Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Earlier this week, BioLineRx Ltd. (BLRX) announced that it has completed the dose-escalation stage in a phase I study on BL-8040. The company is developing BL-8040 as a treatment for the mobilization of stem cells from bone marrow to the peripheral blood circulation.
The phase I study is being conducted in two parts. The first part, which is a randomized, double-blind, placebo-controlled dose-escalation study, is evaluating the safety and tolerability of escalating repeated doses of BL-8040 in healthy volunteers. The latter part will be an open-label study in which BL-8040’s stem cell mobilization capacity and yield of cells collected by apheresis will be evaluated.
BioLineRx said that BL-8040, if successfully developed, can shorten the duration of treatment significantly and reduce the costs associated with it apart from eliminating the painful side effects of mobilizing stem cells from the bone marrow using granulocyte colony-stimulating factor. Results from this study should be out in the first quarter of 2015.
Meanwhile, BioLineRx is evaluating BL-8040 in a phase II study for the treatment of relapsed and refractory acute myeloid leukemia (AML). Results from this study should be out in the second half 2015. In Dec 2014, the company reported that BL-8040 had led to considerable mobilization of AML cancer cells from the bone marrow to peripheral blood with robust apoptosis of these cells. The candidate also demonstrated safety and tolerability among the patients.
The company is also planning to initiate additional studies on BL-8040 in three new indications in 2015.
Additionally, BioLineRx is developing its immunology candidate, BL-7010 for the treatment of celiac disease. At the time of announcing its third-quarter 2014 results, the company announced its plans to commence the first efficacy study on BL-7010 in the second half of 2015.
We expect investor focus on pipeline updates from the company.
BioLineRx carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Biodel Inc. (BIOD), Apricus Biosciences, Inc. (APRI) and Shire plc (SHPG). All these stocks carry a Zacks Rank #1 (Strong Buy).
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