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Amarex Submits a Biologics License Application (BLA) on Behalf of its Client, CytoDyn, for a Product to Treat HIV Patients

Germantown, MD, USA (April 28, 2020) – Amarex Clinical Research, LLC, an NSF International company, announces today that they submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the product leronlimab (PRO 140), on behalf of their client, CytoDyn. The application was finalized with the submission of the clinical and CMC (chemistry, manufacturing and controls) sections of the BLA. The drug will be administered as a combined therapy in the treatment of HIV.

Amarex was involved in preparation of this BLA, providing biostatistics, medical writing and regulatory services. Kazem Kazempour, Ph.D., Co-Founder, President and Chief Executive Officer of Amarex said, “We have worked with our client CytoDyn for a number of years on PRO 140, and we are pleased to see that, after much hard work and dedication, we are moving towards marketing approval. Our clinical trials have been successful thus far, with PRO 140, and we hope to have the same result for ongoing trials of this drug in other indications.”

Leronlimab (PRO 140), a monoclonal antibody product, is also undergoing testing as an investigation new drug in other therapeutic areas, including cancer, Graft versus host disease (GvHD), immunology and Coronavirus Disease (COVID-19).

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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