VANCOUVER, Wash.—CytoDyn Inc. has filed a request with the FDA for Breakthrough Therapy Designation for PRO 140 for HIV-1 infection in treatment-experienced patients with virologic failure. Results from four completed and ongoing clinical trials suggest PRO 140 can address unmet medical needs for HIV-1 patients with uncontrolled viral load despite conventional antiretroviral therapy.

 

Dr. Nader Pourhassan, CytoDyn’s president and CEO, said: “Investigators from several sites have requested continued access to PRO 140 to allow patients to continue deriving clinical benefit and maintain HIV-1 viral suppression after the end of treatment in the CD02 Phase 3 combination therapy study. Seven patients have entered the rollover study to receive continued access to PRO 140 after the completion of the 25-week treatment period in this study. Additionally, 10 patients in the ongoing Phase 2b extension arm of Monotherapy trial have shown suppressed viral load for two years.”