First Patient Enrolled Under Newly Modified Protocol in CytoDyn's Phase 3 PRO 140 Combination Study in HIV

CytoDyn Inc., a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces the enrollment of the first patient under a recently modified protocol in the Company's Phase 3 combination study with PRO 14O (humanized monoclonal antibody to CCR5).

The�modified protocol has been cleared by the U.S. Food and Drug Administration (FDA) and features a 50 percent reduction in enrollment to 150 subjects and relaxed enrollment criteria allowing HIV-infected subjects to enter the study before confirmation of the R5 strain.

"We expect to enroll subjects at a much faster pace under this newly-modified�protocol, which allows for those with HIV viral load over 400 cp/mL to be treated with PRO 140 and OBT without waiting for their tropism test results," said Nader Pourhassan, Ph.D., CytoDyn President and CEO. "The prior protocol required that study subjects continue on failed�ART while waiting for validation of the R5 strain, which could take several weeks and was a deterrent to enrollment. We have shown that PRO 140 is safe for HIV-infected patients with dual mix or X4 exclusive strains of HIV in our completed Phase 2b monotherapy clinical trial."

PRO 140 has proven effective in managing the viral load of people infected with the R5 strain of HIV, which accounts for approximately 67 percent of infected Americans and up to 85 percent of those newly diagnosed.

This first enrolled patient under the recently modified trial protocol is in addition to patient enrollment under the previous protocol, in which the first patient to have successfully completed the trial was transitioned to a compassionate use protocol, at the request of the treating physician, so as to continue on PRO 140 therapy with a suppressed viral load.

The multicenter, randomized Phase 3 combination study is evaluating the efficacy and safety of PRO 140 combined with standard of care antiretroviral therapy (ART) in treatment-experienced HIV-infected patients who are failing their ART therapy. The study is divided into two parts, with part one as a double-blind treatment period in which study subjects are randomized and treated with either PRO 140 or placebo weekly subcutaneous injections in combination with their failing ART regimen for up to one week.

During this week, each subject is evaluated for HIV-1 genotypic drug resistance and a new optimized ART regimen is developed. In the second part of the study, subjects continue treatment with either PRO 140 or placebo in combination with the optimized background therapy (OBT) for up to an additional three weeks, when the HIV-1 co-receptor tropism assay results (i.e., determination of R5 strain) are available. At this time, subjects will move to a 24-week, open-label period. Only subjects with R5 virus will be treated with PRO 140 and OBT, whereas subjects with X4 or dual/mixed-tropic virus will receive OBT alone during the 24-week open-label treatment period.

"We are excited to quickly enroll our first subject following FDA-clearance of the modified protocol and we anticipate being able to announce top line findings on the primary endpoint in 2017," Dr. Pourhassan added.