and tissue growth, but when misregulated may play a role in the progression of HCC. Regarding the study, “The results showed that, in 50% of the HCC cases, there were noticeably raised levels of at least one of the two FGFR3 isoforms on the surface of the tumour cells,” stated Jakob Paur, lead author of this paper and member of the Comprehensive Cancer Center (CCC) of MedUni Vienna. “The greater the concentration of the receptor in the tumour tissue, the larger the primary tumour and the greater the probability of finding recurrences.” The authors speculate that blocking the FGFR3 could become an effective treatment for Hepatocellular Carcinoma.
MicroThermX® implements pinpoint microwave energy to burn and destroy soft tissue of the liver, among other organs. MicroThermX® was used on HCC patients with large tumors and 80% of diseased tissue was burned away. The treatment was deemed safe and efficacious.
Sorafenib Not Effective After Resection, Ablation for Hepatocellular Carcinoma
Researchers conducted a double-blind study to learn the effectiveness of sorafenib as an adjuvant therapy versus a placebo with 1,114 HCC patients who had undergone resection or ablation. Median recurrence survival for patients was 33.3 months in the sorafenib group and 33.7 months in the placebo gro
Drug-Eluting Chemoembolization No Better For Hepatocellular Carcinoma
Italian researchers found that for unresectable HCC patients the objective response rate of conventional chemoembolization was 85.3% versus 74.8% for drug-eluting beads chemoembolization. Median times to progression were 17 and 11 months and median survival was 39 and 32 months. “ In a large series of Western Hepatocellular Carcinoma patients, drug-eluting beads chemoembolization... did not seem to improve survival in comparison to conventional chemoembolization, which in turn provided better tumor responses and time to progression,” stated the authors of the study.
New DNA Testing for Liver Cancer Could Improve Survival
Whole-genome sequencing was performed on 46 HCC patients who underwent resection and who had serum samples taken pre-and post surgery. The researchers compared the DNA from normal tissue to DNA from the tumor in the same patient in the hope of finding a more effective treatment for HCC. “We uncovered that circulating tumor DNA levels accurately reflect cancer progression and therapy effects on Hepatocellular Carcinoma,” stated lead study author, Atushi Ono. “With further research, the identification of genome profiles through circulating tumor DNA analysis may guide individualized management of Hepatocellular Carcinoma.”
Discontinuing Nexavar Leads To Increased Survival In HCC
Italian researchers analyzed data from 260 HCC patients coinfected with cirrhosis who were referred to medical centers in Italy to receive care after permanent termination of Nexavar treatment. The endpoint of the study was patient survival after ending treatment. “Discontinuation due to adverse effects in the absence of macrovascular invasion, extrahepatic metastases and deteriorated PS (performance status) predicts the best PSS (post-sorafenib survival) in compensated patients, thereby setting the stage for both improved patient counseling and selection for second-line therapy,” stated the researchers.
The company made presentations by three leading experts regarding the Phase III OPTIMA Study. The treatment combines Thermodox®, the company’s heat-activated liposomal encapsulation of doxorubicin, with optimized radio frequency ablation (RFA) to treat primary liver cancer.
The MET gene, at healthy levels, can be present to support normal cell function, but can be activated continuously and inappropriately in cancer cells. ArQule’s phase 2 study administered tivantinib to 107 HCC patients who progressed or were unable to tolerate one previous systemic therapy and found that MET-status was the best predictor of drug efficacy. “The biomarker data from this study demonstrates that patients with MET-high tumors are more likely to benefit from tivantinib therapy,” said Dr. Brian Schwartz, ArQule’s head of research and development.
University of Hawaii Cancer Center Researcher Awarded $2.7M For Liver Cancer Study
Dr. Wei Jia Ha, Director of Shared Resources at the Cancer Center is studying gut bacteria and how it can lead to liver cancer and to see if adjusting the breakdown of bile acid can protect the liver. “We have the highest rate of liver cancer in the nation in Hawaii,” said Ha. “The exact reason we still don’t know, but a few factors you might consider are our unique ethnic population here and a high incidence of viral infections that usually lead to a number of liver conditions and progress to cirrhosis and cancer.” The five-year study commenced on August 1.
From November 2011 to January 2014, researchers studied 109 newly-diagnosed HCC patients with low level HBV DNA who underwent at least two TACE (transarterial chemoembolization) procedures and were followed up to check for reactivation. The team concluded that HCC patients with low serum HBV DNA levels were still at risk for HBV reactivation after TACE.
The liver cancer market is comprised of 70 products, mostly generic chemotherapy, which is not normally used. This report on standard and innovative liver cancer therapies presents 238 products in the active stage of development.
Exclusive: Kiwi Discovery Could Help Save Lives of 400 Million People with Hepatitis B
Researchers may now be able to determine which chronic hepatitis B patients will develop liver cancer by way of a key DNA marker in the blood. The team analyzed blood serum from a study 30 years ago, followed up with survivors and can now identify exactly which patients will develop liver cancer and cirrhosis by examining HBV levels with a blood test. “If we’re able to say at an early stage that a particular person’s at risk for liver cancer then we can put them into more intensive follow-up so we can pick up the liver cancer at a very early stage,” commented Professor Ed Gane, hepatologist at Auckland City Hospital.
An oral presentation of Blueprint’s BLU-554, a molecularly targeted HCC therapy, took place at the ILCA in Paris September 4-6, 2015. Data on the therapy’s anti-tumor activity on preclinical models of HCC was presented.
Regen Developing New Gene Procedure for Targeting Liver Cancer Cells
Regen has developed a therapy that delivers the gene silencing nucleic acid RGBP-248 faster to tumors and cancer cells in order to treat unresectable liver cancer. The local delivery system will lower the toxicity of the treatment in the body while delivering more of the therapeutic agent to the tumor. “In contrast to chemotherapy, which does not target cancer stem cells, there is evidence suggesting that gene silencing... does kill cancer stem cells. By killing cancer stem cells we believe that our new approach in development will lead to improved efficacy of the clinically used transcatheter arterial chemoembolization procedure,” stated David Koos, Ph.D., chairman and CEO of Regen BioPharma.
Obesity In Early Adulthood Increases Risk For HCC
In a case-controlled study that examined clinical and epidemiological data with obesity data, clinicians studied the integrated effects of obesity, HCC risk factors and age. Patients who were obese ever in their lifetimes had an HCC incidence rate of 38.4% versus a rate of 30.6% of the controls. The researchers wrote,” A prior history of obesity in the mid-20s, mid-30s and mid-40s was associated significantly with an increases HCC risk in the whole study population and in the absence of major HCC risk factors.”
Arbutus Shares Rise As Patient Dosing Begins In Hepatocellular Carcinoma Clinical Study
Already focused on a cure for chronic hepatitis B infection, Arbutus started a phase IIa clinical study treating HCC patients with TKM-PLK1. The purpose of the study is safety and efficacy and the endpoint is tumor response rate. The trial has enrolled 20 patients in Canada, the U.S. and Asia. “HCC is one of the most common cancers in the world, primarily caused by an underlying chronic HBV infection. The goal of this study is to further evaluate the anti-tumor efficacy of TKM-PLK1 in treating HCC patients,” stated Dr. Mark J. Murray, Arbutus’ president and CEO.
Immunicum Updates Safety And Survival Data In Phase I/II Liver Cancer Study With INTUVAX
In the ongoing phase I/II study (IM-102), nine patients with Hepatocellular Carcinoma have been treated with Intuvax, with no serious side effects thus far. Out of seven patients treated with all three planned doses, four have surpassed expected median overall survival and two have yet to reach that endpoint. Two patients had a rapid progression of HCC and died before their first vaccination. Immunicum’s CEO, Jamal El-Mosieh, said, “We are pleased that the survival data continues to progress well... A status update will be provided at the end of the year where we hope to announce more concrete plans on how we intend to pursue the continuation of the project.”
