Talon Therapeutics, Inc., announced the company has reached agreement with the US Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for its planned phase III study of Marqibo (vincristine sulfate liposomes injection) in adults with newly diagnosed Philadelphia chromosome negative (Ph-) Acute Lymphoblastic Leukaemia (ALL).

Talon submitted a new drug application (NDA) to the FDA in July 2011 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-leukaemia therapy. The phase III study now under SPA, named HALLMARQ (Halting newly diagnosed Adult acute Lymphoblastic Leukemia with Marqibo containing chemotherapy), is intended to be a confirmatory study to be completed following the accelerated approval of Marqibo. Talon expects to know if the NDA has been accepted for filing by the FDA in mid-September 2011.

“Receiving an SPA from the FDA is a major accomplishment for Talon. The SPA represents a written agreement between Talon and the FDA regarding the planned design, conduct, and analysis of our phase III ALL trial called HALLMARQ,” stated Steven R Deitcher, president, CEO and Board Member of Talon Therapeutics. “HALLMARQ will be a global trial with initial clinical site openings expected in the US prior to the end of 2011.”

“A phase III, Multicentre, Randomized Study to Evaluate the Substitution of Marqibo (Vincrisitne Sulfate Liposomes Injection, VSLI) for Standard Vincristine Sulfate Injection (VSI) in the Induction, Intensification, and Maintenance Phases of Combination Chemotherapy in the Treatment of Subjects = 60 Years Old with Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL).”

Its primary objective is to compare overall survival (OS) among subjects 60 years of age and older with newly diagnosed ALL who receive Marqibo versus standard vincristine as a component of multi-agent induction, intensification, and maintenance chemotherapy. The study is powered for superiority.

Eligible subjects will be randomized to a standardized and widely accepted combination chemotherapy regimen containing either VSI or Marqibo. Treatment will be divided into induction, intensification, and maintenance phases of therapy. The sample size is event driven with a projected total enrollment of 350 to 400 patients.

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, 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 haematologic malignancies such as lymphomas and leukaemias. Talon's encapsulation formulation is designed to provide prolonged circulation of the drug in the blood and accumulation at the tumour site. These characteristics are intended to increase the dose of vincristine delivered in a safe and effective manner.

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.