Progenics gets FDA fast track designation for PRO 140 HIV/AIDS drug

By Ted A. Knutson

Washington, Feb. 22 - Progenics Pharmaceuticals, Inc. announced that PRO 140 has been designated a fast track product by the Food and Drug Administration for the treatment of human immunodeficiency virus (HIV) infection.

The FDA fast track development program facilitates development and expedites regulatory review of drugs intended to address an unmet medical need for serious or life-threatening conditions.

PRO 140 belongs to a new class of HIV/AIDS therapeutics - viral-entry inhibitors - that are intended to protect healthy cells from viral infection. The experimental drug, currently in phase 1b clinical trials in HIV-infected individuals, is a humanized monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter cells.

With fast track designation for PRO 140, Progenics said it can take advantage of several programs at the FDA to streamline the regulatory review process and to work more closely with the agency on product development plans. In addition, PRO 140 may be considered for priority review - six-month versus standard 10-month review - as well as accelerated approval.

Sponsors of fast track products are also eligible to submit a New Drug Application on a rolling basis, enabling the FDA to begin the review of sections of the application before receiving a complete application. FDA may also approve a fast track product if it has an effect on a surrogate endpoint that is likely to predict its clinical benefit.

The company added PRO 140 may represent a new treatment paradigm for HIV patients, because it has the potential to address the limitations of currently available therapies, including the emergence of multi-drug-resistant viruses, significant side effects, drug-drug or drug-food interactions, and often-complex daily treatment regimens.

Progenics is a Tarrytown, N.Y.-based biotechnology company.

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