Top Takeaways From ASCO: Gastrointestinal Cancer
The PD-1 inhibitor nivolumab had a 23% response rate in HCC patients in a small, non-randomized study by USC researchers. Complete response to the drug was between 14 and 17 months; partial response between 1 and 8 months; with stable disease between 1.5 and 17 months and a 72% overall survival rate. “The findings move the field forward in treating a disease that is incredibly desperate and doesn’t have many standards. We have to wait for more mature data from larger randomized trials,” stated the group leader.
HIV Providers Less Likely Than Hepatologists To Screen For HCC
Researchers in North Carolina conducted a retrospective analysis of 114 patients co-infected with HIV and HBV and 225 patients with HBV only and found that HIV caregivers screened for HCC less than hepatologists. Over 2 years, only 36% of patients visiting HIV clinics were screened versus 81.8% of patients visiting hepatology specialists. “Given the 8-fold increased risk of death related to liver disease in HIV/HBV coinfection and a 7-fold increased risk for HCC compared to HBV monoinfection, this study and published findings strongly indicate that improving HCC screening practices should be a priority for HIV clinicians caring for HIV/HBV coinfected patients,” wrote Bevin Hearn, MD., Carolinas HealthCare System, Charlotte, North Carolina.
Possible Test For Liver Cancer Using Technology For Analyzing Rocks And Minerals
It is common knowledge that copper regulation in the body can be affected by the presence of cancer. A team of geochemists and clinicians have found the level of copper in HCC patients versus controls is different and the hope is to use this knowledge to find a blood test for the deadly cancer. “At the moment the results are preliminary, but if we can confirm the validity of an isotopic test for HCC, this might have a significant impact on patients who have chronic liver disease, who risk developing liver cancer,” said group leader and geochemist Vincent Balter.
Liver Cancer—Pipeline Review Report H1 2015
A comprehensive overview of the therapeutic pipeline for liver cancer with comparative analysis at various stages, drug assessment and key players involved in development in treatments.
Celsion Reports Updated Results From HEAT Study Of ThermoDox In Patients With Primary Liver Cancer
The HEAT Study treats 701 HCC patients with a combination of ThermoDox, a heat-activated liposomal encapsulation of doxorubicin and radiofrequency ablation (RFA). Results released on July 15, 2015 showed that 41% of patients given the treatment had a 58% improvement in overall survival (OS) versus RFA alone. Median overall survival was 79 months for the combined treatment versus 53.6 months for the RFA-only group. “These results from the HEAT Study reinforce the potential for ThermoDox® in combination with an optimized RFA regimen to serve as an effective treatment option that could significantly improve overall survival in primary liver cancer patients,” stated Dr. Nicholas Borys, senior VP and chief medical officer of Celsion.
Cyramza Liver Cancer Trial Fails OS Endpoint: Subgroup Data To Form Basis For New Study
Cyramza, (ramucirumab), a second line treatment for Hepatocellular Carcinoma, failed to meet its primary endpoint of overall survival in a phase III trial. Due to success at secondary endpoints in some patient subgroups, Eli Lilly hopes to start a new phase III trial for the drug.
More Aggressive Therapy Options Are On The Table For Elderly Patients With HCC
Investigators at First Affiliated Hospital of Nanjing Medical University in China conducted a retrospective, single-center study on the treatment of advanced HCC patients with systemic sorafenib therapy combined with transarterial chemoembolization (TACE). They found that patients above/below aged 70 had similar outcomes and tolerability for treatment.
Adjuvant and Combination Therapies For HCC
VIDEO: A panel of doctors and clinicians discuss combination therapies for the treatment of Hepatocellular Carcinoma.
Not Resecting Ideal Candidates Ups Mortality In Liver Cancer
Researchers at Lenox Hill Hospital have found that when ideal HCC patients do not undergo liver resection, their risk of death increases. The team came to this conclusion after reviewing guidelines for liver resection as primary treatment for 8,656 HCC patients. “The study suggests that selection criteria for resection may be modestly expanded without compromising outcomes, and that some non-ideal candidates may still potentially benefit from resection over other treatment modalities,” the authors wrote.
Study Says 600,000 Afflicted By Liver Cancer Every Year
The most recent Global Burden of Cancer Study states that 600,000 new cases of liver cancer are reported annually in the Asia Pacific region, an increase of two-thirds from 1990 levels. The study goes on to say that chronic hepatitis B and C cause 78% of these cases. “People have been diagnosed (with) hepatitis, but are not followed up with adequate care, because of gaps in the system for hepatitis management. Stigma and misinformation about hepatitis abounds,” said Professor Ding-Shinn Chen, co-chairperson of the Coalition to Eradicate Viral Hepatitis in the Asia Pacific (CEVHAP). The World Health Organization (WHO) has taken steps to help governments with this goal and has drafted a strategy in which hepatitis eradication targets are proposed.
Hepatitis Causes Over 1.4M Deaths Yearly, 80% of Liver Cancer, Says WHO
To mark World Hepatitis Day (WHD) on June 28, 2015, the WHO highlighted the urgent need for governments worldwide to prevent viral hepatitis infection and adequately treat those infected. Among other recommendations, the WHO urges people to know their risks; demand safe injections; get vaccinated; get tested and seek treatment. The WHO’s flagship event this year took place in Egypt, where it is estimated that 10% of the population between the ages of 15 and 59 have chronic HCV, one of the highest rates in the world. The government has opened 32 treatments centers and the WHO is helping the country develop national blood safety standards.
Researchers Find New Method To Halt The Advance Of Liver Cancer
The lymphotoxin-beta receptor is known to control the development of lymphoid organs, which bolster the body’s immune system against pathogens. Researchers have discovered that blocking this receptor reduces the progression of liver cancer. “For some time we have known about the interconnection between the receptor, inflammation including inflammation caused by hepatitis and liver cancer. Now, we have demonstrated how the receptor’s signals create an environment that accelerates oncogenic activity and tumor growth,” stated Carl Ware, Ph.D., professor and director of Infectious and Inflammatory Disease Center at Sanford Burnham Prebys Medical Discovery Institute.
ONXEO Provides Update On Nanoparticle-Based Livatag Phase III Trial For Hepatocellular Carcinoma
The international Phase III trial ReLive is assessing Livatag’s efficacy on survival in 400 advanced HCC patients following treatment after failure or intolerance to Sorafenib. The delivery of Livatag to HCC cells via nanoparticles short-circuits the body’s drug resistance by masking the anticancer agent. Enrollment is at 50% and 6 previous Data Safety and Monitoring Boards (DSMB) have given the greenlight to continuation of the study; the next DSMB will take place in October 2015 as the trial nears its end.
Transplant Versus Resection For Hepatocellular Carcinoma
Two studies discussed the pros and cons of transplant and resection in HCC patients. The first study showed that, overall, liver transplantation does provide better disease-free survival, but that the scarcity of organs available made resection a necessity. The second study illuminated the potential for living donor liver transplants (LDLT) and showed how the recurrence of HCC was the same regardless of the liver source.
New Approaches in Hepatocellular Carcinoma
VIDEO: A panel of doctors and clinicians discuss new treatment options for patients with HCC.
Researchers Find Link Between Cancer Gene and Obesity
Virginia Commonwealth University researchers have discovered new functions for the Astrocyte elevated gene (AEG-1). In preclinical experiments in the lab with mice, the team combined molecules that blocked the expression of AEG-1 with retinoic acid (vitamin A) and delivered the drug intravenously via nanoparticles into mice with transplanted human liver cancer cells. “What we found is that the tumor disappears,” said Devanand Sarkar, PhD., at VCU Massey Cancer Center. “Anything delivered intravenously goes to the liver first, so the success of our experiments suggests that this might also be an effective way to treat liver cancer in human patients.”
