Tuesday, October 6, 2015

Health plan tiers raise drug costs for hepatitis patients

This is important information if you have open enrollment.  Jacques Chambers Open Enrollment article will be featured in the October Mid-Monthly Edition of the HCV Advocate newsletter - Alan

By Bob Herman  | October 5, 2015

A new report says that health insurance companies discriminate against people with hepatitis B and C by charging high out-of-pocket costs for drugs, but the industry lobby has called the analysis “very one-sided” and limited in scope.

The Affordable Care Act prohibits health insurers from discriminating against people on the basis of age, gender or health conditions, and the federal government has already made it clear it will monitor health plans sold on the public exchanges to ensure they meet ACA standards.

The not-for-profit AIDS Institute examined silver-level health plans that were sold on Florida's insurance marketplace in 2015. The group found that eight of the 12 insurers that sold 2015 plans had what it deemed as discriminatory practices for hepatitis B and C drugs. For example, Aetna placed many of its hepatitis drugs on the most expensive tiers with coinsurance rates up to 50%. Humana had a $1,500 prescription drug deductible and also had many of its hepatitis drugs on the highest tiers with large cost-sharing, the report found.

Read more....

Tuesday, September 29, 2015

Walter and Eliza Hall Institute’s Dr Greg Ebert wins Centenary Institute’s Lawrence Creative Prize

A REVOLUTIONARY method of treating hepatitis B has landed a Brunswick doctor a major national award.

Dr Greg Ebert, of Walter and Eliza Hall Institute, has been awarded Centenary Institute’s Lawrence Creative Prize for his innovative work to eradicate hepatitis B by promoting the death of infected cells.

The work is in a trial phase but Dr Ebert, 38, said its impact was promising.


Friday, September 25, 2015

Hepatitis B-like Virus Found in Great Lakes Fish Species

A hepatitis B-like virus has been found for the first time in fish. A team of USGS researchers found the virus in white sucker from the Great Lakes Region using gene-sequencing technologies.
How the recently discovered hepatitis B-like virus is transmitted between fish is not yet understood, and it is unlikely to be communicable to humans.

“To date, a hepatitis B virus has never been found before in fish and we now have evidence that it infects fish in geographically distant river systems in the Great Lakes region,” said lead author Cassidy Hahn, a USGS scientist and graduate student at the University of West Virginia. “This new virus is similar, but also very different from hepatitis B-like viruses found in mammals and birds, and may be a new genus.”

The hepatitis B virus is a small, spherical, enveloped virus, previously known only in two groups--one that infects humans and other mammals including orangutan, gibbons, gorillas and chimpanzee; and the other that infects birds.

The white sucker is considered an indicator species, which is native to river systems in the Midwestern and Northeastern United States. Their widespread distribution and life-history have made them a target species in numerous contaminant monitoring and effects studies. White sucker are bottom feeders, spending most of their lives in close proximity to the bottom of rivers, because of this they are in contact with contaminants associated with the river bottom.

The DNA of an organism is like a recipe book for making all of the proteins necessary for life. Those instructions are coded as genes and are conveyed to protein making factories in the cell via messenger ribonucleic acid molecules. In order to develop tools to evaluate how these fish were utilizing their DNA (responding to their environment), the RNA from liver tissue was sequenced using contemporary high throughput RNA-sequencing methods. This approach allows for decoding the usage of this blueprint.

In general, hepatitis-B viruses have a narrow host range and infection manifests in various ways. In mammals, these viruses infect and multiply in liver cells and are typically associated with acute and chronic liver diseases including fibrosis, cirrhosis, bile duct cancer, and hepatocellular carcinoma. It is estimated that 350 million people are chronically infected with HBV. Hepatitis B viruses in birds are not normally associated with these liver diseases. The potential effects on fish are currently unknown.

According to the research team, the hepatitis “B-like” virus found in the fish is about as similar to the human hepatitis B virus as it is to the bird hepatitis B viruses.

