EATG » Results of CytoDyn’s PRO 140 CD01 trial and extension study published in HIV Clinical Trials

Results of CytoDyn’s PRO 140 CD01 trial and extension study published in HIV Clinical Trials

Data provide support for PRO 140 as long-acting, HIV-1 maintenance therapy

VANCOUVER, Washington, May 24, 2018 — CytoDyn Inc. (OTC.QB:CYDY) announces that results from its CD01 Phase 2b clinical trial and extension study showing the potential of PRO 140, its novel humanized CCR5 monoclonal antibody, as a long-acting, single-agent maintenance therapy for HIV-1 infected patients were published in the peer-reviewed journal HIV Clinical Trials.

All HIV-1 infected patients enrolled in the CD01 Phase 2b trial exhibited suppressed viral load on antiretroviral therapy (ART) prior to enrolling into this trial.  Patients were administered 350 mg of PRO 140 weekly by subcutaneous injections as a single-agent therapy. More than half of enrolled patients (21 of 39) reached the trial endpoint of 14 weeks without virologic failure (two consecutive HIV-1 RNA levels of ≥ 400 copies/ml). Of the 18 patients considered non-responders, all achieved re-suppressed viral load upon resuming their prior ART regimen. PRO 140 was well tolerated with no treatment-related significant adverse events or study discontinuations due to adverse events.

“Notably nearly all trial patients who successfully reached the trial endpoint requested to continue into an extension study,” said Nader Pourhassan, Ph.D., CytoDyn President and Chief Executive Officer. “A portion of participants in the extension study have now exhibited HIV suppression for more than three years, providing support for PRO 140 as a potential important weapon in suppressing viral load in those infected with HIV-1.”

The article was authored by CytoDyn Inc. and Amarex Clinical Research scientists and PRO 140 discoverer Paul J. Maddon, MD, Ph.D.

About PRO 140

PRO 140 belongs to a new class of HIV/AIDS therapeutics – viral-entry inhibitors – that is intended to protect healthy cells from viral infection. PRO 140 is a 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 toward CCR5 but does have antagonist activity to CCL5, which is a central mediator in inflammatory diseases. PRO 140 has been the subject of eight 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 by the FDA. The FDA also granted orphan drug designation to PRO 140 for the prevention of graft-versus-host disease (GvHD). The PRO 140 antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

About CytoDyn

CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of HIV infection. The Company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has completed Phase 2 clinical trials with demonstrated antiviral activity in humans and is currently in Phase 3 development. 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 eight 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 months 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, inflammatory indications where CCR5 and its ligand CCL5 may be involved. For more information on the Company, please visit http://www.cytodyn.com.

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