HANA BIOSCIENCES GETS U.S.ORPHAN DRUG DESIGNATION FOR MARQIBO.
"We are pleased to have received orphan designation from the FDA for Marqibo in metastatic uveal melanoma, a cancer with a clear unmet medical need. We believe this recognizes the need to pursue these difficult disease indications," said Anne E. Hagey, M.D., vice president and chief medical officer. "We look forward to working with the Agency on our ongoing program in uveal melanoma to find a safe and efficacious therapy that can help these patients."
Hana is currently conducting a Phase 2 clinical trial to assess the efficacy of Marqibo as determined by Disease Control Rate (complete response (CR), partial response (PR), durable stable disease) in patients with metastatic malignant uveal melanoma. Secondary objectives are to assess the safety and anti-tumor 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. The Phase 2 trial is currently being conducted at the University of Texas MD Anderson Cancer Center.
About Orphan Drug Designation
The Orphan Drug Act provides for incentives to encourage the development of drugs for rare disease conditions affecting fewer than 200,000 people in the United States. Upon FDA approval, orphan drug designation entitles Hana Biosciences to seven years of market exclusivity for Marqibo(r) (vincristine sulfate injection, OPTISOME(tm)) in the treatment of adult patients with metastatic uveal melanoma. Additional incentives include tax credits related to clinical trial expenses, a possible exemption from the FDA-user fee, and assistance in clinical trial protocol design.
About Uveal Melanoma
Uveal melanoma is a relatively rare cancer which includes the pigmented 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-twelve percent of all melanoma diagnoses. The incidence of uveal melanoma is reported to be up to 5,000 patient cases per year. Metastasis occurs via vascular spread, and at least 40-70 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 and immunotherapy.
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, Hodgkin'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.
For more information, visit http://www.hanabiosciences.com or call 650/228-2769.
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|Date:||Aug 1, 2008|
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