“This new virus may improve our understanding of the evolutionary history of hepatitis B-like viruses,” said USGS biologist Luke Iwanowicz, study coauthor.  “There have been considerable scientific efforts focused on identifying the origins of hepatitis B -like viruses. The genome of this new virus has features not present in any known virus from this family. It is a very exciting discovery.”

According to the researchers, the study may offer the opportunity to develop a new model system to investigate host – pathogen interactions and benefit human medical research.

Part of a joint U.S. Fish and Wildlife/USGS Great Lakes Initiative Project, the study, Characterization of a Novel Hepadnavirus in the White Sucker (Catostomus commersonii) from the Great Lakes Region of the USA, by Cassidy M. Hahn, Luke R. Iwanowicz, Robert S. Cornman, Carla M. Conway, James R. Winton, and Vicki S. Blazer is available in the Journal of Virology online.

Source: http://www.usgs.gov/newsroom/article.asp?ID=4341#.VgXIniu1XwY

Arrowhead Research on target with hepatitis B candidate

Arrowhead Research (NASDAQ:ARWR) was one of the top performers on Thursday morning following publication of results of a clinical study into its hepatitis B drug, ARC-520.

Investors clambered aboard as Arrowhead unveiled the top-line findings from the Heparc-2001 Phase 2a clinical study of ARC-520, which is designed to treat chronic hepatitis B infection by inhibiting the production of all HBV gene products.

The study indicated the drug can effectively and consistently knock down target genes in humans that are HBV E-antigen positive.

To date, 84 humans have received ARC-520 and no adverse events have been rated as serious or severe, no discontinuations have occurred due to an adverse event, and no laboratory results have indicated any end organ toxicity, Arrowhead revealed.

Additionally, nine chimps received six-11 monthly doses of ARC-520 and no safety signals were detected in any chimp.

“These are exciting data that represent a significant leap forward for our DPC platform, ARC-520, and the HBV field,” said Christopher Anzalone, president and chief executive officer of Arrowhead.
“We have achieved the highest knock-down ever reported in humans with RNAi and a safety profile that continues to be excellent. We are optimistic that this will ultimately translate into powerful clinical outcomes for ARC-520 and follow-on candidates against multiple indications,” he added.

Shares rose US$1.23 to US$7.97 in the morning session.

Source: http://beforeitsnews.com/financial-markets/2015/09/arrowhead-research-on-target-with-hepatitis-b-candidate-2846000.html

Thursday, September 24, 2015

ABIVAX Completes Recruitment in Its Phase IIb/III Pivotal Study with ABX203, First-in-Class Therapeutic Vaccine Against Chronic Hepatitis B

PARIS--()--Regulatory News:
“We are very pleased with this important clinical development milestone that demonstrates the efficiency of the relationship between ABIVAX and the CIGB”
ABIVAX (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), a leading clinical stage biotech company developing and commercializing therapeutic anti-viral drugs and vaccines, today announced that it has completed enrollment of all 266 subjects into its pivotal Phase IIb/III clinical trial of ABX203, aimed at demonstrating the safety and efficacy of ABX203, a therapeutic vaccine candidate for the treatment of patients with chronic hepatitis B disease. This is a significant milestone for the company, which recently conducted an IPO on the regulated market of Euronext Paris and set a record among biotechnology companies in France in terms of the amount of funds raised.

We are delighted to announce that ABIVAX has successfully and rapidly fully enrolled 266 patients for this essential study. The enthusiasm of the physicians and investigators involved in the study is evident. This not only highlights the interest in our innovative therapeutic vaccine, but also underlines the medical need for immunotherapy in this indication. This is an important milestone for ABIVAX that should enable us to generate the first study results in Q4/2016,” said Prof. Hartmut J. Ehrlich, M.D., CEO of ABIVAX.
“We are very pleased with this important clinical development milestone that demonstrates the efficiency of the relationship between ABIVAX and the CIGB,” added Luis Herrera Martinez, CEO of the Cuban Center for Genetic Engineering and Biotechnology (CIGB), and Gerardo Guillén Nieto, Director of Biomedical Investigation at the CIGB.

