Amarex Executes Three Rush COVID-19 Related Submissions to the FDA in March
Germantown, MD, USA (March 30, 2020) - On March 27, Amarex executed a rush submission to the U.S. FDA of an Emergency Use Authorization (EAU) for a PCR-based IVD for the rapid detection of the coronavirus (SARS-CoV-2). The FDA quickly acknowledged receipt of the EUA and Amarex awaits a decision. The IVD has been through the regulatory approval process in Korea and Amarex and its client are therefore hopeful for a rapid FDA approval result.
On March 25, Amarex also executed a rush submission to the U.S. FDA for a Compassionate Use Approval (CUA) for treatment of COVID-19 patients with a device that is currently in testing under an existing Investigational Device Exemptions (IDE) for a different medical condition. Based on the mechanism of action there is reason to believe that the device may be an effective treatment for COVID-19 patients displaying serious symptoms. Amarex prepared the submission in a matter of days, which included writing a new clinical trial protocol. Amarex’s client expressed notable appreciation in an email to President & CEO, Dr. Kazem Kazempour, stating that ” ….I count myself lucky to work with such caring individuals. Thanks for being some of the most interesting and high performing people I’ve ever worked with.”
Finally, in early March, Amarex executed a rush submission of an Investigational New Drug (IND) amendment to add COVID-19 as a new indication under an existing IND owned by the company CytoDyn for their monoclonal antibody product, leronlimab. The product is currently being tested for HIV infection and has the potential to modulate the life threatening ‘cytokine storm’ sometimes seen in COVID-19 patients. CytoDyn received rapid approval from the FDA for emergency treatment of an initial cohort of seven extremely ill COVID-19 patients. On March 27, CytoDyn released initial positive results in the first four patients treated, having seen a reduction of the hyper-immune response three days following treatment initiation.
CytoDyn 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 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 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.
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