New Tool To Predict Risk Of Liver Cancer Relapse
After examining 405 first-line liver resection patients from 1992 – 2007, researchers have compiled a questionnaire that gives doctors an accurate prognosis for recurrence of cancer in those patients at three and five years after surgery. “With this information, follow-up surveillance can be better calibrated for our patients, and patients can be better selected to undergo future follow-up treatments,” stated Dr. Tan Min Han, visiting consultant of National Cancer Center Singapore (NCCS).
Tenofovir May Reduce Risk Of Liver Cancer In Patients With HBV Infection
A new study shows a decreased incidence of Hepatocellular Carcinoma among chronic HBV patients who are treated to long-term therapy with tenofovir disoproxil fumarate (TDF). “TDF is an oral antiviral medication used to treat HIV infection in combination with other drugs and chronic HBV infection.”
Researchers Identify DPP9 Enzyme That Can Regulate Growth, Movement Of Liver Cancer Cells
Human liver cancer cell growth and movement have been shown to be regulated by the DPP9 enzyme. Australian researchers have found that many of the molecules that are de-activated by DPP9 are important to immunity or regulating energy use and storage and could therefore be harnessed for clinical use. “The research could lead to major breakthroughs in the treatment of cancer, as well as in the understanding of the immune system and growth of stem cells.”
Leading Danish Cancer First In Europe To Use Varian’s Calypso Transponders For Liver Cancer Patients
Aarhus University Hospital in Denmark has treated two liver cancer patients with stereotactic body radiotherapy (SBRT) using Calypso®’GPS For The Body’ transponders for live monitoring during treatment. This feature gives surgeons proof that the dose is being delivered precisely where it should be. “In the past, we would have to apply a more generous treatment margin around the tumor because of uncertainties regarding the precise tumor position from day to day. Calypso® allows us to monitor the treatment real-time and reduce the treatment margin, meaning less healthy tissue is treated,” said Martin Hoyer, professor of clinical oncology at Aarhus.
Kowa Company Ltd., a Japanese multinational, has entered into a licensing agreement with Chugai Pharmaceutical Co. Ltd., for peretinoin, the first drug developed to prevent the recurrence of HCC. “Through the introduction of peretinoin to the market, Kowa and Chugai expect to contribute to patients, their families, and medical professionals by fulfilling unmet medical needs and providing new treatment options.”
Novel Agents Show Early Promise In HCC
A sampling of early phase HCC clinical trials presented as ASCO 2015. In a phase I/II study, TRC105 in combination with sorafenib was given to HCC patients who did not respond to other treatments. Only 25% of patients had stable disease and progression-free survival (PFS) was 4.1 months at the prescribed dose; PFS was 5 months at a slightly higher dose. A 20 patient pilot study combined tremelimumab with transcatheter arterial chemoembolization (TACE) or radiofrequency ablation (RFA). The full population experienced PFS of 7.4 months. This trial is ongoing and hopes to enroll 60 patients. A third study that was a phase II trial evaluated the combination of Axitinib and TACE in 50 patients with inoperable HCC, showed median overall survival (OS) of 15.9 months. Two-year OS was 41.9% and median time to progression was 10.4 months.
Blueprint Medicines Plans To Start First Two Cancer Drug Trials By Fall
The FDA has approved the company’s drug BLU-554 for the treatment of Hepatocellular Carcinoma. The Phase I trial is expected to start by this September with sites in the U.S., Europe and Asia.
New Chemoablative Approach For Hepatocellular Carcinoma and Metastatic Liver Disease
PV-10, a 10% rose bengal solution created specifically to stain necrotic tissue in the cornea, was used in two cohorts of cancer patients: six patients with non-resectable HCC and seven patients with other forms of metastatic liver cancer. Each patient received a single percutaneous injection to a lesion of a certain size. One patient, a 68-year-old male with HBV and cirrhosis-related HCC, was alive at 54 months follow-up with no cancer in his body. In total, 10 out of the original 13 patients were still alive at 54 months post-treatment.
ESMO GI Provides New Insights Into HCC and Metastatic Liver Cancer
At the 17th World Congress of Gastrointestinal Cancer of the European Society for Medical Oncology data from the GIDEON study, among others, was presented. The safety of sorafenib in real world HCC populations was the goal of the GIDEON trial, and there were improved outcomes for patients over 70 versus those under 70 years old. Median overall survival was 10 months in the younger group compared to 20 in the older; progression-free survival was 6.1 months for the elderly patients versus 4 months for the younger group.
Novel Protein Class Aids in Detection of Early-Stage Liver Cancer
Researchers at Georgia State University have engineered a protein that allows noninvasive detection of early stage liver metastases in patients with a high likelihood of developing primary and metastatic liver cancers. The protein was developed to be used in MRI contrast agents with improved sensitivity to allow the discovery of smaller tumors. “Our new agents can obtain both positive and negative contrast images within one application, providing double the accuracy and confidence of locating cancerous tumors. These agents are also expected to be much safer with reduced metal toxicity,” stated Jenny Yang, PhD., associate director of the Center for Diagnostics and Therapeutics at GSU.
Nanobiotix: Clinical Trial Starts For Liver Cancer Treatment
The company has received the green light to start a pilot trial for NBTXR3 for the treatment of liver cancers. The Phase I/II trial will include both primary and liver metastases and will study intra-lesion and intra-arterial dosing. Phase II will study the drug’s effect on liver metastases and HCC, both with and without intrahepatic thrombosis. Drug efficacy will be measured by response rate, progression-free survival and safety with initial data available as early as 2016.
Transgene Biotek Gets US Patent For Liver Cancer Molecule
Transgene’s molecule miRNA 101 is being developed as a therapy for Hepatocellular carcinoma. “This granting of a USA patent is a significant step in moving ahead with the development of this novel drug,” said the company in a statement.
AB Science: The Data and Safety Monitoring Board Recommends Continuation of Three Phase 2 Studies
The Data and Safety Monitoring Board (DSMB) has recommended AB Science continue a phase II second-line treatment for Hepatocellular Carcinoma. “The objective of this phase II study is to evaluate the safety and efficacy of mastinib in combination with etoposide, or mastinib in combination with irinotecan in patients with advanced Hepatocellular Carcinoma and who relapsed after a first-line therapy with sorafenib. The study’s endpoint is overall survival.”
Genetic Testing and Second-Line Treatments in HCC
A panel of physicians and surgeons discuss (on a seven-minute video) the value of genetic sequencing in order to know the baseline profile of a tumor in order to match the patient with the right treatment or clinical trial.
Medivir Announces The First Cancer Project Derived From Its In-House Nucleotide Platform30 Jun 2015The company unveiled a liver-targeted nucleotide prodrug to combat Hepatocellular Carcinoma, and it is the first cancer project from its in-house efforts at oncology. “We have identified molecules with excellent activity against a range of HCC cell lines and with the required distribution properties to enable them to be delivered selectively to the liver. Preclinical testing of these molecules in relevant models of HCC will begin early in the third quarter,” said Richard Bethell, EVP Discovery Research.
dlDNA Marks Progression of HBV-Related Liver Disease
In patients with chronic hepatitis B virus, researchers have discovered that the level of serum duplex-linear DNA (dlDNA) increases as liver disease progresses into Hepatocellular Carcinoma. Viral dlDNA is known to be a precursor of HBV DNA into host chromosomes, which may be involved with HCC oncogenesis so reduction of dlDNA may lower the risk of HCC development.
Hepatocellular Carcinoma Market – Global Clinical Trials Review, H1, 2014
This clinical trial report provides data on HCC trials worldwide: trial numbers, recruitment status per site, coverage of clinical trial phase and briefings for the key drugs for treating HCC.
