Talon Therapeutics Announces Publication of the Marqibo(R) RALLY Study in the Journal of Clinical Oncology
Talon Therapeutics Announces Publication of the Marqibo(R) (vinCRIStine sulfate LIPOSOME injection) RALLY Study in the Journal of Clinical Oncology (JCO)
Data supported FDA accelerated approval of Marqibo (http://jco.ascopubs.org/)
Data published online ahead of print as a Rapid Communication
Data represents the per protocol, planned analysis based on established endpoints
SOUTH SAN FRANCISCO, Calif., Nov. 27, 2012 (GLOBE NEWSWIRE) -- Talon Therapeutics, Inc. (OTCBB:TLON), a biopharmaceutical company dedicated to developing leading oncology products, today announced the publication of the complete data from its Phase 2 RALLY Study of Marqibo in the Journal of Clinical Oncology, the official journal of the American Society of Clinical Oncology (ASCO). The study results were published as a rapid communication and online ahead of in print. Marqibo received FDA accelerated approval in August of this year for treatment of adult patients with Philadelphia chromosome negative (Ph-) ALL in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.
"This publication highlights the heavily pre-treated nature of this relapsed and refractory adult ALL population," said Steven R. Deitcher, MD, President and CEO of Talon. "The results of this study, in their totality, show that Marqibo facilitates vincristine dose-intensification and achievement of complete responses. Despite universal prior vincristine treatment and residual neurotoxicity in most patients, Marqibo's adverse event profile was comparable to that historically observed with non-liposomal vincristine."
The pivotal Phase 2 RALLY clinical trial enrolled a total of 65 evaluable patients at 22 sites in the U.S., Canada, Germany, and Israel. The primary objective of the RALLY clinical trial was to assess the efficacy of single-agent, once per week Marqibo 2.25 mg/m2 of actual patient body surface area as assessed by achievement of complete response (CR) or CR with incomplete blood count recovery (CRi). Secondary objectives included assessments of duration of CR/CRi, overall survival (OS), ability to undergo subsequent hematopoietic cell transplantation (HCT), safety, and pharmacokinetics. Marqibo was dosed weekly based on actual body surface area without any dose capping. The study population was defined as Philadelphia chromosome-negative adult patients in second or greater relapse, or those patients who relapsed following two lines of anti-leukemia chemotherapy, including those who have previously undergone HCT.
Marqibo is a novel, sphingomyelin/cholesterol liposome-encapsulated, formulation of vincristine sulfate. Vincristine, a microtubule inhibitor, is FDA-approved for ALL and Non-Hodgkin's Lymphoma (NHL) and is widely used in combination regimens for treatment for a variety of adult and pediatric hematologic and solid tumor malignancies. The OptisomeTM nanoparticle encapsulation technology, utilized by Talon, has been shown to provide prolonged circulation of vincristine in the blood.
Marqibo has received orphan drug designation for the treatment of ALL from the FDA and from the European Medicines Agency (EMA). Talon intends to submit a Marketing Authorization Application to the EMA in 2013.
Important safety information and full prescribing information for Marqibo can be found at www.marqibo.com.