Talon Therapeutics to Commence Phase III Study of Marqibo

Talon Therapeutics, Inc. recently announced the initiation of a Phase III study of Marqibo (vincristine sulfate liposomes injection) in elderly patients with newly diagnosed aggressive Non-Hodgkin’s Lymphoma to be conducted by the German High-Grade Non-Hodgkin’s Lymphoma Study Group (DSHNHL).

“The German High-Grade Non-Hodgkin’s Lymphoma Study Group is one of the most well-regarded hematologic malignancy-focused cooperative groups in the world, and we are very pleased to be supporting them in this important study,” said Steven R. Deitcher, MD, President, Chief Executive Officer, and Director of Talon Therapeutics. “We agree with DSHNHL that Marqibo facilitated vincristine dose intensification while maintaining a predictable and manageable safety profile in NHL has the potential to benefit patients.”

This Phase III, randomized study, expected to begin patient treatment in the third quarter of 2011, builds upon Phase II data from a study of Marqibo in NHL that is currently under review at a major oncology journal. The title of the DSHNHL study is Improvement of Outcome and Reduction in Toxicity in Elderly Patients With CD20+ Aggressive B-cell Lymphoma by an Optimized Schedule of the Monoclonal Antibody Rituximab, Substitution of Conventional by Liposomal Vincristine and FDG-PET Based Reduction of Therapy.

The study will enroll approximately 1,000 patients (61-80 years of age) with aggressive CD20+ B-cell NHL. The primary objectives are to test the effects of substituting conventional vincristine with Marqibo in the R-CHOP regimen and to test the effects of an optimized application of rituximab. The Principal Investigator for this study is the internationally recognized Professor Dr. Michael Pfreundschuh.

Talon and DSHNHL completed protocol development and an investigator meeting, and anticipate first-patient-in during the third quarter of 2011. Talon will fund a portion of this Phase III study in NHL as part of its Marqibo development program.

Marqibo is a novel, targeted Optisome-encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Until now, 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.

Talon plans to submit to the FDA an NDA 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, by the end of June 2011. Talon has received orphan drug and fast-track designations for Marqibo for the treatment of adult ALL from the US FDA. Marqibo has also received orphan drug designation in adult leukemia from the European Medicines Evaluation Agency.

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, have the potential to improve delivery and enhance the therapeutic benefits of well-characterized, proven chemotherapies and enable high-potency dosing without increased toxicity.