Chronic Hepatitis B (CHB) virus infection is a very severe disease that often leads to life-threatening complications such as cirrhosis and liver cancer. There are approximately 350 million chronic carriers of Hepatitis B virus (HBV) worldwide, and between 1.0 and 1.5 million people die each year from these complications. CHB is present worldwide but its prevalence is highest in Sub-Saharan Africa and in East Asia.

The ABX203 phase IIb/III study is an open-label, randomized, comparative study designed to assess the efficacy of ABX203 to maintain control of Hepatitis B disease after cessation of nucleotide analogs, in particular in controlling viral load for a much longer period of time when compared to current treatment options. This study is ongoing in seven Asian/Pacific countries (Taiwan, Hong-Kong, Thailand, Singapore, South Korea, Australia and New-Zealand). In this large scale controlled and randomized study, one group of patients will receive ABX203 for 24 weeks, in addition to the current standard of care (nucleoside analogues, NUCs, along with alpha interferon); therapy will be stopped after 24 weeks. These patients will be evaluated against a control group receiving NUCs only. The study’s primary efficacy endpoint is the percentage of subjects with viral load <40 IU/mL at week 48, i.e 24 weeks after the treatment with ABX203 has been completed. Study results are expected in the fourth quarter of 2016.

ABX203 is a therapeutic vaccine composed of 2 recombinant proteins from HBV, the surface antigen (HBsAg) and the nucleocapsid (core) structure (HBcAg). It has been designed to induce the production of neutralizing serum antibodies to HBsAg and the induction of strong cellular responses, which are usually weak or undetectable in patients with CHB. These immune responses are similar to those that occur in patients with a self-resolving acute HBV infection. ABX203 is formulated as a nasal spray solution and as a solution for sub-cutaneous injection.

ABIVAX owns the development and distribution rights for ABX203 for more than 80 territories in Asia, Europe and Africa. These rights were licensed in 2013 from the Center for Genetic Engineering and Biotechnology (CIGB, Havana, Cuba) following the completion of successful phase I, I/II and III clinical trials run by the CIGB. These studies showed that ABX203 was well tolerated and had an antiviral effect similar to that of PEG-IFNα but that this effect on HBV viral load was, in contrast with PEG-IFNα, sustained for at least 6 months after treatment cessation. This unique sustained effect, in addition to a shorter duration of administration, means that ABX203 may offer important therapeutic advantages over standard treatments for CHB.
ABIVAX is an advanced clinical development biotech company focused on becoming a global leader in the discovery, development and commercialization of anti-viral drugs and human therapies to treat some of the world’s most life-threatening infectious diseases, including HIV/AIDS and chronic Hepatitis B.

ABIVAX has 2 compounds in clinical stage research: ABX464 a novel small molecule against HIV with a number of important potential competitive advantages, and ABX203, a therapeutic vaccine candidate that could be a cure for chronic Hepatitis B. The broader ABIVAX portfolio includes additional anti-viral compounds and vaccines that may enter the clinical stage in the coming 18 months.

ABX464 has been developed using ABIVAX’ anti-viral platform that allows the Company to address a broad range of viral targets involved in the production and management of viral RNA within the host cell. ABIVAX also has access to a number of cutting edge technologies including complex molecular protein/RNA-pro interactions to discover and develop proprietary breakthrough therapies to help patients’ clear important pathogenic viruses.

Headquartered in Paris, France, ABIVAX conducts its research and development in Évry (France) and Montpellier (France). In addition, ABIVAX benefits from long term partnerships with the Cuban Center for Genetic Engineering and Biotechnology (Havana, Cuba), The Finlay Institute (Havana, Cuba), the Molecular Genetics Institute of Montpellier (CNRS-Université de Montpellier, France), the Curie Institute (Paris, France), the Scripps Research Institute (La Jolla, CA, USA), the University of Chicago (Chicago, IL, USA), Brigham Young University (Provo, UT, USA), and the Institut Pasteur (Paris, France). ABIVAX intends to pursue further business development opportunities to access commercial products as part of its overall corporate strategy.

