SOUTH SAN FRANCISCO, Calif., Oct. 31, 2006 (PRIMEZONE) -- Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on advancing cancer care, today announced the initiation of a multicenter Phase II clinical trial with Talvesta(tm) (talotrexin) for Injection in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
The primary objective of this Phase II portion of an ongoing Phase I/II open-label study is to evaluate the complete remission rate (CR/CRp) of Talvesta in relapsed or refractory ALL patients. Secondary objectives are to evaluate the safety and tolerability of Talvesta in this setting as well as duration of complete remission and overall survival. Data from the Phase I portion of this clinical trial will be presented during the 48th Annual American Society of Hematology (ASH) Meeting in December in Orlando, Florida, on Sunday, December 10th.
"We are pleased to advance Talvesta into a Phase II trial in adults with relapsed ALL, a disease with few effective therapeutic options," commented Greg Berk, MD, Senior Vice President and Chief Medical Officer of Hana Biosciences. "We look forward to presenting the Phase I data at ASH in December, and are excited to have recruited several major leukemia referral centers into this important trial."
About Talvesta(tm) (talotrexin) for Injection
Talvesta is a novel, nonpolyglutamable antifolate drug which targets DHFR under development for the treatment of various types of cancers. Talvesta has demonstrated enhanced antitumor activity in a broad spectrum of preclinical studies by targeting the enzyme DHFR to prevent DNA synthesis in tumor cells and inhibit tumor growth. These studies suggest that Talvesta, as compared to other antifolates, enters into cells up to ten times more efficiently and demonstrates 10- to 100-fold more potency in overcoming polyglutamation, a well-established mechanism of antifolate resistance. Talvesta also binds more tightly to its anti-tumor target DHFR, which Hana believes may further inhibit tumor growth. In May 2006, the U.S. Food and Drug Administration granted orphan drug designation for Talvesta in patients with ALL. In addition, Talvesta is also being studied in a Phase I in solid tumors and a Phase I/II in non-small cell lung cancer (NSCLC).
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 Talvesta and 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 Talvesta, 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.