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CytoDyn Files for Breakthrough Therapy Designation With the FDA for PRO 140 in HIV Therapy
GlobeNewswire•January 11, 2017
VANCOUVER, Washington, Jan. 11, 2017 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, today announced the Company filed a request for Breakthrough Therapy Designation with the FDA for PRO 140 as a treatment for HIV-1 infection in treatment-experienced patients with virologic failure.
While the standard of care for HIV infection has been a combination of medications from different antiretroviral classes that interfere with different steps of the HIV lifecycle, there is now a significant number of long-term survivors who are facing issues of drug resistance and need new treatment options. The Company believes this request for Breakthrough Therapy Designation addresses this unmet need for novel therapies for the growing number of heavily treatment-experienced HIV patients.
Based on results from four completed and ongoing clinical trials, the Company believes the PRO 140 treatment option addresses the unmet medical need for therapy options for HIV-1 infected patients with uncontrolled viral load, despite conventional Antiretroviral Therapy (ART).
Dr. Nader Pourhassan, CytoDyn’s President and CEO, commented: “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. We believe PRO 140 has demonstrated its value as a combination therapy and as a single agent in patients with the R5 strain of HIV and are hopeful that receiving Breakthrough Therapy Designation will speed our BLA process to get this product to the market.”