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Amarex Co-Authors Paper on Emergency Use Treatment of Leronlimab for COVID-19

Germantown, MD, USA (May 28, 2020) – In mid-March, Amarex worked with client CytoDyn to prepare, submit, and achieve FDA approval for emergency use of CytoDyn’s drug leronlimab as a treatment for severe cases of COVID-19. Since then, over 50 patients in a New York hospital have been treated with leronlimab. Initial results appear to show that leronlimab restores immune homeostasis, reduces plasma viral load, and reverses hyperimmune activation and inflammation in critically ill COVID-19 patients.

Subsequently, Amarex’s staff co-authored a research paper, in conjunction with CytoDyn, analyzing the results of the leronlimab treatment. The paper has been shared with the World Health Organization (WHO). In addition, data from this article was published online in Nature on May 12. Amarex President & CEO, Dr. Kazem Kazempour, and Senior Vice President of Clinical Operations, Dr. Kush Dhody, are both contributing authors on the paper. The paper is titled Disruption of the CCL5/RANTES-CCR5 Pathway Restores Immune Homeostasis and Reduces Plasma Viral Load in Critical COVID-19, and is available for review at https://www.researchsquare.com/article/rs-26517/v1.

Amarex simultaneously helped CytoDyn with two 'rush' IND applications in order to more definitively assess leronlimab’s effectiveness as a COVID-19 treatment in serious COVID-19 cases and in mild-to-moderate COVID-19 cases. Both applications received approval from the FDA and these studies are currently enrolling subjects. Amarex is providing clinical trial management services for these trials.

Dr. Kazem Kazempour stated, “Considering the novelty of COVID-19, conducting this initial research and achieving these results in less than two months is remarkable. The Amarex team is encouraged by these successes and excited to be directly involved in finding solutions to the COVID-19 pandemic.”

About CytoDyn Inc.

CytoDyn Inc. is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.

About Amarex Clinical Research, LLC, an NSF International company

Amarex Clinical Research, LLC, an NSF International company, is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost-efficient services. For more information visit www.amarexus.com.

Amarex Contact:
Patrick J. Burke
Business Development
patrickb@amarexcro.com

20201 Century Blvd., Fourth Floor
Germantown, MD 20874 USA
301 528 7000
www.amarexus.com

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