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.