Ely Lilly Cancer Drug Comes Up Short In Liver Cancer Trial
The REACH trial treated advanced liver cancer patients with Cyramza, but the drug did not help patients live significantly longer than the placebo group. The one exception was a sub-group of patients with elevated alpha-fetoprotein who were treated with Cyramza and lived four months longer than patients in the placebo group. Lilly intends to start a new phase III trial to treat and evaluate Cyramza in advanced Hepatocellular Carcinoma patients with elevated alpha-fetoprotein levels.
The Thai Delicacy That Causes Liver Cancer
In northeastern Thailand, liver cancer has been linked to a local dish called koi plaa made from raw fish, red ants, lime juice and herbs. The liver cancer has been linked to liver flukes, a parasite found in raw fish in the region. “We found that the liver fluke can make a chemical that stimulates a host immune response- inflammation-and after many years, this becomes chronic inflammation, which becomes cancer,” said Dr. Branchob Sripa at the Tropical Diseases Research Laboratory at Khon Kaen University. In some communities, researchers found that 80% of the population was infected by the fluke.
Transplantation Versus Resection in Patients with HCC
A panel of HCC researchers and surgeons discuss (in a nine-minute video) the many factors in play when deciding which of the two curative options would be best for patients.
Study Finds Gene Mutations Sensitize Tumors To Specific Cancer Drugs
A gene mutation found in HCC tumors, the ARID1a, disrupts DNA damage repairs in cancer cells, but could be a key to treating the disease. When ARID1a is not functioning normally, cancer cells are more susceptible to treatments that further disrupt cancer cell repair and researchers think this could be a way to treat HCC. The study shows the importance of using genomic information as a way to identify a precise cancer treatment for each individual patient.
A Cell-Surface Protein Overexpressed In Liver Cancer Offers A Promising Target For Therapy
Elevated levels of the protein Agrin helps the growth and spread of HCC in patients, but could also become a target for treatment of the disease. Researchers found a 42% drop in rate of cellular proliferation and a 50% increase in programmed cell death when Agrin expression was blocked in liver cancer cells. “Our study shows that there is immense potential to combine anti-Agrin agents with the already available enzyme inhibitors for effective and improved treatment,” stated Sayan Chakraborty, co-lead investigator at the A*STAR Institute of Molecular and Cell Biology.
Eisai Launches Thyroid Cancer Therapy Lenvima in UK
Lenvima, a drug that targets several factors that can contribute to thyroid cancer tumor growth, is being tested on Hepatocellular Carcinoma in a phase III trial. Lenvima was approved for treatment in the U.S. last February. It is available in Japan and will launch in 20 more countries by the end of fiscal year 2015.
The Same Probiotic That’s In Your Yogurt Could Detect Liver Cancer
For a long time scientists have been looking for a bacterial therapy for treating cancer, but a group from MIT and UC San Diego may have found a way to, instead, detect cancer with bacteria. Nissle 1917, the probiotic found in yogurt that aids in digestion, has been genetically altered so that when it encounters liver tumors it emits a luminescent enzyme that can be seen in urine. “There is a large clinical need for detection of liver metastases at early stages, since there are many methods for treating these at early stages. Survival rates are significantly higher when the cancer is caught early,” stated Sangeeta Bhatia, one of the senior authors of the paper and a professor at MIT.
“This report provides comprehensive information on the therapeutic development for Metastatic Hepatocellular Carcinoma (HCC), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases.”
Nexavar/HAIC With Cisplatin Yields Favorable Results For HCC
In a randomized, phase 2 trial that took place between June 2011- December 2013 researchers treated HCC patients with Nexavar plus hepatic arterial infusion chemotherapy (HAIC) with cisplatin and had better outcomes than treatment with Nexavar alone. Overall, median survival between the two treatments was 10.6 months versus 8.7 months and median time to progression was 3.1 months versus 2.8 months. Masufumi Ikeda, MD., chief of the department of hepatobiliary and pancreatic oncology at National Cancer Center Hospital East, Kashiwa, Japan was quoted: “Sorafenib has been acknowledged as a standard therapy for advanced Hepatocellular Carcinoma and is available worldwide. Hepatic arterial infusion chemotherapy with cisplatin is still often undertaken in Japan, because a favorable tumor-shrinking effect and long-term survival of the patients are sometimes observed even in patients with highly advanced HCC.”
Nivolumab Shows Promise For Advanced Hepatocellular Carcinoma
Researchers evaluated data from 47 advanced HCC patients treated with nivolumab and saw tumors shrink 19%, which is an improvement over the 2-3% response rate of current standard of care sorafenib. One patient had tumor stabilization for 17 months. Overall survival of 12 months was achieved in 62% of patients; OS of 12 months with sorafenib is 30%. “We are encouraged to see that nivolumab was safe overall, and the response rate as well as preliminary survival data look quite promising,” stated Anthony B. El-Khoueiry, M.D., associate professor of clinical medicine at the USC Norris Comprehensive Cancer Center.
Anpac will introduce its Cancer Differentiation Analysis (CDA) technology to detect HCC sooner. “The CDA technology is a blood-sample based, multi-level, multi-parameter diagnostic method which detects signals from both proteins and cells, in which multiple aspects of information are collected to improve diagnostic accuracy.”
An overview of 238 products in active development in the liver cancer pipeline.
Sen ‘Derrick Marks’ High School Prom Date Dies From Liver Cancer
Khameyea Jennings, a Jacksonville, Florida teenager who recently attended her high school prom with NFL player Marks, passed away from liver cancer on May 21st. Marks met Jennings when he visited Wolfson Children’s Hospital when she was undergoing treatment. He brought her a bouquet of flowers and asked her to the prom at the Frank H. Peterson Academy of Technology. Marks was quoted as saying that he, “...wanted to make a difference,” and “... do something where you actually make someone’s day, to make a difference in someone’s life.”
Milestone For e-Therapeutics As First Patient Is Enrolled Into Second Phase Cancer Drug Trial
The company’s cancer drug ETS2101, in combination with Sorafenib, will be monitored for tolerability, safety and anti-tumor activity in newly diagnosed HCC patients. The drug has shown in the lab that it can kill all cancer cell-types tested and in three Phase I trials has shown that it can halt tumor progression. Steve Self, development director of e-Therapeutics said,” This study is directed towards further clinical development of the compound and will inform our understanding of the drug in this therapeutic area.”
Livers Donated After Cardiac Death Are Safe To Use In Liver Cancer Patients On A Transplant List19 May 2015Liver cancer patients can be saved with a liver transplant, but many die waiting due to a shortage of organs and because most transplant centers use organs from donors who pass away due to brain death. Transplant physicians at the Mayo Clinic in Florida, in the largest study of its kind, have found that livers that come from donors who die from cardiac death can give liver cancer patients new hope. “I believe this study firmly and finally answers the question as to whether liver donations after cardiac death are as viable for patients with liver cancer as livers from donors who die from brain death. They are,”stated Kristopher P. Kroome, M.D., Mayo Clinic.
New Imaging Method Spots Liver Cancer at Early Stage
Magnetic resonance imaging (MRI) is the leading method to detect disease that does not use radiation, but is not as effective at detecting tumors at an early stage. Researchers have developed a new type of protein-based contrast agent to be used with an MRI that has discovered early stage liver cancer tumors with a high degree of sensitivity. “Our new agents can obtain both positive and negative contrast images within one application, providing double the accuracy and confidence of locating cancerous tumors,” stated Jenny Yang, lead study author at Georgia State University.
Sirtex Medical Shares Surge on Liver Cancer Trial Results and Strong Sales
Results from the Sirflox trial treating liver cancer patients with Sirtex’s radioactive spheres have increased progression-free survival from 7.9 months to 20.5 months. “The reduction in the risk of tumor progression in the liver, coupled with the statistically significant nature of the result is encouraging,” said Sirtex chief executive Dr. Gilman Wong. Clinicians are waiting for full trial results to be divulged and are waiting for the Sirflox trial to be viewed in tandem with other trials awaiting results in 2016.
