Date: 2013-04-29
Type of information: Initiation of patient enrollment
phase: 1-2
Announcement: enrollment of the first patient
Company: BiolineRx (Israel)
Product: BL-8020
Action
mechanism: BL-8020 is a proprietary fixed-dose combination treatment composed of Ribavirin and Hydroxychloroquine (HCQ), which results in an improved version of Ribavirin. BL-8020’s mechanism of action involves the inhibition of HCV-induced autophagy in the host cells. Autophagy is a mechanism by which cells degrade damaged or unnecessary cellular components, including invading viruses. However, HCV has found a way to take advantage of this mechanism in order to replicate inside the cell. By inhibiting this mechanism, BL-8020 reduces the ability of HCV to replicate.
Disease: hepatitis C
Therapeutic area: Infectious diseases
Country: France
Trial
details: The study is an open-label trial to evaluate the efficacy, safety and tolerability of BL-8020 in patients infected with HCV. It will be conducted at two clinical sites in France (Hopital Cochin - Paris and Hopital Saint-Joseph - Marseille) and will include up to 32 HCV-infected patients of any genotype who have previously failed or relapsed following treatment with the standard-of-care. The primary endpoint of the study is to evaluate the effect of a 16-week combination therapy with Ribavirin and HCQ. The study is specifically designed to allow intra-subject analysis, in order to determine the extent to which HCQ enhances Ribavirin’s antiviral activity.
Latest
news: * On April 29, 2013, BioLineRx, a biopharmaceutical development company, has announced enrollment of the first patient in a Phase I/II trial for BL-8020, an orally available, interferon-free treatment for the Hepatitis C virus (HCV). The patient was enrolled at the Hôpital Cochin in Paris, France. The study is specifically designed to allow intra-subject analysis, in order to determine the extent to which HCQ enhances Ribavirin’s antiviral activity. BL-8020’s safety and efficacy have been demonstrated in a number of pre-clinical studies. These studies have shown that BL-8020 has a synergistic effect with other anti-HCV agents. This effect on other therapies is likely to increase their potency and reduce the numerous adverse effects often associated with these drugs by enabling utilization of lower dosages. The use of multiple therapies with different modes of action is also likely to be beneficial for patients who have developed resistance or do not respond to current treatments and is a common practice in current HCV treatment regimens. BiolineRx looks forward to the partial results from the Phase I/II trial expected towards the end of 2013.
* On March 13, 2013, BioLineRx, a biopharmaceutical development company, has announced that it has received approval from the French regulatory authorities to commence a Phase I/II trial for BL-8020, an orally available, interferon-free treatment for the Hepatitis C virus (HCV). BL-8020’s safety and efficacy have been demonstrated in a number of pre-clinical studies. These studies have shown that BL-8020 has a synergistic effect with other anti-HCV agents. This effect on other therapies is likely to increase their potency and reduce the numerous adverse effects often associated with these drugs by enabling utilization of lower dosages. In addition BL-8020 may reduce therapy duration. The use of multiple therapies with different mechanisms is also likely to be beneficial for patients who have developed resistance or do not respond to current treatments and is a common practice in current HCV treatment regimens.
* On October 16, 2012, BioLineRx has announced that it has successfully completed the pre-clinical development of BL-8020, and plans to commence a Phase I/II safety and efficacy study for BL-8020 in Europe during the first quarter of 2013. Since in-licensing BL-8020 in January 2012, BioLineRx has successfully completed a number of pre-clinical studies with the therapy. The data package is now ready for the regulatory submissions required to begin the clinical phase of development. BioLineRx is currently engaged in the regulatory submission process and expects to receive approval from the regulatory authorities by the end of this year.
BL-8020 was licensed under a worldwide, exclusive agreement from Genoscience, a French company focused on viral disease therapeutics. It was developed as an anti-viral therapy by Professor Philippe Halfon, Co-Founder and President of Genoscience and a world-renowned scientist for his work on HIV, HPV (human papilloma virus causing cervical cancer) and Hepatitis.
