Thursday, February 26, 2015

ABIVAX Recruits First Patient in a Pivotal Phase IIb/III Clinical Trial with ABX203, a Novel Immunotherapy Against Chronic Hepatitis B

PARIS, February 26, 2015 /PRNewswire/ --

ABIVAX, a clinical stage biotech company developing and commercialising anti-viral compounds and human vaccines, today announced that it has dosed in New Zealand the first patient in a Phase IIb/III clinical trial of ABX203 which is taking place in several countries of the Asia-Pacific region. The study is designed to assess whether ABX203 can deliver a significant improvement in the treatment of chronic hepatitis B (CHB) via controlling viral load for a much longer period of time when compared to current treatment options.

ABX203 is a therapeutic vaccine composed of 2 recombinant proteins from HBV, the surface antigen (HBsAg) and the nucleocapsid (core) structure (HBcAg). ABX203 has been designed to induce the production of neutralizing serum antibodies to HBsAg and the induction of strong cellular responses which are 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 distribution rights for ABX203 for more than 80 territories in Asia, Europe and Africa. They 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 CIGB in Cuba and Bangladesh. 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.

Professor Christian Trepo, MD, one of the top hepatitis experts worldwide, commented: "The previous studies of ABX203 have provided clinical proof of the concept of therapeutic vaccination in chronic hepatitis B. Its unique sustained effect, in addition to a shorter duration of administration, means that ABX203 could deliver important therapeutic advantages over standard treatments for patients suffering from chronic hepatitis B."

The pivotal Phase IIb-III study is expected to be conducted at 50 clinical centres in 7 countries in the Asia-Pacific region. The study aims to recruit approximately 230 patients with HBeAg negative active chronic hepatitis B.

In this large scale study a group of patients will receive ABX203 for 24 weeks on top of their NUCs therapy (current standard of care together with PEG-IFNα) and these patients will be evaluated against a control group receiving only NUCs. The study will assess the following objectives at week 48 - 24 weeks after treatment with ABX203 has completed:
  • Characterization of the level of sustained control of Hepatitis B disease following cessation of treatment with NUCs
  • Assessment of safety and reactogenicity of ABX203
  • Characterization of the antibody and cellular immune responses to ABX203
The results from this Phase IIb-III study are expected in Q3 2016. A positive outcome from this study is expected to allow ABIVAX to file for marketing approval in certain Asian countries.

Professor Hartmut Ehrlich, M.D., CEO of ABIVAX, said: "We are confident that ABX203, our therapeutic vaccine against chronic hepatitis B could be a major progress in the treatment of patients with this devastating disease. This pivotal Phase IIb-III study that we have announced today is designed to confirm that ABX203 can deliver meaningful clinical benefits in terms of long-term viral control, a goal that cannot be achieved today with the current standard of care."

Gerardo Guillen, PhD, head of R&D at CIGB in Havana, commented: "This first-in class therapeutic vaccine is awaiting market approval in Cuba and we are very pleased to see the great progress our partner Abivax is making with the international development of this world leading immunotherapeutic to treat chronic hepatitis B."

About Chronic Hepatitis 
Hepatitis B virus (HBV) infection is a major public health problem worldwide. Infection with HBV causes a broad spectrum of liver disease, including subclinical infection, acute self-limited hepatitis, and fulminant hepatitis. Persons infected with HBV can also develop persistent infection, which can lead to chronic disease and death from cirrhosis or hepatocellular carcinoma (HCC).

According to the World Health Organization (WHO), an estimated 2 billion persons worldwide have been infected with HBV, and more than 350 million persons, or 5% of the world's population, have chronic, lifelong infections. HBV infection is an established cause of acute and chronic hepatitis, cirrhosis, liver failure and liver cancer. It is the cause of up to 80% of hepatocellular carcinomas.  Around 1 to 1.5 million people die every year due to the consequences of hepatitis B.
With nearly 200 million people with chronic HBV, South-East Asia and the Pacific Regions account for ¼ of the world population and bears 30% of world's total disease burden.

About ABIVAX 
ABIVAX is an advanced clinical stage biotech company focused on becoming a global leader in the discovery, development and commercialization of anti-viral compounds and human vaccines to treat some of the world's most important 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.
For more information, please visit the company's website: http://www.ABIVAX.com

Contacts 
ABIVAX
Prof. Hartmut J. Ehrlich, CEO
Press Relations
Citigate Dewe Rogerson
David Dible
david.dible@citigatedr.co.uk
+44(0)20-7282-2949
ALIZE RP
Caroline Carmagnol et Valentine Boivin
abivax@alizerp.com
+33-1-44-54-36-63 / +33-6-64-18-99-59



SOURCE ABIVAX

Wednesday, February 18, 2015

TDF monotherapy ‘reasonable’ option in entecavir-resistant HBV

Researchers from the Republic of Korea have found that the efficacy of tenofovir disoproxil fumarate (TDF) monotherapy is comparable to that of TDF plus entecavir in chronic hepatitis B (CHB) patients with genotypic resistance to entecavir.

The primary endpoint of virological response, defined as serum levels of hepatitis B virus (HBV) DNA of less than 15 IU/mL at week 48, was achieved by 71.1% of 45 CHB patients harbouring at least one entecavir-resistance mutation who were randomly assigned to receive open-label TDF alone. This did not differ significantly from the 73.3% response rate in the 45 patients treated with TDF plus entecavir.

The researchers point out, however, that the increase in the proportion of patients exhibiting a response was “blunted” from week 24 to 48, raising concerns regarding the effect of prolonging therapy on the rate of virological response.