MD Anderson Researchers Find Significant Clinical Variations Among Liver Cancer Patients
Hepatitis B virus (HBV) and hepatitis C virus (HCV) present clinical variations among HCC patients that suggest the viral cause of the disease be considered when developing a treatment plan. The form of hepatitis is not currently a deciding factor in planning, but the study provides evidence that hepatitis type could determine better drugs and treatment modalities for patients.
Diabetes Increases Risk for Hepatocellular Carcinoma In Adults With Hepatitis B Virus
Taiwanese researchers conducting a nationwide cohort study found that HBV patients recently diagnosed with diabetes were more likely to develop HCC than those patients without diabetes. The study took into account a host of factors including age, gender, cirrhosis and obesity and found that diabetes was an independent predictive factor for HCC. “Every effort should be made in prevention of diabetes in chronic hepatitis B patients to lower the risk of HCC. New onset diabetes in chronic hepatitis B patients should be actively treated as a part of prevention of HCC,” concluded the researchers.
Can-Fite’s Phase II Liver Cancer Trial Approved in Europe
The company recently received the go-ahead from the European Medicines Agency to use CF-102, a small, orally bioavailable drug, as a second-line treatment for advanced HCC. In pre-clinical and clinical trials, the drug has shown strong anti-tumor activity and cell death in liver cancer cells. The study will investigate the efficacy and safety of the drug compared to a placebo.
FDA Clearance For Liver Navigation System
The CAS-ONE LIVER device guides surgical instruments in open liver surgery for effective tumor removal and navigated ablation while protecting healthy parts of the liver. CAS-ONE does this using infrared-based instrument tracking and intra-operative 3D ultrasound imaging of the patient’s anatomy to guide surgical instruments in real time. The FDA clearance makes CAS-ONE another treatment option for the 80,000 US patients diagnosed with primary and secondary liver cancer every year.
Evolution of Treatment for HCC: Sorafenib and Beyond
In late 2007, the FDA approved sorafenib for treatment of unresectable HCC after the SHARP (Sorafenib HCC Assessment Randomized Protocol) trial demonstrated improved median time to progression in patients. Since then, researchers have been building on this success by combining sorafenib with TACE, radiation, chemotherapy, immunotherapy and molecularly targeted therapies. Each approach is summarized in the article.
Hot Chocolate Lead Singer Errol Brown Dies From Liver Cancer
The lead singer for the band Hot Chocolate has died from liver cancer at the age of 71. The Jamaican-born singer was known for such hits as “Sexy Thing’, “Every 1’s A Winner,” and “Emma”. Brown was made a Member of the British Empire (MBE) by Queen Elizabeth in 2003. He passed away at his home in the Bahamas and is survived by his wife Ginette and daughters Colette and Leonie.
Jacksonville Jaguars Defensive Tackle Takes Girl With Liver Cancer to Prom
Khameyea Jennings, 18, was diagnosed with liver cancer on Mother’s Day 2013. She had planned to attend the prom with her sister, but that changed after Sen’ Derrick Marks, defensive tackle for the Jaguars visited her at Wolfson Children’s Hospital. He brought a bouquet of flowers and asked if she had a date to the prom. “Laquandra Jennings said her daughter was looking forward to a night that was free of needles, chemo and potassium levels.”
The time to progression after neo-adjuvant treatment with transarterial chemoembolization (TACE) and Sorafenib before liver transplant in HCC patients was comparable to TACE and a placebo. Patient safety was similar in the Sorafenib versus placebo group, as well.
Provectus will present, “Phase I Study of PV-10 for Chemoablation of Hepatocellular Carcinoma and Cancer Metastatic to the Liver.” PV-10 is the company’s investigational drug for solid tumors such as HCC. It is designed to be injected directly into the tumor to reduce systemic side effects.
Novel Therapeutic Candidate Targets Key Driver of HCC in Genomically Defined Subset of Patients
BLU-554 is a small-molecule investigational drug that shows promise as a possible treatment option for up to 30% of HCC patients. Study authors indicated that BLU-554 showed significant anti-tumor activity in liver cancer models and was well tolerated at the highest dose level. “Most people are diagnosed with Hepatocellular Carcinoma once the cancer is at an advanced stage and the outlook is poor. Median survival time from diagnosis is about six months. Finding new disease drivers and treatment options for patients with Hepatocellular Carcinoma is critical to make strides against this devastating disease,” stated Dr. Laurent Castera, Vice-Secretary, European Association for the Study of the Liver.
Cancer Rates Among Patients With Hepatitis C Are Increased Compared To Those Not Infected
In a retrospective study at Kaiser Permanente, Southern California between 2008-2012, incidence of liver cancer and all cancers was compared between patients with and without hepatitis C. Incidence of all types of cancer was 2.5 times higher in those patients with HCV; when liver cancer was excluded in HCV patients the incidence of cancer was 2 times higher. “The results suggest that cancer rates are increased in the cohort of hepatitis C patients versus the non-hepatitis C patients, both including and excluding liver cancers. These findings certainly point to the suggestion that hepatitis C may be associated with an increased risk of cancer,” said Lisa Nyberg, MD from Kaiser in Southern California.
Genomic Analyses Point to the Potential of Personalized Care for Liver Cancer Patients
Researchers using exome sequencing, a technique for sequencing all the protein-coding genes in a genome, are hoping to understand how and when carcinogenic mutations occur in patients with HCC. The team hopes that the molecular profiles created will help identify which anti-cancer treatments would best suit patients for their particular subtype of HCC. “Genomic analyses, such as exome sequencing, allow us to better understand the mutational processes involved in the development of cancers. This detailed knowledge then helps us to unravel the mutagenic processes and to optimize personalized patient care,” said Markus Peck, Secretary General, European Association for the Study of the Liver.
Combo Approach Fails in Liver Cancer Trial
South Korean researchers found that orantinib combined with chemoembolization had no effect on Hepatocellular Carcinoma compared to transcatheter arterial embolization. Nexavar was also used in this combination approach with similar results. Said Markus Peck-Radosavljevic, MD., Medical University of Vienna, the findings, “... really confirm my own feeling that in this setting it’s better to use the treatments sequentially rather than concomitantly.”
Immunicum Updates Safety and Survival Data in Liver Cancer Study with INTUVAX
The company is conducting a phase I/II open-label study with the purpose of determining patient safety and immunological response to Intuvax in the treatment of primary liver cancer. Eight patients with HCC have been treated thus far and six of those have received all three Intuvax doses. Twelve patients are to be included in the study and final data is expected by the end of the year.
Lethal Liver Cancer Can Be Spotted Early
Hepatocellular Carcinoma is the most common type of liver cancer and the third leading cause of cancer-related death worldwide, in large part because it is usually detected at a late stage. Georgetown researchers have found that a damaged lesion on a DNA base was related to the development of HCC in two mouse models. “It has the potential to serve as a biomarker for early detection of Hepatocellular Carcinoma,” said Ying Fu from the Georgetown Lombardi Comprehensive Cancer Center in Washington D.C.
FDA, SillaJen Agree To Begin Phase 3 Liver Cancer Trial
The clinical trial of Pexa-Vec for the treatment of advanced liver cancer will begin enrolling patients later this year. The primary goal is to determine overall survival with the drug, followed by Nexavar, as compared to sorafenib alone. The randomized trial will accept 600 patients with advanced HCC who are eligible to receive sorafenib and be conducted at 120 sites in North America, Asia and Europe. Ghassan Abou-Alfa, MD, medical oncologist at Memorial Sloan Kettering Cancer Center said,” Cancer immunotherapy is making a significant impact across multiple cancer types and we hope this trial will bring a novel immunotherapy to liver cancer patients, particularly given the limited viable treatment options available to this treatment population.”
