BioLineRx Receives Approval From French Regulatory Authorities To Commence A Phase I/II Clinical Trial For BL-8020, An Oral, Interferon-Free Treatment For Hepatitis C

BioLineRx (NASDAQ:BLRX)(TASE:BLRX), a biopharmaceutical development company, announced today 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). 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 and will include HCV-infected patients of any genotype who have previously failed or relapsed following treatment with the standard-of-care.

“We are excited about the upcoming initiation of clinical trials for our first anti-HCV agent, BL-8020. The Phase I/II trial will be led by Prof. Stanislas Pol, M.D., Ph.D, from Hôpital Cochin in Paris, and Prof. Marc Bourliere, M.D., from Hôpital Saint Joseph in Marseille, both prominent international leaders in the HCV field,” stated Dr. Kinneret Savitsky, CEO of BioLineRx. “Based on BL-8020’s pre-clinical results, its unique mechanism of action and synergistic effect, we have high hopes for this drug especially when combined with other available Hepatitis C drugs. We look forward to the interim results from the Phase I/II trial expected towards the end of 2013.”

BL-8020 is an orally available HCV treatment with a unique mechanism of action, as compared to other currently used anti-HCV agents. This suggests pan-genotypic efficacy and the ability to be combined with other HCV therapeutics as part of an interferon-free regimen. 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.

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.

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