In just a couple of days, Talon Therapeutics Inc. (TLON.OB) will know the FDA's final decision on Marqibo, its investigational drug for the proposed treatment of adult Philadelphia chromosome-negative acute lymphoblastic leukemia.
Marqibo consists of vincristine sulfate encapsulated in the aqueous core of proprietary, sphingomyelin-based liposome called Optisomes. Vincristine is FDA-approved under the name Oncovin and marketed by Eli Lilly & Co. (LLY: Quote) for acute lymphoblastic leukemia, or ALL, and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies such as lymphoma and leukemia. Marqibo - the encapsulation formulation of Vincristine is designed to enhance efficacy with the potential for reduced toxicity.
Marqibo cleared the penultimate regulatory hurdle on March 21, 2012, with the Oncologic Drugs Advisory Committee voting 7-4, recommending approval of the drug for the proposed indication, with 2 abstentions.
The FDA was supposed to have announced its final decision on May 13th itself. But with the regulatory agency seeking additional information unrelated to clinical trials regarding Marqibo on May 7, the decision date got deferred by 3 months to August 12. The FDA isn't required to follow the advice of its panels but usually does.
Given the fact that there are 2,600 new cases of refractory or relapsed Philadelphia chromosome negative acute lymphoblastic leukemia per year, the relapsed adult ALL market is estimated to be more than $100 million annually.
Meanwhile, as recently as June 1, 2012, Talon initiated a phase III confirmatory study of Marqibo in adults (60 years of age and older) with newly diagnosed Philadelphia chromosome negative acute lymphoblastic leukemia.
Marqibo is also being evaluated in an on-going phase III trial in front-line adult elderly aggressive non-Hodgkin's lymphoma conducted by the German High Grade Non-Hodgkin's Lymphoma Study group, and in a phase I trial in pediatric cancers, including ALL, being conducted by the National Cancer Institute. A phase II trial of Marqibo in front-line adult ALL to be conducted by the M.D. Anderson Cancer Center is expected to begin enrolling this quarter. (3Q, 2012).
The FDA has conferred orphan drug and fast track designations for Marqibo for the treatment of adult ALL. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency.
Another compound of importance in Talon's pipeline is Menadione Topical Lotion for the prevention and treatment of skin toxicity associated with Epidermal Growth Factor Inhibitor cancer treatments, which is under phase II study. The study, sponsored by Mayo Clinic, was initiated in January of this year. The company plans to seek partnerships for phase III study of Menadione, which is expected to be initiated next year.
Talon's stock, which is quoted on the OTC Bulletin Board, has thus far hit a low of $0.40 and a high of $1.83. The stock was featured on our site last August when it was trading around $0.93.
Will Marqibo pass muster with the FDA? It will be interesting to watch how the stock price plays out before and after the big day. Stay tuned...
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by RTT Staff Writer
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