PRO 140 Could Soon Offer Self-Injectable HIV Antibody

The HIV community is closely following the latest news about FDA clinical trials of PRO 140. Early results indicate that 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 regime," said Nader Pourhassan, CEO, CytoDyn Inc., clinical developer of PRO 140. "This 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,"

As documented in the Phase2b clinical trial, PRO 140 successfully kept viral loads suppressed for one month in 98 percent 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.

"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," continued Pourhassan.

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.

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