Progenics Pharmaceuticals' PRO 140 has been designated a fast track product by the US Food and Drug Administration (FDA) for the treatment of human immunodeficiency virus (HIV) infection.
PRO 140 belongs to a new class of HIV/AIDS therapeutics, viral-entry inhibitors, that are intended to protect healthy cells from viral infection. PRO 140, currently in phase 1b clinical trials in HIV-infected individuals, is a humanised monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter cells, states the company release.
"Fast-track status has the potential to accelerate the development of PRO 140. 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 J. Maddon, Progenics' founder, chief executive officer and chief science officer.
PRO 140 may be considered for priority review (six-month versus standard ten-month review) as well as accelerated approval.
Progenics Pharmaceuticals Inc. is a biopharmaceutical company focusing on the development and commercialisation of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases.