Source: Cardiology  |  Posted 5 years ago

WESTMINSTER, CO -- October 3, 2006 -- Allos Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation to the Company's unique next-generation antifolate PDX (pralatrexate) for the treatment of patients with T-cell lymphoma.

The fast track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track designation allows a company to submit portions of a new drug application (NDA) on a rolling basis, allowing the FDA to review sections of the NDA prior to receiving the complete application. In addition, a NDA for a fast track product ordinarily qualifies for priority review, thereby further expediting the FDA review process.

"We are extremely pleased that the FDA has recognized the urgent and unmet medical need for effective new therapies for the treatment of patients with T- cell lymphoma," said Paul L. Berns, President and Chief Executive Officer. "Fast track designation represents a significant regulatory milestone in the development of PDX, and further validates the potential of PDX in this patient population."

PDX is currently the subject of a pivotal Phase 2, international, multi-center, open-label, single-arm study that will seek to enroll 100 evaluable patients with relapsed or refractory PTCL who have progressed after at least one prior treatment. The primary endpoint of the study is objective response rate (complete and partial response). Secondary endpoints include duration of response, progression-free survival and overall survival.

In August 2006, the Company announced that it reached agreement with the FDA under the Special Protocol Assessment process on the design of this pivotal Phase 2 trial. The Company currently anticipates that patient enrollment at approximately 35 centers in the U.S., Canada and Europe will be completed by the third quarter of 2008. In July 2006, the FDA awarded orphan drug designation to PDX for the treatment of patients with T-cell lymphoma.

About PDX (pralatrexate)
PDX is a novel, small molecule chemotherapeutic agent that inhibits dihydrofolate reductase (DHFR), a folic acid (folate) dependent enzyme involved in the building of DNA and other processes. PDX was rationally designed for improved transport into tumor cells via the reduced folate carrier (RFC-1), and greater intracellular drug retention. These biochemical features, together with preclinical data in a variety of tumors, suggest that PDX has an enhanced potency and improved toxicity profile relative to methotrexate and other related DHFR inhibitors.

About Peripheral T-cell Lymphoma
Peripheral T-cell lymphomas, or PTCLs, are a biologically diverse and uncommon group of blood cancers that account for approximately 10% to 15% of all cases of non-Hodgkin's lymphoma, or about 6,700 patients annually. The average five year survival rate for PTCL patients is approximately 25%. There are currently no pharmaceutical agents approved for use in the treatment of relapsed or refractory PTCL.

SOURCE: Allos Therapeutics, Inc.