Progenics’ HIV Drug Put on Fast Track

Progenics said Wednesday its HIV treatment PRO 140 has been given fast-track status by the Food and Drug Administration.

PRO 140 is in a new class of HIV drugs called viral-entry inhibitors, which are intended to protect healthy cells from infection by the HIV virus, the company said.

The treatment is a humanized monoclonal antibody that specifically targets CCR5, a molecular portal that HIV uses to enter cells.

Progenics is currently testing the drug in phase 1b clinical trials.

The FDA grants fast-track status to drugs that treat serious diseases and would fulfill an unmet medical need.

The designation means the therapy will likely be reviewed within six months and also allows the company to use surrogate endpoints — or data gleaned at an earlier point in the study — to demonstrate safety and effectiveness.

Although great strides have been made in HIV treatment, there is an urgent need for the development of new therapies such as PRO 140 to address the limitations of currently available HIV drugs, said Paul Maddon, Progenics’ founder, chief executive officer and chief science officer.