SAN MATEO, Calif., May 7, 2012 (GLOBE NEWSWIRE) -- Talon Therapeutics Inc., (OTCBB:TLON), today announced that it has been informed by the U.S. Food and Drug Administration (FDA) that its New Drug Application (NDA) seeking accelerated approval of Marqibo® has been given a three-month Prescription Drug User Fee Act (PDUFA) date extension to August 12, 2012.
On March 21, 2012, the Oncologic Drugs Advisory Committee (ODAC) voted 7 to 4, with 2 abstentions, that evidence from clinical studies supports a favorable benefit/risk assessment for use of Marqibo(R) in the treatment of adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or that has progressed following two or more lines of anti-leukemia therapy. The FDA has requested additional information unrelated to clinical trials regarding Marqibo. Talon has submitted responses to all outstanding requests. The FDA has informed Talon that in order to complete its review of the submitted information, the FDA has extended the Marqibo PDUFA date for 3 months.
"We will continue to work collaboratively with the FDA during this review process and will continue on-going label negotiations," stated Steven R. Deitcher MD, President, Chief Executive Officer and Board Member of Talon Therapeutics. "In addition, we will continue to conduct our Phase 3 confirmatory trial, which received Special Protocol Assessment agreement from the FDA, in front-line adult elderly ALL," Dr. Deitcher added.
About Marqibo(R) (vincristine sulfate liposome injection)
Marqibo is a novel, targeted Optisome(TM) encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Talon is primarily developing Marqibo for the treatment of Ph- adult 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.
Talon has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the FDA. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency.
In addition to the Phase 3 confirmatory study of Marqibo in front-line adult elderly ALL, Marqibo is being evaluated in an on-going Phase 3 trial in front-line adult elderly aggressive non-Hodgkin's lymphoma conducted by the German High Grade Non-Hodgkin's Lymphoma Study group, and in a Phase 1 trial in pediatric cancers, including ALL, being conducted by the National Cancer Institute. A phase 2 trial of Marqibo in front-line adult ALL to be conducted by the M.D. Anderson Cancer Center is expected to begin enrolling in the third quarter of 2012.
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.
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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 potential of Marqibo to replace existing therapies, the timing of Talon's ongoing and planned clinical trials, and Talon's ability to obtain approval of its Marqibo NDA. 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. Such risks and uncertainties include: that there can be no assurances that any of Talon's clinical and regulatory development efforts relating to Marqibo will be successful; that Talon's NDA for Marqibo will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of the 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; 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, 2011. Talon assumes no obligation to update these statements, except as required by law.
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SOURCE: Talon Therapeutics, Inc.