BioLineRx 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.
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.
BioLineRx also recently announced an agreement with Biokine Therapeutics Ltd., a Clal Biotechnology Industries portfolio company, for the development and commercialization of BL-8040, a Phase II
BL-8040 is a short peptide that functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis (growth of new blood vessels in the tumor), metastasis (spread of the disease to other organs or organ parts) and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a Phase I/II, open-label, dose escalation, safety and efficacy clinical trial in 16 multiple myeloma patients, BL-8040 demonstrated an excellent safety profile and was well tolerated at all doses tested. On the basis of data obtained from this study, the FDA has approved an IND application.
BL-8040 has been shown to induce the mobilization of healthy hematopoietic stem cells from the bone marrow into the peripheral blood. BL-8040 also mobilizes cancer cells from the bone marrow and other sites and may therefore expose these cells to chemo- and bio-based anti-cancer therapy and induce apoptosis (cell death). Pre-clinical studies show that BL-8040 is efficient, both alone and in combination with the anti-cancer drug Rituximab, in reducing bone marrow metastasis of lymphoma cells and stimulating lymphoma cell death.
A Phase II clinical study for evaluating BL-8040’s efficacy on AML patients is expected to commence in the first half of 2013.