BioLineRx (BLRX) announced that Prof. Arnon Nagler (Director of the Hematology Division and Bone Marrow Transplantation Center) was given the final regulatory approval to evaluate its oncology candidate BL-8040 in a phase I/II study for the treatment of chronic myeloid leukemia (CML).
The randomized, dose-escalation study is designed to assess the combination of BL-8040 and Novartis’ (NVS) Gleevec for improving the response of CML patients in the first chronic phase of the disease who have achieved a less than optimal response with Gleevec alone.
The primary endpoint of the study is the safety and tolerability of BL-8040 in combination with Gleevec, while secondary endpoints include assessing the efficacy of the combination therapy in achieving improved cytogenetic and molecular response.
The preclinical data which was out in Feb 2014 showed that treatment with BL-8040 directly suppressed cancer cell growth. BL-8040 was also effective in sensitizing CML cells that hide in the bone marrow to therapy-induced apoptosis. The study concluded that BL-8040 has the potential to treat CML patients who have developed resistance to Gleevec.
We note that BioLineRx is also evaluating BL-8040 for the treatment of acute myeloid leukemia (AML) in a phase II trial. The results are expected at the end of 2014 or early 2015. BL-8040 is also being evaluated in phase I for stem cell mobilization. This trial is expected to start in the first half of 2014 with results expected in the second half of 2014.
The U.S. Food and Drug Administration granted an orphan drug designation to BL-8040 for the treatment of stem cell mobilization and AML.
BioLineRx carries a Zacks Rank #3 (Hold). We expect investor focus to remain on the development of BL-8040 in all three studies.
Investors looking for better-ranked stocks in the biopharma sector may consider companies like Shire (SHPG) and Alexion Pharmaceuticals, Inc. (ALXN). Both stocks carry a Zacks Rank #2 (Buy).
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