Immune Cells Can Promote Liver Cancer
Immune cells called neutrophils that normally act to protect us from infections have been found to promote cancer in liver cells that are already damaged due to chronic disease. One of the effects that neutrophils produce is an increase in Reactive Oxygen Species (ROS), which normally helps the immune system, but, at high levels, can damage cellular components and DNA. Dr. Derek Mann, professor of Hepatology at Newcastle University’s Institute of Cellular Medicine commented,” Now we know that neutrophils are the culprits we can move forward with new studies aimed at stopping their cancer-promoting activities in high-risk patients suffering from severe liver disease.”
Smooth Crooner Percy Sledge Loses Battle With Liver Cancer
The singer is most known for his very first song, “When a Man Loves a Woman,” which became a hit worldwide and was the first album to go gold for Atlantic Records. Sledge was inducted into the Rock and Roll Hall of Fame in 2005. Michael Bolton gave the song new life when he revived it in 1991 for a whole new generation to enjoy. Sledge passed away after a long battle with liver cancer at the age of 73.
UMC Utrecht’s New Liver Cancer Treatment Approved For Use In Europe
The new treatment injects radioactive holmium microspheres into the hepatic artery where they become trapped in the tiniest blood vessels of the tumor in a treatment called radioembolization. “Treating tumors with yttrium microspheres is already a proven and valued cancer therapy... The new holmium microspheres constitute the next step in the development of this technology,” said Dr. Frank Nijsen, founder of Quirem and the new treatment. “Because they show up on MRI scans and SPECT-CT, these microspheres can be tracked, allowing customized treatment for each individual patient.”
Bavituximab/Nexavar Found To Be Effective For Advanced HCC
Patients with advanced HCC showed improvement in a phase 2 clinical study after the combined therapy of bavituximab and Nexavar. Time to progression of the disease improved to 6.7 months, disease-specific survival was 8.7 months, a disease control rate was 58% and a 4-month progression-free survival was 62%. “The combination of bavituximab and sorafenib was well-tolerated in patients with advanced HCC with no indications of autoimmune adverse events that have been seen with other checkpoint immunotherapies,” stated Adam Yopp, MD, assistant professor of surgery at UT Southwestern Medical Center and surgical oncologist at University Hospital Surgical Oncology Clinic at Simmons Cancer Center, Dallas.
Delcath Adds New U.S. Center To Global Phase 2 Hepatocellular Carcinoma Program
Montefiore Medical Center in the Bronx, New York has joined two other centers in the U.S. and three in Germany. The Phase 2 study is now open for patient enrollment and will investigate safety and efficacy of Melphalan/HDS treatment followed by sorafenib in patients with unresectable liver cancer confined to the liver.
Tazo Tea Luminary Steven Smith Died of Liver Cancer Caused by Hepatitis C, A Hidden Epidemic
The founder of Stash Tea Company and Tazo Tea succumbed to a two-year battle with liver cancer caused by hepatitis C. Steven likely contracted HCV from a blood transfusion in the 1980s, before the blood supply was monitored. Years later, Steven was denied life insurance because the virus was detected in his system after a blood test. The virus moves very slowly and it is estimated that, like Steven, 3.5 million Americans do not know they have the HCV virus. Following the death of her father, Carrie Smith-Prei wrote, ”He passed peacefully as we all breathed together and held him close to our hearts. Thank you for all of your love and thoughts for these past days.”
Generic Hepatitis Drug Launched In India As Hepcvir
Sofosbuvir, the generic hepatitis C treatment, has been approved for production in India under the name Hepcvir. The high potency pill has a good safety profile and has shown cure rates around 90% when used in combination therapy. “The benefits of Hepcvir will be felt by patients who will have much lower discomfort while on the treatment and therefore much higher levels of adherence. Sofosbuvir marks a new era of medicines in oral treatment of hepatitis C, which reduce the need for injectibles. It is hoped in the future these drugs will eventually mean a totally oral regimen,” said Dr. Jaideep Gogtay, Chief Medical Officer, Cipla.
Tumor Profiling Model Finds Potential Therapeutic Agents for HCC30 Mar 2015A retrospective study by Caris Molecular Intelligence discovered molecular patterns and therapeutic options in the treatment of HCC. Liver cancer tumors can have molecular differences that can have an enormous impact on what treatments are effective or not. “This data demonstrates how molecular profiling can reveal potential actionable targets in HCC to provide additional treatment options for patients,” stated Celina Ang, M.D., researcher at the department of hematology at Icahn School of Medicine, Mount Sinai Hospital.
The treatments for HCC are extremely limited, but Caris researchers have identified therapies that are not normally considered to treat specific molecular subtypes of the disease. Gene sequencing, protein expression analysis and gene copy number analysis were some of therapeutic options explored. “Patients with HCC have limited therapeutic options and there is little guidance for clinicians when weighing the next therapeutic steps...,” stated lead investigator Celina Ang, M.D., at the Icahn School of Medicine, Mt. Sinai Hospital in New York, N.Y. “This data demonstrates how molecular profiling can reveal potential actionable targets in HCC to provide additional treatment options for patients.”
EDAP to Participate in Major, Multi-Partner Liver Cancer Development Project
French company EDAP, maker of Ablatherm the high-intensity focused ultrasound (HIFU) treatment for localized prostate cancer, has announced a major collaboration. The company will participate in HECAM (Hepatocellular Carcinoma Multi-Technological), a consortium of industrialists, academicians and clinicians who will work to develop multi-faceted technologies for the early diagnosis of liver cancer, imaging techniques to assist in therapy decision, planning, and follow-up and the treatment of HCC using technologies such as HIFU. “Liver cancer is a major disease with substantial health and economic consequences, and we believe that our wealth of experience in treating tumors using HIFU could lead to improved treatment options and patient survival,” said Emmanuel Blanc, EDAP’s Chief Technical Officer.
Cipla Launches Generic Drug Sofosbuvir in India Under Brand Name ‘Hepcvir’
Sofosbuvir is a first-in-class hepatitis C treatment with a high potency, high-barrier to resistance and good safety profile with limited drug-drug interactions. When used in combination with other drugs Sofosbuvir has shown to have cure rates as high as 90%. “The benefits of Hepcvir will be felt by patients who will have much lower discomfort while on the treatment and therefore much higher levels of adherence. Sofosbuvir marks a new era of medicines in oral treatment of hepatitis C which reduce the need for injectibles,” stated Dr. Jaideep Gogtay, Chief Medical Officer at Cipla.
The company published pre-clinical data on BLU9931, a therapy that resulted in significant reduction of Hepatocellular Carcinoma tumors in in vivo models. “The profound anti-tumor activity of these exquisitely selective kinase drugs demonstrates promising preclinical proof-of-concept in a disease with a high unmet need and no approved genomically targeted therapies,” said Andy Boral, M.D., Ph.D., Senior Vice-President, Clinical Development Blueprint Medicines.
OncoSil Medical to Add Liver Cancer to Treatment Platform16 Mar 2015OncoSil is an implantable device that delivers localized radiation to a specific targeted tumor for months, if needed. The treatment platform has been used to fight pancreatic cancer up until now, but clinical data show the treatment to be effective against HCC, as well. The company hopes to clear regulatory hurdles in the European Union in the second half of the year; it is unknown when the treatment will be available to patients.
Long-Term Entecavir, TDF Effective in Chronic HBV in Real-World Setting13 Mar 2015A Turkish study shows that long-term virological and biochemical responses can be achieved in chronic HBV patients with a combination of entecavir and tenofovir disoproxil fumarate (TDF) treatment. HCC developed in a lower proportion of patients compared to previous studies, but the researchers cannot prove that this was a consequence of the therapy. The team reports that entecavir and TDF were well tolerated and posed no safety-related complications in patients.
