SOUTH SAN FRANCISCO, Calif., March 10, 2011 (GLOBE NEWSWIRE) -- Talon Therapeutics, Inc. (OTCBB:TLON), today announced the issuance of U.S. patent 7,887,836 B2, which covers compositions and methods for treating lymphoma, leukemia and myeloma for Marqibo (vincristine sulfate liposome injection). The patent expires in March 2020. A previously issued patent covers Marqibo's use for treating relapsed acute lymphoblastic leukemia (ALL).
"We believe Marqibo has the potential to be an effective treatment beyond our initial sought indication of adult Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy," stated Steven R. Deitcher, M.D., President and Chief Executive Officer of Talon Therapeutics. "We are pleased the newly issued patent broadens our potential disease coverage to include lymphoma, leukemia and myeloma for front line and relapsed treatment."
Pursuant to its license agreement with Tekmira and related sublicense with the University of British Columbia, Talon has exclusive rights to 14 issued U.S. patents (including the newly-issued patent), 78 issued foreign patents, 4 pending U.S. patent applications and 19 pending foreign applications, covering composition of matter, method of use and treatment, formulation and process. These patents and patent applications cover sphingomyelin and cholesterol liposome-based pharmaceutical compositions including Marqibo and two other compounds, formulation, dosage, process of making the liposome compositions, and methods of use of the compositions in the treatment cancer, relapsed cancer, and solid tumors.
About Marqibo(R) (vincristine sulfate liposome injection)
Marqibo is a novel, targeted Optisome™ encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Talon is primarily developing Marqibo for the treatment of adult Ph- ALL. Vincristine, a microtubule inhibitor, is FDA-approved for ALL and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies such as lymphomas and leukemias. Talon's encapsulation formulation is designed to provide prolonged circulation of the drug in the blood and accumulation at the tumor site. These characteristics are intended to increase the dose of vincristine delivered in a safe and effective manner.
Based on the data from the Phase 2 pivotal RALLY study, in the first half of 2011 Talon plans to submit to the FDA a New Drug Application, or NDA, seeking accelerated approval of Marqibo in Ph- adult ALL, in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy.
Talon has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation in adult leukemia from the European Medicines Evaluation Agency.
About Talon Therapeutics
Talon Therapeutics, Inc. is a biopharmaceutical company dedicated to seizing upon medical opportunities, efficiently and expertly leading product candidates through clinical development, and transferring value to patients, patient care providers, shareholders, corporate partners, and employees.
In addition to Marqibo, the Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity.
Additional information on Talon Therapeutics can be found at .
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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 of planned regulatory filings relating to Marqibo, Talon's ability to obtain accelerated approval of Marqibo for the treatment of adult Ph- ALL, and the potential of Marqibo to replace existing therapies. Such statements involve risks and uncertainties that could cause Talon'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 Talon's clinical and regulatory development efforts relating to Marqibo will be successful; that even if an NDA for Marqibo is accepted by the FDA, that it will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of an NDA for Marqibo; that the results of the clinical trials of Marqibo will support Talon's claims or beliefs concerning Marqibo's safety and effectiveness; and that Talon will be able to secure the additional capital necessary to fund its product development programs, including Marqibo, to completion, Talon'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, 2009 and in the Company's Form 10-Q for the three month period ended March 31, 2010. Talon assumes no obligation to update these statements, except as required by law.
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