Cytodyn Qualifies Pro 140 for Phase 3, Initiates 1st Clinical Site

CytoDyn Inc., a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, announced that the Company's QA/QC expert, Dr. Robert Schiff, has approved for release inventory suitable to satisfy CytoDyn's current Phase 3 trial. The Company's 25-week Phase 3 trial includes 300 patients and will require approximately 15,000 vials of PRO 140. They have also initiated their first clinical site for its Phase 3 trial.

"We are very pleased with Amarex Clinical Research's performance in initiating new sites for our current Phase 3 study," said Dr. Nader Pourhassan, President and CEO. "We believe that our recent $7.3 million equity raise will continue to support an expeditious commencement of our Phase 3 trial." �

In February 2014, the FDA provided certain guidance to the Company in order to qualify its existing inventory of PRO 140 to be used in future Phase 3 trials. In an effort to satisfy the qualification standards, the Company engaged several vendors to develop and perform numerous assays for qualification.

In 2012, CytoDyn purchased the PRO 140 program from Progenics, which included over 20kg of PRO 140 product and continues to maintain over 10kg of PRO 140 drug product for future use.�

Pourhassan was pleased that CytoDyn was able to qualify existing PRO 140 material for immediate use in their Phase 3 trial, which they believe will result in substantial material cost savings. Furthermore, their ongoing manufacturing activities to produce future Phase 3 and commercial PRO 140 material has resulted in identifying processes which have doubled the yield, thereby potentially reducing future manufacturing costs by as much as 50 percent. But the real reduction they are looking for is in HIV viral loads.

"Our primary end point for this Phase 3 trial is to reduce the viral load in HIV patients, who have experienced a viral load breakout, by 0.7log (a 5-fold drop) in one week with one 350mg dose of PRO 140," said Pourhassan, noting that a previous Phase 2a study completed in 2009 with HIV patients, demonstrated a viral load suppression of more than 1log (a more than 10-fold drop) in one week with one 324 mg dose of PRO 140 (nearly a 10 percent lower dosage).

"We believe the primary end point will be met if PRO 140 achieves half of what it previously demonstrated with a nearly 10 percent higher dosage than the previous study," said Pourhassan. "The last 24 weeks of this Phase 3 trial will allow patients to change their failing pill regimen to a new optimized regimen, coupled with a weekly 350mg injection of PRO 140. In summary, patients will receive 24 weeks of PRO 140 treatment along with a new optimized HAART regimen and we are optimistic about our results."

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 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.�

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.�

"This process could not have been so successful without the strong leadership of our chairman of the board, Anthony Caracciolo, former senior vice president of manufacturing for Gilead Sciences, Inc.," added Dr. Pourhassan.