HBX Hana Biosciences

Hana Biosciences (AMEX:HBX), a biopharmaceutical company focused on advancing cancer care, today reviewed 2005 progress and announced its corporate objectives for 2006. Key 2005 achievements for Hana include: -- Q1 05: Zensana(TM) pilot pharmacokinetic study demonstrated pharmacokinetic profile comparable to oral Zofran(R), with multidose convenience and faster drug delivery. -- Q1 05: Initiated Talotrexin Phase I/II trial in non-small cell lung cancer (NSCLC) -- Q1 05: IPdR abstract/poster at the American Association for Cancer Research (AACR) meeting demonstrated IPdR effective in glioblastoma xenografts. -- Q2 05: Began Talotrexin Phase I/II trial in adult relapsed/refractory ALL (acute lymphocytic leukemia) -- Q3 05: Began IPdR Phase I trial in colorectal, gastric, liver, and pancreatic cancers -- 2H 05: Commenced Zensana(TM) pivotal studies under 505(b)(2) registration -- 2H 05: Reported interim Talotrexin Phase I/II trial results in NSCLC at AACR-EROTC Key 2006 objectives for Hana include: -- 1H 06: Announce results of Zensana(TM) pivotal studies -- 1H 06: Announce results from Phase I clinical trials in NSCLC, ALL, and solid tumors -- 1H 06: Initiate Talotrexin Phase II trial in NSCLC, with potential interim results in Q4 06 -- 1H 06: Initiate Talotrexin Phase II trial in other tumor type -- 1H 06: Submit Zensana(TM) NDA under 505(b)(2) registration, with potential US '07 market launch -- 2H 06: Initiate additional Zensana(TM) clinical trials in chemotherapy-induced nausea and vomiting (CINV) -- 2H 06: Initiate additional IPdR Phase I/II trial in glioblastoma multiforme (GBM) and/or neoadjuvant rectal cancer -- 2H 06: Complete IPdR Phase I trial in gastric, colorectal, pancreatic and liver cancers "The Hana team made significant progress against the company's 2005 goals for all three clinical stage products. We are confident that we will meet and exceed Hana's 2006 goals, including successfully passing the milestones that will help us launch Zensana(TM) commercially in 2007," said Mark Ahn, PhD, President and CEO. Hana also announced that it intends to hold an annual shareholder meeting and an analyst pipeline update teleconference on May 9, 2006, during which the company intends to provide a review of all clinical programs. Product Pipeline Summary Talotrexin (PT-523) is a novel nonpolyglutamatable antifolate drug which has demonstrated enhanced antitumor activity in a broad spectrum of cancers by targeting DHFR to prevent DNA synthesis and inhibit tumor growth. Compared to currently available antifolates such as methotrexate or pemetrexed (Alimta(R); Eli Lilly) in preclinical studies, Talotrexin enters into cells up to 10-times more efficiently, demonstrated 10 to 100 fold more potency by overcoming resistance by remaining active in tumors by not requiring polyglutamation, and binds more tightly to its anti-tumor target DHFR which enhances efficacy. Thus, Phase I trial in solid tumors, Phase I/II trial in NSCLC (non-small cell lung cancer), and Phase I/II trial in ALL (acute lymphocytic leukemia) are ongoing. Phase II trials in cervical, endometrial, and ovarian cancers are forthcoming. Zensana(TM) (ondansetron oral spray) is a novel oral spray formulation of ondansetron (Zofran(R);GlaxoSmithkline) that uses the vast and highly-absorptive surfaces of the oral mucosa to deliver drug directly into the blood stream to prevent chemotherapy, radiation and post-operative induced nausea and vomiting. Taking pills for patients experiencing nausea and vomiting can be problematic. Drug delivery via the oral mucosa avoids degradation in the gastrointestinal tract and metabolism by liver enzymes -- the so-called first-pass effect. Zensana(TM) is being developed as a 505(b)(2) registration and targets a 2007 launch in the US. IPdR is a novel, orally available, thymidine analogue and prodrug for IUdR, which demonstrated survival advantage in Phase II studies in anaplastic astrocytoma, a type of brain tumor. Preclinical studies have also demonstrated that IPdR has a dose responsive and synergistic effect when combined with radiation in human glioblastoma models. IPdR also showed superior safety and efficacy in comparison to IUdR, with a significantly lower toxicity profile (lower gastrointestinal and hematological side effects). IPdR is initially being developed in a Phase I clinical trials for the treatment of colorectal, gastric, liver, and pancreatic cancers. In addition, a Phase I/II clinical trial in glioblastoma multiforme, a type of brain cancer, is planned. About Hana Biosciences, Inc. Hana Biosciences, Inc. (AMEX:HBX) is a South San Francisco, CA-based biopharmaceutical company that acquires, develops, and commercializes 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, including the statements in this press release concerning Hana's 2006 corporate goals and objectives, 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 Hana will achieve the goals and objectives outlined in this press release or that any of Hana's development efforts relating to its 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, 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 pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-KSB for the year ended Dec. 31, 2004. Hana assumes no obligation to update these statements, except as required by law.