Hana Reports Progress in Phase 2 Uveal Melanoma Trial
HANA BIOSCIENCES’ PHASE 2 CLINICAL TRIAL OF MARQIBO® FOR METASTATIC UVEAL MELANOMA MEETS CLINICAL RESPONSE CRITERIA TO ADVANCE TO FULL ENROLLMENT
SOUTH SAN FRANCISCO, CA (June 2, 2008) – Hana Biosciences (NASDAQ: HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the pre-specified efficacy criteria to proceed to full enrollment of 30 patients has been met in its Phase 2 clinical trial of Marqibo® (vincristine sulfate injection, OPTISOME™) for the treatment of metastatic malignant uveal melanoma.
In accordance with the Phase 2 trial protocol, a complete response (CR), a partial response (PR), or stable disease (SD) sustained for a minimum of twelve weeks by at least one patient among the first 15 treated with Marqibo was required for the trial to advance to the second stage. To date, although 15 patients have yet to be enrolled, more than one patient has achieved disease control. In addition, preliminary safety results show that Marqibo was well tolerated with no significant or unpredictable toxicities. The Phase 2 trial is currently being conducted at the University of Texas MD Anderson Cancer Center.
“We are very pleased to have met and surpassed the criteria for advancing this Phase 2 study to full enrollment,” said Anne E. Hagey, M.D., Vice President and Chief Medical Officer. “Marqibo has been well tolerated even in patients with abnormal liver function due to metastatic disease; and, while early, we are extremely encouraged by the outcomes of the patients in our trial. New clinical sites are coming on board as we look to expand the availability of Marqibo to patients with metastatic uveal melanoma where there are currently no approved treatment options.” “Because of the tremendous interest from the medical community for Marqibo, I am proud to say that we were able to beat our already aggressive timeline by six months,” stated Steven R.
Deitcher, M.D., President and CEO. “We have been able to transform a pilot trial into a formal Phase 2 study as a result of the activity we have seen, and the trial is progressing with a faster than anticipated pace of enrollment.” The primary objective of Hana’s Phase 2 study is to assess the efficacy of Marqibo as determined by Disease Control Rate (CR, PR, durable SD) in patients with metastatic malignant uveal melanoma. Secondary objectives are to assess the safety and antitumor activity of Marqibo as determined by response rate (CR, PR), progression-free survival, and overall survival. The patient population is defined as adults with uveal melanoma and confirmed metastatic disease that is untreated or that has progressed following one prior therapy.
_ Page 2 Two prior clinical trials of Marqibo in patients with metastatic melanoma demonstrated promising single-agent activity. In these studies of patients with histologically confirmed, surgically nonresectable metastatic cutaneous, mucosal, or uveal melanoma, 3 of 26 (12 percent) achieved an objective response (CR or PR) and 8 of 26 (31 percent) of patients achieved disease control (CR, PR, or SD). One of four subjects with metastatic uveal melanoma achieved a complete response.
About Uveal Melanoma Uveal melanoma is a relatively rare cancer of the colored part of the eye and the surrounding areas, called the uvea. Uveal melanoma is the most common primary intraocular malignant tumor in adults and represents five-to-six percent of all melanoma diagnoses. The incidence of uveal melanoma is reported to be approximately 2,500 patient cases per year. Metastasis occurs via vascular spread, and at least 40-50 percent of patients with primary uveal melanoma will ultimately develop metastases. Metastases of uveal melanoma have a different pattern of spread with nearly universal liver involvement. Metastatic uveal melanoma is considered unresponsive to systemic chemotherapy.
About Marqibo® (vincristine sulfate injection, OPTISOME™) Marqibo, a novel, targeted, Optisomal formulation of vincristine, has shown promising anti-cancer activity in patients with acute lymphoblastic leukemia (ALL), non-Hodgkin’s lymphoma, Hodkin’s disease, 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 extends the circulation time of vincristine in the bloodstream, increases targeting of the drug to malignant cells, and enhances 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 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 an alliance partner of choice, and nurturing a unique company culture. Further 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. 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, rates of patient enrollment and clinical trial site 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 _ Page 3 is no assurance that the current uveal melanoma trial will meet its study objectives or 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-K for the year ended December 31, 2007 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.
Investor & Media Contacts: Remy Bernarda Director, Investor
ph. (650) 228-2769 fax (650) 588-2787
Posted: June 2008