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.
About Marqibo(r) (vincristine sulfate injection, OPTISOME(tm))
Marqibo has received U.S. Food and Drug Administration (FDA) Orphan Drug designation and Fast Track Status in adult ALL. Marqibo is currently enrolling patients in the rALLy study, a registration-enabling clinical trial in relapsed ALL. A pilot Phase 2 clinical trial in metastatic uveal melanoma is also currently enrolling patients. A Phase 3 trial in front-line elderly ALL is planned for 2008.
Marqibo, a novel, targeted, Optisomal formulation of vincristine, has shown promising anti-cancer activity in patients with acute lymphoblastic leukemia, non-Hodgkin's lymphoma and melanoma in several clinical trials. Vincristine is FDA-approved as a single agent and in combination regimens for the treatment of hematologic malignancies such as lymphomas and leukemias. Vincristine, a microtubule inhibitor, kills cancer cells when they enter a very specific point in the cell cycle, and its efficacy is concentration- and exposure duration-dependent. Marqibo is believed to extend the circulation time of vincristine in the bloodstream, increase targeting of the drug to malignant cells, and enhance exposure duration at the site of the disease. Unlike regular vincristine, Marqibo is dosed based on patient body surface area without the need to limit the dose to avoid neurotoxicities.
About OPTISOME(tm) Nanoparticle Technology
Optisomes are a new generation of unique sphingomyelin/cholesterol-based nanoparticles designed to encapsulate cell cycle-specific chemotherapeutics designed for improved efficacy with reduced toxicity. Optisomes are approximately 100 nanometers in diameter and able to encapsulate and transport cancer drugs preferentially to tumor sites. While too large to easily migrate out of normal blood vessels, Optisomes are able to migrate across the more "leaky" vasculature of a tumor, resulting in higher concentrations of drugs at tumor sites than in normal tissue. Optisomes' unique sphingomyelin-cholesterol composition is particularly well suited to cell cycle-specific agents such as vincristine, vinorelbine and topotecan. The relative rigidity of the Optisomes' outer shell results in a long circulating half-life and sustained drug release at the tumor site, which may increase tumor cell exposure during the most vulnerable phases of cell division. Combined, these factors are key to the Optisome advantage as sustained drug exposure increases tumor cell death. Hana's Optisome pipeline includes Marqibo(r) (vincristine), Alocrest(tm) (vinorelbine) and Brakiva(tm) (topotecan).
About Acute Lymphoblastic Leukemia
Approximately 4,000 cases of ALL are diagnosed annually in the United States. While cure rates for childhood ALL have steadily improved to nearly 90 percent, adult ALL reported cure rates seldom exceed 40 percent. The poorer outcome in adult ALL has been attributed to an increased frequency of high-risk leukemia with greater resistance, poorer tolerance of and compliance with treatment, reluctance to accept toxic effects, and less effective treatment regimens as compared with childhood ALL. Currently, there are no fully-approved agents for adult Philadelphia chromosome negative ALL salvage, nor is there a consensus on the most appropriate regimen in the relapsed setting. Ongoing efforts are needed to investigate agents for this indication, as well as incorporate active agents, once identified, into front-line therapy.
About Hana Biosciences, Inc.
Hana Biosciences, Inc. (Nasdaq:HNAB) is a South San Francisco, CA-based biopharmaceutical company focused on acquiring, developing, and commercializing innovative products to strengthen the foundation of cancer care. The company is committed to creating value by building a best in-class team, accelerating the development of lead product candidates, expanding its pipeline by being the alliance partner of choice, and nurturing a unique company culture. Additional information can be found at: www.hanabiosciences.com.
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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding the timing, progress and anticipated results of the clinical development, regulatory processes, potential clinical trial initiations, potential IND and NDA filings and commercialization efforts of Hana's product candidates, including its Marqibo product candidate. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana's development efforts relating to its other product candidates will be successful, that Hana will be able to obtain regulatory approval of any of its product candidates, and that the results of clinical trials will support Hana's claims or beliefs concerning the effectiveness of its product candidates. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs to completion, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-Q for the quarter ended June 30, 2007 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.