BioLineRx reports Q2 ; Phase 2 BL-8040 data for AML in Q4; meeting with FDA in October to discuss BL-8040 for stem cell mobilization treatment
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7:11 AM ET 8/20/15 | Briefing.com
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Q2 EPS ($0.09) vs. ($0.12) last year. "We expect some very exciting milestones for our BL-8040 oncology platform in the coming few months. First, we expect to report top-line data, including response rates, from our Phase 2 clinical study for treating relapsed/refractory AML in the fourth quarter of 2015, following the highly encouraging results to date we reported from the dose escalation stage of this study. Additionally, we presented positive safety and efficacy results from our Phase 1 study of BL-8040 as a novel stem cell mobilization treatment at the European Hematology Association conference in June, which supported the use of BL-8040 as a single-agent, single-injection, one-day regimen for the collection and transplantation of stem cells. This is a major improvement over currently available procedures, and the superior composition of the collected cells may offer the potential for better quality grafts and improved transplant outcomes. We look forward to meeting with the FDA in October to discuss the next steps in the clinical development of this program. Based on the outcome of the meeting, we would expect to initiate a Phase 2 study as early as the first quarter of 2016."
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