Title: Hana Biosciences Presents Marqibo Data At the 49th Annual Meeting of the American Society of Hematology Date: 12/8/2007 9:00:00 AM
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SOUTH SAN FRANCISCO, Calif., Dec. 8, 2007 (PRIME NEWSWIRE) -- Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, presented results today from both clinical and non-clinical studies of Marqibo(r) (vincristine sulfate injection, OPTISOME(tm)) at the 49th Annual Meeting of the American Society of Hematology (ASH). In an oral session, Deborah A. Thomas, M.D. from the University of Texas M. D. Anderson Cancer Center presented clinical data showing that Marqibo with or without pulse dexamethasone appears to have clinically meaningful activity in heavily pre-treated adults with Acute Lymphoblastic Leukemia (ALL).
Dr. Thomas presented publication No. 858, "Safety and Efficacy of Marqibo (Vincristine Sulfate Liposomes Injection, OPTISOME(tm)) for the Treatment of Adults with Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)." during the session entitled Acute Lymphocytic Leukemias: Therapy, excluding Transplantation.
Data from two clinical trials were integrated for the presentation: a Phase 2 trial of single agent Marqibo given at 2 mg/m2 (no dose capping) every two weeks; and a multi-center dose-escalation Phase 1 trial of Marqibo in combination with pulse dexamethasone administered on a weekly schedule. In total, 52 adult patients with relapsed or refractory ALL were treated in the two studies combined, and all patients had previously received and failed conventional vincristine containing therapy. There were no restrictions on the number of prior therapies. Out of the 52 patients, eight complete remissions and three partial remissions were observed for an overall response rate of 21 percent. An additional 12 patients (23 percent) achieved hematological improvements such as clearance of marrow blasts and platelet transfusion independence. Five responders were able to undergo allogeneic stem cell transplantation following therapy with Marqibo. The maximum-tolerated dose was established in the Phase 1 trial as 2.25 mg/m2 without dose-capping.
"The data presented today by Dr. Thomas provides support and validation for our ongoing rALLy study, a Phase 2 registration-enabling clinical trial of single-agent Marqibo in adults with ALL in second relapse," stated Steven R. Deitcher, M.D., President and CEO of Hana Biosciences. "Marqibo has demonstrated clinical benefit among an extremely sick patient population for whom there is no approved treatment regimen. We are pleased to be working with outstanding clinical investigators to advance this promising new agent."
Hana Biosciences also presented non-clinical data for Marqibo during the Lymphoma: Pre-Clinical: Chemotherapy and Biologic session under publication No. 1403, "Marqibo (Vincristine Sulfate Liposomes Injection, OPTISOME(tm)) Concentrates Vincristine in Tumor Tissue and Lymphoid Malignancy Oriented Tissues in Tumor-Bearing Mice." The study showed that Marqibo's Optisome(tm)-encapsulation of vincristine resulted in targeted delivery and concentration of vincristine in tumor tissue, bone marrow, lymph nodes, liver and spleen, and maintenance of significant tissue drug concentrations for an extended period of time compared to conventional vincristine. Specifically, lymphoid malignancy-oriented tissue and intra-tumor vincristine concentrations were greater in Marqibo-treated mice compared to conventional vincristine-treated mice resulting in greater vincristine exposure. Marqibo administration resulted in a three-fold increased concentration of vincristine in bone marrow at 48 hours and maintained significant tissue concentrations for several days compared to conventional vincristine. The ability of Marqibo to target these tissues and organs makes it particularly attractive as a treatment for hematologic malignancies such as leukemia, myeloma and lymphoma.
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