CytoDyn Inc, a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, has announced that its ongoing extension study of PRO 140 mono-therapy in a cohort of HIV-infected patients has shown complete viral-load suppression for well over a year with some patients approaching 17 months.
The company believes that complete virologic suppression through treatment with a single agent, PRO 140, a safe and efficacious antibody, rather than through the widely used HAART combination therapy, could present a significant opportunity to treat HIV patients.
Based on these mono-therapy results, the company plans to file a second Phase 3 protocol for PRO 140 mono-therapy with the US Food and Drug Administration. CytoDyn is currently conducting a pivotal Phase 3 trial for PRO 140 as an adjunct therapy with expected commercialisation in 2017.
Dr Nader Pourhassan, CytoDyn’s president and CEO commented that: “We believe PRO 140 can effectively address adherence to a complex therapeutic regimen, which is a major challenge in today’s HIV world. Only about 25% of HIV patients in the US have a completely suppressed viral load. A large contributor to this problem is due to patients’ inability to adhere to a highly structured schedule to take their medications on a specific timetable every day of their lives (Anti-Retroviral Therapy or ART). PRO 140 is administered as a simple, weekly subcutaneous injection and could be the solution to this very serious adherence problem. Moreover, our clinical trials to date have clearly indicated that PRO 140 is safe and efficacious without the side effects and toxicities experienced in the current ART therapeutic regimen. We are optimistic about our current and upcoming trials of PRO 140 and believe our antibody presents a compelling alternative or adjunct therapy to ART for HIV patients.”Global Newswire material