HIV Community Closely Following Latest News About FDA Clinical Trials Of PRO 140

Infected patients could lead normal lives with possibly one dose a month

“The worldwide AIDS community could stop gulping down as many as 30 toxic pills a week to control their viral load. If our FDA trials continue to have such dramatic success, we can possibly offer those infected with HIV an opportunity to finally lead some type of normal life without a daily pill regimen. PRO 140, could be the first self-injectable HIV antibody on the global market. A once-a-week dose of two PRO 140 shots, one in each thigh, or possibly a once-a-month dose, can control their viral loads enough to lead a fairly normal life,” notes Nader Pourhassan, CEO, CytoDyn Inc., clinical developer of PRO 140.

“And now suddenly PRO 140 seems to be quite popular with news and comment sites that cater to the gay community; New Now Next, Edge Media Network (Fort Lauderdale, Dallas, Boston, Washington DC, Los Angeles), HIV Equal, Randy Report, POZ, and many others are closely following our news and press releases,” continues Pourhassan.

As documented in the Phase2b clinical trial, PRO 140 successfully kept viral loads suppressed for one month in 98% of HIV patients’ tested. And some HIV patients using PRO 140 are continuing to experience a completely suppressed viral load for the last 11 months. With positive results in the upcoming Phase 3 studies, PRO 140 could be commercial in 2017.

CytoDyn has a green light to start its Phase 3 clinical trial of PRO 140 at over 30 sites in the U.S. The Company may apply for a “breakthrough” designation of PRO 140 as “the first self-injectable antibody for HIV therapy.” If all goes well, CytoDyn could submit its NDA (New Drug Application) for final approval in November 2016. A previous fast-track candidate designation carries the possibility of accelerated approval. PRO 140 could be commercial in 2017 if it has positive results from these upcoming studies. Rate of success in this type of Phase 3 study is extremely high.

About CytoDyn
CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of Human Immunodeficiency Virus (HIV) infection. The Company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has finished Phase 2 clinical trials with demonstrated antiviral activity in man and is currently in Phase 3. PRO 140 blocks the HIV co-receptor CCR5 on T-cells which prevents viral entry. Clinical trial results thus far indicate that PRO 140 does not negatively affect the normal immune functions that are mediated by CCR5. Results from six Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. A recent Phase 2b clinical trial demonstrated that PRO 140 can prevent viral escape in patients during several weeks of interruption from conventional drug therapy. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV. For more information, visit www.cytodyn.com.

About PRO 140
PRO 140 belongs to a new class of HIV/AIDS therapeutics -- viral-entry inhibitors -- that are intended to protect healthy cells from viral infection. PRO 140 is a fully humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T-cells. PRO 140 blocks the predominant HIV (R5) subtype entry into T-cells by masking this required co-receptor, CCR5. Importantly PRO 140 does not appear to interfere with the normal function of CCR5 in mediating immune responses. PRO 140 does not have agonist activity towards CCR5 but does have antagonist activity to CCL5 which is a central mediator in inflammatory diseases. PRO 140 has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test subjects. PRO 140 has been designated a “fast track” product candidate by the FDA. The PRO 140 antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements as compared to daily drug therapies currently in use.