Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and finally, a response from the regulatory agency regarding the approval status.
Earlier this week, BioLineRx Ltd. (BLRX) announced that the Israeli Ministry of Health informed the company that it can start a phase I study on its oncology candidate, BL-8040. BioLineRx is developing BL-8040 for the mobilization of stem cells from the bone marrow to the peripheral blood circulation, which could enable their collection for subsequent autologous or allogeneic transplantation.
The phase I study will consist of two parts. BioLineRx intends to initiate the study in the third quarter of 2014.
The randomized, double-blind, placebo-controlled dose escalation part I of the study will evaluate the safety and tolerability of escalating repeated doses of BL-8040 in 8 healthy volunteers. The mobilization capacity of one or two injections of BL-8040 will be assessed as a stand-alone therapy along with the evaluation of the pharmacokinetic profile of the candidate. If successfully developed and commercialized, such a therapy will decrease treatment costs significantly.
BioLineRx said that based on the part I results, it will select the optimal safe and efficacious dose of BL-8040 for the part II phase of the study. Part II will be an open-label study evaluating BL-8040’s stem cell mobilization capacity and the yield of cells collected by apheresis in 8 healthy volunteers.
Meanwhile, BioLineRx is evaluating BL-8040 for relapsed and refractory acute myeloid leukemia. Results from a phase II study should be out in early 2015. BioLineRx expects to initiate an investigator-led phase I/II study for the treatment of chronic myeloid leukemia this year.
Investors looking for well-positioned stocks in the biopharma sector may consider Gilead Sciences Inc. (GILD), Regeneron Pharmaceuticals, Inc. (REGN) and ARIAD Pharmaceuticals, Inc. (ARIA). While Gilead and Regeneron carry a Zacks Rank #1 (Strong Buy), ARIAD holds a Zacks Rank #2 (Buy).
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