CytoDyn (CYDY) Seeks Breakthrough Therapy Designation for Innovative HIV Therapy PRO 140

A growing number of human immunodeficiency virus (HIV) patients are in need of new treatment as they start facing issues of drug resistance and their regular therapies are becoming less effective. Unfortunately, new treatment options are scarce to virtually non-existent, as the standard of care for HIV patients remains a combination of different classes of antiretroviral medications at different stages of the infection. Driven by the strong belief that HIV patients, including those newly diagnosed, should receive the treatment they need as soon as possible, Vancouver, Washington-based biotech company CytoDyn Inc. (OTCQB: CYDY) has developed a new therapy, a viral-entry inhibitor called PRO 140, which is currently in Phase 3 clinical trials with very encouraging results so far.

The company has already filed a request with the Food and Drug Administration to grant PRO 140 a Breakthrough Therapy Designation as a therapy for HIV-1 treatment-experienced patients with virologic failure, according to a press release (http://nnw.fm/T2rtg). According to CytoDyn, and based on completed and ongoing clinical trials for the therapy, PRO 140 is a viable treatment options that addresses the unmet medical needs of HIV-1 patients whose regular antiretroviral medication has stopped working. Therefore, granting PRO 140 the designation of Breakthrough Therapy would aid a growing number of heavily treatment-experienced patients in gaining access to a novel therapy to complement or replace their conventional antiretroviral therapy.

If the FDA approves the request and gives PRO 140 the status of Breakthrough Therapy, this will help speed CytoDyn’s Biologics License Application process and bring the company one step closer to releasing the product on the market. The company’s CEO and President, Dr. Nader Pourhassan, said he was hopeful that the FDA would approve the request, as PRO 140 has successfully demonstrated its value as part of a combination therapy, the population for which this Breakthrough Therapy was filed. Moreover, PRO 140 has shown great results as a single agent therapy for some HIV patients (not all) with the R5 strain of human immunodeficiency virus.

Pourhassan said his company has already received several requests to allow patients continued access to PRO 140 so as to maintain viral suppression after the end of treatment in the Phase 3 combination therapy study. He explained that seven patients have already joined a rollover study to continue deriving clinical benefits from the therapy at the end of the 25-week Phase 3 study.  And in the single agent therapy study, CytoDyn currently has 10 HIV patients who’ve demonstrated suppressed viral load for more than two years.

Belonging to a new class of HIV/AIDS therapies called viral entry inhibitors and designed to protect healthy cells from infection, PRO 140 works by blocking the HIV co-receptor CCR5, therefore preventing viral entry. All clinical trials conducted so far concluded with encouraging results and have indicated that the new therapy does not have a negative impact on the normal immune functions associated with CCR5. A total of seven Phase 1 and 2 clinical trials have indicated that the new therapy can significantly reduce viral burden, while the recent Phase 2b trial showed that PRO 140 can actually prevent viral escape during a seven-month hiatus in conventional antiretroviral drug therapy.

For more information, visit the company’s website at www.CytoDyn.com

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