Healthcare Industry News: Marqibo
News Release - December 20, 2006
Hana Biosciences Announces Filing of a Special Protocol Assessment (SPA) for Marqibo(R) (Vincristine Sulfate Liposomes Injection) in Relapsed Acute Lymphoblastic Leukemia
SOUTH SAN FRANCISCO, Calif.--(HSMN NewsFeed)--Hana Biosciences (Nasdaq:HNAB ), a biopharmaceutical company focused on advancing cancer care, today announced the filing of a request for a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for the design of a proposed registration trial for Marqibo® (vincristine sulfate liposomes injection) in adults with acute lymphoblastic leukemia (ALL) in second relapse and beyond."We are pleased to have the opportunity to obtain feedback and guidance from the FDA on our pivotal trial," stated Mark Ahn, PhD, President and Chief Executive Officer. "We believe this regulatory mechanism provides an important step forward in our clinical development for Marqibo."
The SPA process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of a new drug application. If the FDA determines that a submission is appropriate for an SPA, the SPA provides an agreement that the study design, including trial size, clinical endpoints and statistical package, is acceptable to the FDA. The proposed open-label Phase 2 pivotal trial will evaluate Marqibo in adult patients with ALL in second relapse and beyond.
About Marqibo® (vincristine sulfate liposomes injection)
Marqibo® utilizes vincristine encapsulated in a rigid, lipid bilayer of sphingomyelin. Vincristine, an FDA-approved, standard chemotherapeutic used in most lymphoma and ALL regimens, is a cell-cycle specific agent whose activity is dependent on the duration of drug exposure. The sphingosome encapsulated technology employed by Marqibo results in a more rigid liposome that is designed to allow the active vincristine to leak out of the liposome slowly, maintaining drug levels for prolonged periods of time. This improved pharmacokinetic profile of Marqibo, which mimics a continuous vincristine infusion, potentially results in greater activity in rapidly dividing cancers. The anticipated activity associated with vincristine has traditionally been limited by its short half-life, and its inability to be dose escalated beyond 2mg due to neurotoxicity. In Phase I and II clinical trials, Marqibo has shown to have a significantly longer half-life and patients have been able to tolerate doses which are approximately 100 percent greater than conventional vincristine. These trials provide the rationale for utilizing this technology in lymphoproliferative diseases, such as ALL, Hodgkin's and non-Hodgkin's lymphoma.
About Acute Lymphoblastic Leukemia (ALL)
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 approved agents for adult ALL salvage, nor is there a consensus on the most appropriate regimen in the relapse setting. Ongoing efforts are needed to investigate agents for this indication, as well as incorporate active agents, once identified, into frontline 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 advance cancer care. The company is committed to creating value by building a world-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 on Hana Biosciences can be found at www.hanabiosciences.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 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 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 Marqibo or its other product candidates will be successful. Other risks that may affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of Hana's product candidates, including Marqibo, the risk that the results of clinical trials may not support Hana's claims, 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2006 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.
Source: Hana Biosciences
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