Roth Capital Positive on BioLineRx (BLRX) Following BL-8040 Phase 2b Initiation

Roth Capital affirms BioLineRx (Nasdaq: BLRX) with a Buy rating and $7 price target after the company announced the initiation of a Phase 2b trial for BL-8040 as a novel consolidation treatment for acute myeloid leukemia (AML).

Analyst Joseph Pantginis noted, This study is an important first step in the development of BL-8040 and the planned broadening of its profile, in our belief. The rationale for this study comes from clinical and preclinical data showing that BL-8040 has a dual MOA: a) mobilizing leukemic blasts out of BM thereby exposing them to cytotoxic agents and b) direct induction of apoptosis in leukemic blasts. This study will assess whether BL-8040 can prevent or reduce relapse. MRD in BM is thought to contribute to relapse of AML in patients who achieved CR following induction therapy, thereby necessitating consolidation therapy. Recall that this is the first of three studies expected this year, the other two being in Flt3-ITD AML patients and in hypoplastic MDS and aplastic anemia patients. Both studies will be done in collaboration with MD Anderson. The next clinical milestone for this program will be the expected release of topline data in 4Q15 from the PhII study in r/r AML. We expect to receive an update about the Type B meeting with FDA regarding the planned Phase II study of BL-8040 in stem cell mobilization. Recall that Phase I study in healthy volunteers met all safety and efficacy endpoints. We believe these data represent important proof of concept demonstrating BL-8040's efficacy in mobilizing SC as well as its differentiating characteristics from current SC mobilization procedure with GCSF and Mozobil.

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