PRO 140 shows promise in HIV

CytoDyn reports HIV patients approaching 17 months of complete viral suppression with PRO 140 monotherapy

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VANCOUVER, Wash.—CytoDyn Inc., a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, announced that its ongoing extension study of PRO 140 monotherapy in a cohort of HIV-infected patients has shown complete viral-load suppression for well over a year with some patients approaching 17 months. The company believes that complete virologic suppression through treatment with a single agent, PRO 140, a safe and efficacious antibody, rather than through the widely used HAART combination therapy, could present a significant opportunity to treat HIV patients. Based on these monotherapy results, the company plans to file a second Phase 3 protocol for PRO 140 monotherapy with the U.S. Food and Drug Administration (FDA). CytoDyn is currently conducting a pivotal Phase 3 trial for PRO 140 as an adjunct therapy with expected commercialization in 2017.

Dr. Nader Pourhassan, CytoDyn’s President and CEO commented that: “We believe PRO 140 can effectively address adherence to a complex therapeutic regimen, which is a major challenge in today’s HIV world. Only about 25 percent of HIV patients in the U.S. have a completely suppressed viral load. A large contributor to this problem is due to patients’ inability to adhere to a highly structured schedule to take their medications on a specific timetable every day of their lives (Anti-Retroviral Therapy or ART). PRO 140 is administered as a simple, weekly subcutaneous injection and could be the solution to this very serious adherence problem. Moreover, our clinical trials to date have clearly indicated that PRO 140 is safe and efficacious without the side effects and toxicities experienced in the current ART therapeutic regimen. We are optimistic about our current and upcoming trials of PRO 140 and believe our antibody presents a compelling alternative or adjunct therapy to ART for HIV patients.”

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 and to pursue non HIV indications where CCR5 and its ligand CCL5 may be involved.

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.

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