BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that it has successfully completed the pre-clinical development of BL-8020, an orally available, interferon-free treatment for the Hepatitis C virus (HCV), 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 is an orally available HCV treatment with a unique mechanism of action, as compared to other currently used anti-HCV agents, which 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 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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