Progenics selects new HIV antibody therapy for further development

The decision follows positive results from a recently completed Phase II clinical trial as well as feedback from key opinion leaders, treatment advocates and people living with HIV. In this Phase II clinical trial, the subcutaneous dosage form of PRO 140 demonstrated potent and highly significant antiviral effects compared to placebo at all doses of active drug examined and was generally well tolerated.

The data presented also indicate that PRO 140 has the potential to be administered weekly, which may facilitate its use in conjunction with other antiretroviral therapies, the company said.

PRO 140 is a humanized monoclonal antibody that blocks viral infection of healthy cells by binding to CCR5, a co-receptor that is the principal molecular portal used by HIV to enter and infect immune system cells.

Paul Maddon, founder, CEO and chief science officer of Progenics, said: We plan to meet with the FDA to discuss registrational studies for subcutaneous PRO 140. Similar to intravenous PRO 140, the subcutaneous form has demonstrated significant antiviral activity and favorable tolerability in clinical trials to date, with the additional potential benefit of convenient self-administration by patients.

Given that all currently available HIV drugs are given between one and three times daily, a weekly therapy could have many advantages related to adherence.