Tunku Abdul Jalil, who was diagnosed with liver cancer in June of 2014 and underwent a successful liver transplant, has established The Tunku Laksamana Johor Cancer Foundation to offer Malaysians financial assistance to treat the disease. “It is my hope that cancer patients will be cured. I have gone through what they are going through, and I know how hard it is to live with cancer,” said Jalil.
Nigeria: Liver Cancer Kills 11,663 Nigerians Annually—Expert
The figure was disclosed by the Dr. Abia Nzelu, Executive Director of the Committee Encouraging Corporate Philanthropy. Nzelu noted that hepatitis B, a major risk factor for liver cancer, could be reduced with the HBV vaccination which is now included as part of the National Immunization Program (NPI).
Treatment of Primary Liver Cancer: SARAH Study Completes Enrollment, Results Expected Late 2016
SARAH (Sorafenib versus Radioembolization in Advanced Hepatocellular Carcinoma) is a Phase III multi-center randomized open-labelled study for advanced HCC patients whose disease has spread or who are ineligible for surgery or transplant. The French study has exceeded its 400 patient enrollment and will compare the effectiveness of selective internal radiation therapy (SIRT) using yttrium-90 microspheres versus sorafenib. The primary goal of SARAH is to determine if there is increased survival with radioembolization versus sorafenib and to compare quality of life with the two treatments.
Deferring Hepatitis C Treatment Can Lead to Liver Cancer and Death, Despite Cure
Delaying hepatitis C treatment for people with HIV and HCV co-infection puts them at risk for liver failure, Hepatocellular Carcinoma and liver-related death, even after they are cured. Swiss researchers used a mathematical model to simulate patients from early stage liver disease (F0) to late stage (F4) and found that starting treatment one month to one year after diagnosis dramatically reduced the proportions of people who developed HCC or succumbed to liver-related death. If treatment was deferred to liver stage F2 or F3 the rate of liver-related death doubled and if it was deferred to stage F3 or F4 the rate went up five-fold. “Our model suggests that timely treatment of HCV infection is important,” stated the researchers. “Patients can progress to end-stage liver disease after HCV clearance if treatment is delayed until later stages of liver disease due to imperfect treatment responses and residual fibrosis progression in HIV-infected patients.
UK Data Confirm Protective Effect of Statins Against Liver Cancer
Statins target cholesterol, which is produced in the liver, and there is evidence that statins can also protect against liver cancer. According to a case-control study in the UK, people taking statins had a lower risk of developing liver cancer, confirming earlier data out of China.
Prophylactic Effect of Urea-Based Cream on Sorafenib-Associated Hand-Foot Skin Reactions
A Phase III study showed that 21% of 297 HCC patients taking sorafenib developed hand-foot skin reactions that severely affected their health-related quality of life. Urea-based cream reduced skin reactions in patients and improved their quality of life, it was found. There is no consensus on quality of life care for patients enduring these symptoms of sorafenib treatment, but the urea-based creams are inexpensive, well tolerated and readily available to the public.
Death Rates Rising For Liver Cancer, Falling For Colorectal Cancer
The American Cancer Society (ACS) reports that death rate for liver cancer from 2007 – 2011 rose by 2.5% per year. In 2011, 10 out of 100,000 men died while 4.7 out of 100,000 women died. The lowest death rate for men was in 1980 when it was 5.8; for women the low was 1987-1988 at 4.1. “Screening for liver cancer has not been shown to reduce mortality. Nonetheless, many doctors in the U.S. screen individuals at high risk for the disease (e.g., those with cirrhosis) with ultrasound or blood tests,” the report stated.
The UK Dietary Guidelines Advisory Committee has concluded that 3 to 5 cups of coffee a day could reduce the risk of liver disease. Tom Brenna, member of the committee and a nutritionist at Cornell University said, “Coffee’s good stuff. I don’t want to get into implying coffee cures cancer—nobody thinks that. But there is no evidence for increased risk; if anything, the other way around.”
Stopping Inflammation-Related Cancers
Chinese researchers have found a way to target the pathological function of a culprit molecule rather than its gene expression in inflammatory cancers such as Hepatocellular Carcinoma. The team found that the FAT10 protein, present in tissues of the immune system, promotes tumor expression and growth when it is overexpressed. When FAT10 interacts with MAD2, a gatekeeper protein that insures that each cell receives the same number of chromosomes, the function of MAD2 is compromised causing cells to carry too many chromosomes, which lead to cancer. Disrupting this interaction can prevent cancer. The researchers’ goal is to identify and design drugs that can specifically impede the interaction of FAT10 and MAD2 in the genesis of inflammation-associated cancer.
“Awakenings” Author Oliver Sacks Reveals He Has Terminal Liver Cancer, Outlines His Last Days
The author of the 1973 book made into the 1990 Academy Award-nominated film starring Robin Williams and Robert DeNiro, Sacks has announced that he has terminal liver cancer. “Awakenings” is about a group of patients who contracted sleeping sickness after World War I and who woke up in 1969 after Sacks gave them an experimental drug. “I cannot pretend that I am without fear. But my predominant feeling is one of gratitude. I have loved and been loved; I have been given much and I have given something in return; I have read and traveled and thought and written. I have had an intercourse with the world, the special intercourse of writers and readers. Above all, I have been a sentient being, a thinking animal, on this beautiful planet, and that in itself has been an enormous privilege and adventure,” wrote Sacks in an op-ed in the New York Times.
Researchers from Sun Yat-sen University Cancer Center in Guangzhou, China found that overall survival improved for sorafenib-treated HBV-related HCC patients when they received antiviral therapy with nucleoside analogues (NAs). Patients treated with NAs lived 16.47 months versus 13.10 months without NAs; risk of death was significantly reduced in the NA-treated patients compared to non-NA patients.
HCC Incidence Occurred In Patients Undergoing Monotherapy For HBV
In a retrospective cohort study of Caucasian patients with chronic HBV, scientists found that after successful long-term monotherapy with the nucleoside analogues (NAs) entecavir and tenofovir patients could still develop HCC. Researchers stated that patients with more advanced stage liver disease and cirrhosis had an increased risk of this outcome.
Scientists Make Key Find in Treating Liver Cancer
Researchers in Singapore have discovered that blocking the Agrin protein not only stopped liver cancer tumors from growing in mice, it made them shrink by 40%. Agrin is a protein that helps liver cancer cells to grow and spread throughout the body. Researchers need to find antibodies that will work for people, but stated that these findings show that Agrin could be an important treatment to help detect and stop liver cancer in the future.
Updated Guidelines Help Prioritize Treatments in Hepatitis C
The Infectious Diseases Society of America and the American Association for the Study of Liver Diseases have issued new guidelines in the treatment of hepatitis C. They recommend that patients with advanced fibrosis or compensated cirrhosis, a liver transplant or severe extrahepatic complications should be first priority for treatment. Next in line are those patients with comorbidities, such as HIV-1 infection, HBV, porphyria cutanea tarda and Type 2 diabetes mellitus that increase the risk of serious HCV complications. New treatments can cure or slow HCV damage and those that achieve a sustained virological response (SVR) are 70% less likely to develop HCC.
Six Research Developments About Patients With HCC
In commemoration of World Cancer Day today, Healio.com/Hepatology has put together a list of the latest research on advancements in the fight against Hepatocellular Carcinoma.
Liver Cancer Australia’s Most Deadly Cancer
The Hepatitis Australia analysis shows that for every one Australian that is diagnosed with HCC, another will die. This is the highest death-to-incidence ratio of any cancer in the country. Liver cancer is the fastest growing cause of cancer death in Australia with 1400 people dying each year and a third of patients dying within a month of diagnosis. Kevin Marriott, acting CEO of Hepatitis Australia, says the country needs greater investment in community education, needle and syringe programs, hepatitis B vaccination and improved diagnosis and treatment for the disease.
