Progenics' HIV drug PR104 fast tracked by US FDA

The USA's Progenics Pharmaceuticals says that its drug candidate PRO 140 has been designated a fast track product by the Food and Drug Administration for the treatment of human immunodeficiency virus infection. The agent, which belongs to a new class of therapeutics intended to protect healthy cells from infection, is a humanized monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter cells. The agent is currently in Phase Ib clinical trials in HIV-infected individuals and its designation entitles it to a priority six-month versus standard 10-month review, as well as accelerated approval. Progenics may also submit its New Drug Application on a rolling basis, enabling the FDA to commence review of sections of the application before it is fully completed.