ABIVAX was founded by Dr. Philippe Pouletty, M.D., managing partner at Truffle Capital, the cornerstone investor in ABIVAX since its creation. The company is listed on the regulated market of Euronext Paris, compartment B (ISIN code: FR0012333284 – Ticker: ABVX). For more information, please visit www.abivax.com.

Follow us on Twitter @ABIVAX_


Prof. Hartmut J. Ehrlich, M.D., CEO of ABIVA
Investor relations
Raquel Lizarraga
+33 1 53 83 06 93
Press relations
Caroline Carmagnol and Florence Portejoie
+33 6 64 18 99 59 / +33 1 44 54 36 64

Source:  http://www.businesswire.com/news/home/20150924006176/en/ABIVAX-Completes-Recruitment-Phase-IIbIII-Pivotal-Study#.VgS5ICu1VVo

Monday, September 21, 2015

Liver injury more frequent among chronic HBV with normal, minimally high ALT

Researchers found that Chinese patients with chronic hepatitis B virus infection with persistent normal or minimally elevated alanine aminotransferase more frequently developed liver injury, such as fibrosis or necroinflammation, and may need increased surveillance

“In this study, we present our analysis of liver histology in a large cohort of Chinese chronic hepatitis B patients with [persistent normal] ALT or minimally elevated ALT,” the researchers wrote. “Our analysis was focused on investigating mechanisms underlying normal or nearly normal alanine aminotransferase under conditions of liver injury and fibrosis.”

“The fibrosis detected in the late HBeAg or in HBeAg-negative phase was possibly carried over from an early HBeAg phase, supporting therapeutic intervention in early HBeAg positive patients, as a priority. Lowering ALT [upper limit of normal] and increasing the frequency of ALT testing are recommended for management of patients with transiently elevated ALT.” – by Melinda Stevens

Read more... 

U.S. Food and Drug Administration Grants Fast Track Designation to Can-Fite's CF102 in the Treatment of Liver Cancer

PETACH TIKVA, Israel, Sept. 17, 2015 /PRNewswire/ -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, today announced the U.S. Food and Drug Administration (FDA) has granted the Company's drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer. CF102 had already received the FDA's Orphan Drug designation.

Can-Fite is currently conducting a Phase II study for this indication in the U.S., Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar® (sorafenib). Patients are treated twice daily with 25 mg of oral CF102, which has been found to be the most efficacious dose in Can-Fite's earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.

Fast Track, aimed at getting important new drugs that meet an unmet need to patients earlier, is expected to expedite the development of CF102. Drugs that receive Fast Track designation benefit from more frequent meetings and communications with the FDA to review the drug's development plan to support approval. It also allows the Company to submit parts of the New Drug Application (NDA) on a rolling basis for review as data becomes available. Since the Fast Track Program started, from March 1998 through June 30, 2015 a total of 318 Fast Track applications have been received by the FDA. The FDA has granted 202 of them, and denied 110, with 6 more pending.

"We are very pleased that the FDA recognizes the potential for CF102 to treat HCC patients who have tried, and not been responsive to Nexavar, the only FDA approved drug currently on the market for this indication," stated Can-Fite CEO Dr. Pnina Fishman. "We consider Fast Track designation to be a major catalyst for our CF102 development program and we believe it could shorten our time to market for CF102, thereby making a considerable difference for patients."

According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar® annual sales, as reported by Bayer, were €773 million in 2014.

About CF102 
CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite's pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.

About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company is preparing for a Phase III CF101 trial for rheumatoid arthritis and is preparing its protocol for its next advanced psoriasis clinical trial. Can-Fite's liver cancer drug CF102 is in Phase II trials and has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration. CF102 has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. The Company's CF602 has shown efficacy in the treatment of erectile dysfunction. Can-Fite has initiated a full pre-clinical program for CF602 in preparation for filing an IND with the U.S. FDA in this indication. These drugs have an excellent safety profile with experience in over 1,200 patients in clinical studies to date. For more information please visit: www.can-fite.com.