Clinical Trials

Date: 2012-06-25

Type of information:

phase: 2

Announcement: • announcement of an oral presentation at the 14th International Symposium on Viral Hepatitis and Liver Disease (ISVHLD)
The abstracts are entitled \"Aggregate report on safety and efficacy of a new sustained release IFN (IFN XL) as compared to standard of care\" and \"Medusa formulated Interferon-alpha-2b Shows a Favorable Efficacy / Tolerability Profile vs. PEGylated IFN-alpha-2b in Hepatitis C Patients in the Phase 2 Study ANRS HC23 COAT-IFN.\" The abstracts have been presented by Professor Christian Trepo of Hôpital de la Croix Rousse, Lyon, France, and Roger Kravtzoff, Preclinical and Clinical Director at Flamel Technologies
• completion of patient recruitment

Company: Flamel Technologies (France)

Product: IFN-alpha-2b XL

Action mechanism: IFN-alpha-2b XL is a new formulation of recombinant Interferon alpha-2b based on Flamel\'s proprietary Medusa hydrogel delivery system. Medusa is a versatile biodegradable carrier for the development of a wide range of novel and second-generation long-acting protein and peptide products. IFN-alpha-2b XL is designed to provide patients with a longer acting and more tolerable approach to interferon therapy compared with approved interferon regimens.

Disease: chronic hepatitis C

Therapeutic area: Infectious diseases

Country: France

Trial details: 84 HCV patients have been treated in the on-going Phase 2 clinical study, randomized, three parallel-arm, comparative, open-label, multi-center study and were allocated to either IFN-a-2b XL, or PegIntron 1.5 µg/Kg, both in combination with weight based ribavirin.
Patients were each injected over a twelve-week period to compare the therapeutic potential and safety of IFN-a2b XL versus PegIntron in patients with chronic hepatitis C virus (HCV) infection (genotypes 1 and 4). This study was conducted on both naïve and non-responder patients.
This Phase 2 clinical study is sponsored by Inserm-ANRS (French National Institute of Health and Medical Research -- French National Agency for Research on AIDS and Viral Hepatitis).

Latest news: Flamel Technologies has announced that its Medusa-formulated interferon-alpha (\"IFN a-2b XL\") was featured in a lecture and an oral presentation on June 25 at the 14th International Symposium on Viral Hepatitis and Liver Disease (ISVHLD) held in Shanghai, China.
The abstracts presented the background, rationale and design of the on-going studies which are evaluating the therapeutic potential and safety of Flamel\'s Medusa-formulated IFN a-2b XL, a long acting, unmodified (in contrast to PEGylated interferons), fully active interferon injected once weekly in patients with chronic hepatitis C virus infection. In the Phase 2 clinical study, the Medusa-formulated IFNa-2bXL at 27MIU has demonstrated a remarkably consistent safety profile across all available data. Improved tolerability of IFNa-2bXL was obtained in addition to good efficacy since the antiviral activity of IFNa-2bXL appears at least similar to that of reference Peg-IFNa-2b in a 3-month course of combined therapy ( See
The available study data confirms the results obtained from previous clinical studies, indicating an improved tolerability of Medusa-formulated IFNa-2bXL at 27MIU compared to PegIntron. No serious adverse events were reported as definitely or probably attributable to Medusa-formulated IFN a-2b XL.
In addition, Flamel Technologies announced that it has reached its enrollment objective of 84 patients in its ongoing Phase 2 clinical study: ANRS HC23 COAT-IFN.

Is general: Yes