CytoDyn Files Pivotal Trial Protocol for HIV Monotherapy with FDA

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VANCOUVER, Washington, May 15, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that it has filed with the U.S. Food and Drug Administration (FDA) the pivotal trial protocol for leronlimab as a monotherapy for HIV patients.  The latest investigative monotherapy trial for HIV has now produced sufficient data for the Company’s Key Opinion Leaders to design a monotherapy pivotal Phase 3 trial. The objective of this trial is to assess the treatment strategy and clinical safety of using leronlimab subcutaneous (SC) 700mg weekly dose as single-agent induction therapy followed by leronlimab SC 525 or 700mg as maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection.

In this study, patients will receive a combination of existing retroviral regimen and leronlimab 700 mg SC for four weeks (the overlap phase) before shifting to weekly leronlimab 700mg monotherapy for 10 weeks (the monotherapy induction phase). Subsequently, patients will be randomized 1:1 to leronlimab 525mg (Group A) or leronlimab 700mg (Group B) for a 36-week monotherapy maintenance phase. Success with this monotherapy trial may allow the Company to file a BLA for label expansion in the event leronlimab receives FDA approval for HIV patients as a combination therapy with HAART.

Robert T. Schooley, M.D., Professor of Medicine, Division of Infectious Diseases, Vice Chair, Department of Medicine, Co-Director, Center for Innovative Phage Applications and Therapeutics, Senior Director, International Initiatives, University of California, San Diego, commented: “The development of simple and well tolerated oral daily treatment regimens have transformed the face of HIV disease for most patients with the virus. Nonetheless, there remain people for whom daily oral therapy is a challenge.  This group of patients has driven ongoing interest in the development of longer acting regimens that can obviate the requirement for daily oral dosing. PRO140, or leronlimab, is one of several agents under study with this goal in mind.”

Jacob P. Lalezari, M.D., Director of Quest Clinical Research, added: “As a longstanding investigator for CytoDyn, I have seen that many of our HIV positive patients express a preference for weekly subcutaneous leronlimab monotherapy and uniformly request extension treatment beyond 48 weeks in order to avoid returning to HAART therapy.  In the minority of subjects who are non-responders, we are heartened by the fact these folks can return to their original HAART regimen without difficulty.”

“The testimony of patients who have taken leronlimab as a monotherapy in our previous clinical trials is very clear; patients who respond to monotherapy simply love it, and after 48 weeks they ask for extension to continue on monotherapy. We have not seen any extension patients ask to return to their HAART regimen of pills,” noted Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.  “A monotherapy with leronlimab, if approved, may allow patients with pill fatigue to maintain a disciplined compliance regimen. In addition, it may provide patients concerned about the possibility of developing one or more drug class resistances, to potentially maintain a suppressed viral load without the typical side effects or toxicity associated with HAART,” concluded Dr. Pourhassan.

In the setting of HIV/AIDS, leronlimab belongs to a new class of therapeutics called viral-entry inhibitors; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab 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.

In the setting of cancer, research has shown that CCR5 likely plays a central role in tumor invasion and metastasis and that increased CCR5 expression is an indicator of disease status in several cancers. Moreover, research has shown that drugs that block CCR5 can block tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. CytoDyn is conducting additional research with leronlimab in the cancer setting and plans to initiate additional Phase 2 human clinical trials, in addition to triple-negative breast cancer, when appropriate.

The CCR5 receptor also appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be crucial for the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted “orphan drug” designation to leronlimab for the prevention of graft-versus-host disease (GvHD).

Marek Ciszewski, J.D.Edison, Inc.


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Globe Newswire: 13:20 GMT Wednesday 15th May 2019

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