SOUTH SAN FRANCISCO, Calif., Nov. 20, 2007 (PRIME NEWSWIRE) -- Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced the dosing of the first two patients in a Phase 2 clinical trial of Marqibo(r) (vincristine sulfate injection, OPTISOME(tm)) for the treatment of metastatic malignant uveal melanoma.
The primary objective of Hana's Phase 2 study is to assess the efficacy of Marqibo as determined by response rates in patients with metastatic malignant uveal melanoma. Secondary objectives are to assess the safety and antitumor activity of Marqibo as determined by response duration, time to progression, 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. Hana expects to enroll up to 30 patients in this clinical trial, which is being conducted at the University of Texas MD Anderson Cancer Center.
The Phase 2 clinical trial is supported by data from a Phase 1 trial of Marqibo in patients with metastatic melanoma originating in the eye demonstrating promising single-agent activity. This data was reported earlier this year at the 43rd American Society of Clinical Oncology (ASCO) Annual Meeting by Dr. Patrick Hwu, Chair, Melanoma Medical Oncology at the University of Texas MD Anderson Cancer Center. In the Phase 1 study, an objective response rate (complete response plus partial response) of 13 percent and stable disease rate of 20 percent was achieved among 15 patients with histologically confirmed, surgically non-resectable metastatic cutaneous, mucosal, or uveal melanoma. One of four subjects with uveal melanoma metastatic to the lung achieved a complete response. Marqibo was generally well tolerated and showed promising single agent activity against metastatic melanoma.
"Patients with metastatic uveal melanoma generally do not respond to systemic chemotherapy and have limited treatment options. We are encouraged by the results we have seen to date with Marqibo and believe that it will benefit this patient population," said Agop Y. Bedikian, M.D., Professor in the Melanoma Medical Oncology Department at the University of Texas MD Anderson Cancer Center in Houston and the principal investigator for the trial.
"We are excited to initiate this Phase 2 trial based on clinical data that suggest that Marqibo has promising activity in melanoma, in addition to its potential in treating hematologic malignancies," stated Steven R. Deitcher, M.D., President and CEO of Hana Biosciences. "We are delighted to collaborate with world-renowned oncology experts like Dr. Bedikian and his team at MD Anderson Cancer Center to explore the potential of our novel therapeutics to improve treatment outcomes for patients with difficult-to-treat cancers."
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 3,500-4,000 per year. Metastasis is via vascular spread, and approximately 40-50 percent of patients with primary uveal melanoma will ultimately develop metastases. At the time of diagnosis, over 95 percent of patients have disease limited to the eye, but at least 30 percent of these patients will die of systemic metastases at five years and 45 percent at 15 years.(1) The liver is involved in up to 90 percent of individuals who develop metastatic disease.(2)(3) In general, metastatic uveal melanoma is unresponsive to systemic chemotherapy.
About Marqibo(r) (vincristine sulfate injection, OPTISOME(tm))
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, 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 neurotoxiciites.
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 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. Further information on Hana Biosciences 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.