Talon Therapeutics Receives Special Protocol Assessment Agreement from the Food and Drug Administration for Its Phase 3 Confirmatory Study of Marqibo(R) in Newly Diagnosed Acute Lymphoblastic Leukemia
SAN MATEO, Calif., Aug. 29, 2011 (GLOBE NEWSWIRE) -- Talon Therapeutics, Inc., (OTCBB:TLON), announced today the company has reached agreement with the U. S. Food and Drug Administration (FDA) regarding a special protocol assessment (SPA) for its planned Phase 3 study of Marqibo® (vincristine sulfate liposomes injection) in adults with newly diagnosed Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (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-leukemia therapy. The Phase 3 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 3 ALL trial called HALLMARQ," stated Steven R. Deitcher, President, Chief Executive Officer 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."
About the HALLMARQ Study
Title: "A Phase 3, Multicenter, 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 Leukemia (ALL)."
Primary Objective: 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.
Study Design and Methodology: 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 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.
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
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 existing therapies, the timing of initiating Talon's proposed Phase 3 clinical trial of Marqibo, 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.
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Source: Talon Therapeutics, Inc.
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