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news.Tekmira Pharmaceuticals says its partner Hana Biosciences has commenced patient enrollment in a Phase II clinical trial evaluating Marqibo as a treatment for relapsed acute lymphoblastic leukemia.
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Hana Biosciences is developing and commercializing Marqibo under a licensing partnership agreement with Tekmira. Hana Biosciences is paying development costs and will also pay milestones to Tekmira based on progress and royalties based on sales.
The primary objective of the study is to assess the efficacy and tolerability of weekly doses of Marqibo as a single agent without dose capping, measured by complete response (CR) rate or complete response without full platelet recovery (CRp).
Secondary objectives include evaluation of safety, duration of CR/CRp, and survival. The patient population is defined as Philadelphia chromosome-negative adult patients in second relapse, or those patients who relapsed following two lines of anti-leukemia chemotherapy, including those who have previously undergone stem cell transplantation. In this trial Hana expects to enroll up to 56 patients.
Tim Ruane, president and CEO of Tekmira, said, “This Phase II trial is an important development for Tekmira because it is the first of several steps that Hana Biosciences is taking in 2007 to advance products licensed from Tekmira in 2006. We are pleased with Hana’s clinical development strategy for these products and their ability to execute and advance products through development.”