SAN MATEO, Calif., July 20, 2011 (GLOBE NEWSWIRE) -- Talon Therapeutics, Inc. (OTCBB:TLON) today announced the enrollment of the first patient in a Phase 1 trial to evaluate the safety, activity and pharmacokinetics of Marqibo® (vincristine sulfate liposomes injection) in children and adolescents with relapsed or refractory cancer being conducted by the Pediatric Branch of the National Cancer Institute (NCI). http://clinicaltrials.gov/ct2/show/NCT01222780
"Marqibo has the potential to improve the prognosis for children and adolescents with solid tumors and hematologic malignancies. Like adults with relapsed leukemias and lymphomas, there is a need for new and improved treatments for children and adolescents with relapsed and refractory cancers. We look forward to working with Alan S. Wayne, M.D., Clinical Director of the Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, the principal investigator for this study," stated Steven R. Deitcher, President, Chief Executive Officer and Board member Talon Therapeutics.
The objectives of the trial are to (1) define the maximum tolerated dose, toxicity profile, dose-limiting toxicities, and pharmacokinetics in children and adolescents with solid tumors or hematologic malignancies and (2) to define the tolerability and potential activity of Marqibo in children and adolescents with relapsed or refractory acute lymphoblastic leukemia (ALL) at the pediatric maximum tolerated dose.
About Marqibo
Marqibo is a novel, targeted Optisome™ encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Talon has been primarily developing Marqibo for the treatment of adult, Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (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.
In July 2011, Talon submitted a New Drug Application seeking accelerated approval of Marqibo in adult Ph- 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 FDA. Marqibo has also received orphan drug designation in adult leukemia from the European Medicines Evaluation Agency. Marqibo is also being studied in a Phase 3 clinical trial to treat Non-Hodgkin's Lymphoma conducted by the German High Grade Non-Hodgkin's Lymphoma Study Group.
About Talon Therapeutics, Inc.
Talon Therapeutics, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. Talon is developing its lead product candidate, Marqibo, primarily for the treatment of acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities some of which, like Marqibo, are designed to improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at www.talontx.com.
The Talon Therapeutics, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290
Forward-Looking Statement
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 ability of Marqibo to replace existing therapies and improve the prognosis for cancer patients, Talon's ability to obtain accelerated approval of Marqibo for the treatment of adult Ph- ALL, and the timing, progress and anticipated results of the clinical development of Marqibo and Talon's other product candidates. 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 accepted for filing by the FDA and, even if the NDA 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 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, 2010. Talon assumes no obligation to update these statements, except as required by law.