CytoDyn Provides Update on Dose Escalating Trial with Leronlimab for HIV Monotherapy for a Potential Pivotal Trial

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VANCOUVER, Washington, Aug. 14, 2019 (GLOBE NEWSWIRE) -- , (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today an update on its HIV dose escalating monotherapy trial.  HIV patients received dosages of 350 mg, 525 mg, or 700 mg of leronlimab once a week (229, 201, and 134 patients, respectively) with approximately 150 patients exhibiting sustained viral suppression at approximately one year of monotherapy. The rate of viral load suppression post-10 weeks of monotherapy was 68%, 94%, and 85% with 350 mg, 525 mg, and 700 mg, respectively. The failure criteria post-10 weeks was three increasing viral loads over 50 cp/mL or one viral load over 1000 cp/mL.

"These results position us well for our upcoming face-to-face meeting with the FDA regarding our pivotal monotherapy trial protocol,” stated CytoDyn President and CEO, Nader Pourhassan, Ph.D.  "Even more impressive is the long-term durability of the antiviral response in some patients in our other trials, with six patients reaching three years successfully on monotherapy and another four patients nearing the five-year mark for suppressed viral load," he added. “Recent data suggests that the receptor occupancy test being fine-tuned by Dr. Bruce Patterson may effectively identify potential responders to monotherapy at the time of screening, thereby potentially raising the success rate in the monotherapy program,” Dr. Pourhassan concluded.    

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; 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 plays an important role in tumor invasion and metastasis.  Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by >98% in a murine xenograft model. CytoDyn is therefore conducting a Phase 2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.  Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additional clinical studies when appropriate. 

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be important in 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. 

More news and information about CytoDyn Inc.

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Globe Newswire: 11:00 GMT Wednesday 14th August 2019

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