- Conducted by the prestigious German High-Grade NHL Study Group
- R-CHMP-14 (M=Marqibo) versus R-CHOP-14 (O=standard vincristine)
- Powered to demonstrate superior progression-free survival of R-CHMP-14
SAN MATEO, Calif., Nov. 29, 2011 (GLOBE NEWSWIRE) -- Talon Therapeutics, Inc. (OTCBB:TLON) today announced the enrollment of the first patient in the Phase 3 Study of Marqibo® (vincristine sulfate liposomes injection) in adults over the age of 60 years with newly diagnosed aggressive Non-Hodgkin's Lymphoma. The study, called OPTIMAL>60, is being conducted by the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL).
"Enrolling the first patient in this Phase 3 study in adults with newly diagnosed aggressive NHL represents a significant milestone for Talon," stated Steven R. Deitcher M.D., President, Chief Executive Officer and Board Member of Talon Therapeutics. "In addition to the Phase 3 NHL study, the Company has also initiated a Phase 3 study in adults with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) which is expected to enroll the first patient early in 2012. We believe Marqibo has the potential to benefit patients with NHL and ALL by providing vincristine dose intensification while maintaining a predictable and manageable safety profile," Dr. Deitcher added.
This Phase 3, randomized NHL study builds upon the Phase 2 R-CHMP 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 OPTIMAL>60 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.
About Marqibo
Marqibo is a novel, targeted Optisome™ encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Talon has been developing Marqibo for the treatment of adult, Ph- ALL and adult aggressive NHL. 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's NDA seeking accelerated approval of Marqibo® (vincristine sulfate liposomes injection) has been accepted for filing by the FDA and is being reviewed by the FDA under Subpart H — Accelerated Approval of New Drugs for Serious or Life Threatening Illnesses, for 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 PDUFA date is May 13, 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, have the potential to improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity.
Additional information on Talon Therapeutics 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 Talon's ability to obtain accelerated approval of Marqibo for the treatment of adult Ph- ALL, the potential of Marqibo to be a safe and effective alternative for patients with NHL and ALL compared to existing therapies, the timing of initiating patient enrollment in Talon's Phase 3 clinical trial of Marqibo in adult 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 Talon will be able to secure the additional capital necessary to fund its product development programs, including Marqibo, to completion; 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; 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 and Quarterly Report on Form 10-Q for the period ending September 30, 2011. Talon assumes no obligation to update these statements, except as required by law.