Massive Hepatitis B Impact on Liver
According to the Hepatitis B Mapping project, of the 220,000 Australians living with chronic hepatitis B only 57% are diagnosed and only 13% are receiving treatment. The first Hepatitis B mapping project showed a geographically uneven spread of HBV across Australia highlighting where the need for action is the greatest. “The national hepatitis B strategy sets a target to increase the proportion of people living with chronic hepatitis B who are receiving antiviral treatment to 15%. It’s currently five percent. Increasing uptake of treatment is a means to achieving a significant and sustained reduction in mortality attributable to advanced liver disease and liver cancer,” stated the report’s authors.
Prostate Cancer Not More Common in Hemophiliacs
In a study at Veterans Hospital in Taichung, Taiwan researchers found that among hemophiliacs, overall incidence of cancer was 4.7% versus 1.9% for the general population. Hepatocellular Carcinoma was the most observed cancer among hemophiliacs.
Age and HBsAg Level Predict NA-Induced HBeAg Seroconversion Durability
Taiwanese researchers have discovered a way to predict which hepatitis B patients will relapse after (NA) nucleostide analogue treatment is completed. NA suppresses the replication of the HBV virus. The age of the patient (40 and over) and a certain baseline of the hepatitis B s-antigen were accurate indicators of HBV relapse, independently and when used together. In a study with 157 participants, 82 patients relapsed over a 5-year follow-up with a mean time to relapse after NA treatment of 13.9 months.
Baseline AFP Levels Affect Ramucirumab Benefit In HCC20 Jan 2015Results from the REACH study of HCC has found that the level of alpha-fetoprotein (AFP) in the bloodstream can be a marker for selecting patients who would benefit from ramucirumab treatment. “In a post-hoc analysis of REACH, ramucirumab treatment led to a greater reduction in the risk of death of patients with progressively higher baseline AFP values. Further investigation of the relationship between baseline AFP level and angiogenesis is currently ongoing to better understand ramucirumab mechanism of action in HCC,” stated Andres X. Zhu, MD, Massachusetts General Hospital Cancer Center.
Terpenes Inhibit Liver Cancer19 Jan 2015Terpenes, the main component of essential oils, have been found to inhibit the growth of liver cancer cells. HCC cells exposed to terpenes created a calcium concentration, which reduced cancer cell growth. “These results are yet another example for the significance of olfactory receptors outside the nose, and they give rise to the hope that new drugs with no severe side effects may be developed for cancer therapy,” stated the research team.
AbbVie’s New Hepatitis C Treatment Gets Approval in EU19 Jan 2015Pharmaceutical company AbbVie’s all-pill hepatitis C treatment is a combination of Viekirax and Exviera. Viekirax is a combo pill containing the antiviral drugs ombitasvir, paritaprevir and ritonavir; Exviera is a single pill that contains only dasabuvir. Viekirax and Exviera are part of the new generation of hepatitis C treatments that are expensive, don’t require injections, have fewer side effects and cure in eight weeks nearly all patients. In patient studies, the combo treatment cured from 95 – 100% of those infected with subset 1 of hepatitis C.
Peregrine Pharma (PPHM) Presents Bavituximab Combo Phase 2 Data in HCC
The company conducted a single-center, single-arm, open-label investigator-sponsored (IST) trial with 38 patients with advanced HCC who were treated with bavituximab and sorafenib. Data from the combined therapy showed an improved time to progression of 6.7 months, a disease specific survival of 8.7 months, a disease control rate of 58%, and a 4-month progression-free survival of 62%. “These data, along with recently reported translational data from this study, continue to build the knowledge base for the bavituximab clinical program and, in particular, highlight the potential immunotherapeutic synergies of bavituximab and sorafenib,” said Joseph Shan, VP of clinical and regulatory for Peregrine.
GenSpera Announces Positive Phase II Data for Investigational Agent Mipsagargin
The study results showed mipsagargin to be well tolerated and effective in HCC patients and that it reduced blood flow within tumors while not affecting surrounding tissue, thereby stabilizing HCC progression. Said Craig Dionne, PhD., CEO of GenSpera,” Mipsagargin is a first-in-class agent with a novel mechanism of action that is unlike any other drug being tested in patients with advanced liver cancer. Based on the results of this study, we intend to move forward with a large, global Phase III trial.”
Eli Lilly Inks Oncology Deals With Merck, Bristol-Myers
Eli Lilly will combine its drug galunisertib with Bristol-Myers’ Opdivo in a Phase I/II study to evaluate the safety and efficacy of the combined treatment in patients with advanced Hepatocellular Carcinoma, among other diseases.
Team Develops New Tool To Predict Postoperative Liver Cancer Recurrence After Transplant
UCLA transplantation researchers culled data from 30 years of surgical experience to create a predictive calculator, also known as a nomogram, to provide a guide as to which liver cancer patients would be good candidates for transplants. The nomogram crunches three sets of data: pre-transplant radiologic information, three predictive, pre-transplant blood tests and pathological characteristics of the explanted liver. The researchers concluded,” A novel clinicopathologic prognostic nomogram accurately predicts liver cancer recurrence after liver transplant and may guide frequency of post-transplant surveillance and adjuvant therapy.”
Kool and the Gang trombonist Clifford Adams, 62, Dies From Liver Cancer
Adams was a master musician and jazz educator, who, over a 44-year career played with Patti LaBelle, Kool and the Gang, Sonny Rollins and Art Blakey, among many others. Adams’ friends held several fundraisers to fight his liver cancer and establish insurance, but his health had deteriorated to the point that he did not qualify for a liver transplant. “Clifford Adams was a marvelous musician, an important musician, not only in the Philadelphia-Trenton area but both nationally and the world,” said Suzanne Cloud, executive director and co-founder of Jazz Bridge, a non-profit dedicated to helping jazz and blues musicians in need.
The company’s investigational molecule, DCR-MYC, is designed to inhibit the MYC oncogene, which has been shown to promote cancer. Preclinical data showed that DCR-MYC was able to target oncogenes in HCC models and the company is moving forward with human proof-of-concept studies with initial results expected by the end of 2015. “These results further validate the therapeutic hypothesis behind our programs and will help guide Dicerna’s development efforts as we progress the DCR-MYC program in Phase I clinical trials in HCC and other tumor types,” stated Douglas M. Fambrough, PhD., CEO of Dicerna.
MRI Superior to CT For Liver Cancer Diagnosis
Computed tomography (CT) and magnetic resonance imagery (MRI) are both important tools in the diagnosis, characterization and staging of HCC, but it is unknown whether one is better than the other in their diagnostic performance. In a 40-study meta-analysis of HCC detection in patients with underlying chronic liver disease, the MRI produced superior images of lesions, which helped to identify HCC in these patients. Both techniques produced similar results in patients with smaller tumors.
Tracon Eyes A $57.5M IPO To Get Its Cancer Drug Into Phase III
The company’s oncology treatment TRC105 is an antibody that blocks endoglin, crucial to the formation of new blood vessels, subsequently starving tumors and destroying cancer. TRC105 is in midstage study in combination with Nexavar for the treatment of Hepatocellular Carcinoma. The company hopes for positive patient response to the therapy in order to launch a Phase III trial by the end of 2016.
No Benefit of Erlotinib in Combined Hepatocellular Carcinoma Treatment
The Sorafenib and Erlotinib Randomized Trial Protocol for the Treatment of Patients with Hepatocellular Carcinoma (SEARCH) was a Phase III trial comparing Sorafenib plus Erlotinib versus Sorafenib plus placebo. Over 700 advanced HCC patients were treated, but researchers found no significant improvement in overall survival with the combination therapy versus sorafenib plus placebo.