With FDA Approval, PRO 140 Could Make HAART A Weekly Injection

After decades of taking multiple pills day-in and day-out, the HIV infected could finally take a break, substituting injections for pills. CytoDyn Inc. has found great success with the clinical development of PRO 140, an antibody for HIV.

"Essentially, if PRO 140 is FDA approved, the infected person could finally take a break and go on a vacation without having to remember their pills, and the exact times to take them each day," said Nader Pourhassan, President and CEO of CytoDyn Inc. Some have been on their multiple pill regimen day-in and day-out for decades. Upon FDA approval, all they will need is a gentle reminder to inject a weekly dose of PRO 140 every seven days. They would be delighted to take a break from the stress of all those pills. We believe large numbers of HIVers are very much in need of PRO 140," states Nader Pourhassan, President and CEO of CytoDyn Inc., clinical developer of PRO 140, an anti-body under development for HIV.

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. �

Additionally, the Company recently announced that eleven HIV patients receiving PRO 140 monotherapy in an extension study have now successfully reached one year of maximal virologic suppression. These patients substituted their daily Highly Active Antiretroviral Therapy (HAART) regimen with weekly painless subcutaneous injections of PRO 140. These eleven patients have experienced successful monotherapy with PRO 140 for a period ranging from 12 to 15 months to date.

"We are very pleased to report maximal virologic suppression with PRO 140 monotherapy in 11 out of 14 HIV-1 patients who are participating in this treatment-substitution study," said Jacob P. Lalezari, M.D., the principal investigator of the PRO 140 Phase 2b trial and extension study from Quest Clinical Research. "The durability of the response to PRO 140 monotherapy over at least a one year period is remarkable. In addition, PRO 140 appears well tolerated in all patients treated to date."

CytoDyn is currently conducting a pivotal 25-week Phase 3 FDA trial. Final results are expected in the fourth quarter of 2016. The Company plans to bring the product to market in early 2017.

For more information, visit www.cytodyn.com