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IL-23 predicts PegIFN response in chronic HBV

High baseline serum levels of interleukin (IL)-23 can help to identify hepatitis B e antigen (HBeAg)-positive chronic hepatitis B patients who are likely to respond to pegylated interferon (PegIFN) treatment, a Chinese study indicates.

Baseline serum levels of the cytokines IL-23 and IL-17, which the researchers explain are implicated in the development of chronic inflammation in chronic hepatitis B patients, were significantly higher in the 72 HBeAg-positive chronic HBV patients than in the 55 HBeAg-negative patients.

After a 48-week course of PegIFN-α treatment and a follow-up period of equal length, 42 HBeAg-positive patients achieved HBeAg clearance and 40 showed a reduction in hepatitis B surface antigen (HBsAg) levels of greater than 1 log10IU/mL.

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Monday, February 16, 2015

HCC incidence occurred in patients undergoing monotherapy for HBV

In a retrospective cohort study, incidence of hepatocellular carcinoma occurred over time among adults with chronic hepatitis B virus infection being treated with entecavir or tenofovir, according to study data.

“In particular, long-term monotherapy with one of the current first-line nucleoside analogues, entecavir or tenofovir disoproxil fumarate, results in maintained virological remission in [greater than] 95% of patients, often achieves regression of the histological lesions of cirrhosis and prevents or reverses hepatic decompensation,” the researchers wrote. “However, hepatocellular carcinoma may still develop in chronic hepatitis B patients, particularly those with cirrhosis, even when they achieve maintained virological remission under long-term therapy with [nucleoside analogues].”

“The findings of this large multicenter retrospective study in Caucasian patients with [chronic HBV] indicate that HCC may still develop under effective long-term [entecavir] or [tenofovir] therapy, with the HCC risk being higher in patients with more advanced liver disease,” the researchers wrote.

Papatheodoridis GV, et al. J Hepatol. 2015;doi:10.1016/j.jhep.2014.08.045.

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Tuesday, February 10, 2015

Arrowhead Submits Amended Protocol for HBV Trial; Prepares Next Rx Candidate

NEW YORK (GenomeWeb) – Officials from Arrowhead Research disclosed this week that it has submitted to the US Food and Drug Administration an amended protocol for a planned Phase IIb trial of its siRNA-based hepatitis B therapy ARC-520, which the agency had put on partial hold amid concerns about the size of doses being tested.

According to COO Bruce Given, the company does not expect the changes to impact the overall timing of the company's ARC-520 development strategy, which includes planned clinical trials in Europe and Asia. However, speaking during a conference call held to discuss Arrowhead's fiscal first quarter financial results, he stressed that the firm will not go forward with its US trial "until the FDA has blessed the new design."

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Saturday, February 7, 2015

Advancing the Treatment and Prevention of Hepatitis B and C

Subtitle: National APAMSA Hepatitis B and Conference – November 2014

BOSTON, MA — On Saturday, November 8, 2014, the Asian Pacific American Medical Student Association (APAMSA) hosted its annual National APAMSA Hepatitis B and C Conference featuring some of the world’s leading hepatologists. Through a series of lectures and a research poster session, the annual conference seeks to inform medical and premedical students about the current developments in Hepatitis B&C treatment and prevention. A physician-student mentorship luncheon session also presents additional opportunities for conference attendees to engage in discussions about Hepatitis B and C outreach efforts in their local communities.
With over 2 billion people in world affected by HBV in the past and present, and with 15-40% those cases developing liver cirrhosis, liver disease, or liver cancer, we really have the opportunity to have a global impact in treating this disease.
                                                                                                                                             – Dr. Daryl Lau

Although Hepatitis B (HBV) and Hepatitis C (HCV) are not identical viruses, they are transmitted through similar methods and both are among the leading causes of liver cancer in the world. HBV and HCV are commonly referred to as the “silent killers” because infected patients can remain asymptomatic for many years and may not experience symptoms until the infection has progressed to chronic stages, resulting in severe liver disease or cancer. Therefore, those infected can unknowingly transmit the virus to others. Over one million people in the world die each year from HBV and HCV liver associated diseases. Furthermore, since both are transmitted by blood and blood-derived bodily fluids, there are concerns about the potential of mother-to-child vertical transmission.

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Australia: 5 Facts About Liver Cancer, Australia’s Deadliest

Liver cancer, the growth of tumors in the liver, is among the common cancers with over 700,000 new cases reported in one year alone. The major reason for the incidence of this dreadful cancer is identified as liver infection of Hepatitis B or C virus. A scary finding by Hepatitis Australia shows that for every person dying of liver cancer in Australia, there is a new person diagnosed with the disease. With cases that lead to death increasing in an alarming rate, medical world is taking more efforts to tackle this disease. Here is a look at some of the facts about liver cancer.

Prevalence is more among men and old people: Liver cancer is observed to be more prevalent in men than in women, and it tends to be found more in old people. More than 80% of all reported liver cancer cases are in developing countries in Asia and Africa.

One of the major causes is Hepatitis infection: Cirrhosis, where scar tissues replace healthy tissues in the liver, is considered as one of the major causes of liver cancer. This is brought about by chronic alcohol use, persistent viral infections, and certain auto immune diseases. Long term hepatitis B infection (often undetected) is cited as a major cause of cirrhosis by experts. A lot of liver cancer cases are due to smoking, diabetes and obesity.  Exposure to aflatoxins, arsenic, vinyl chloride, etc are also considered as potent causes for the disease.

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