Amarex in the Fight Against COVID-19
Germantown, MD, USA (September 02, 2020) – In early March, Amarex Clinical Research, LLC, an NSF International company began work on a potential treatment for COVID-19. An Amarex client had an immune response modulating monoclonal antibody product in clinical development for HIV that was quickly re-purposed for COVID-19 treatment. Amarex managed to get U.S. FDA approval for compassionate use of the product to treat severely ill patients in a New York City hospital. Soon thereafter, Amarex initiated multiple projects for other clients’ therapeutic, prophylactic, and diagnostic products for COVID-19. Amarex achieved several emergency IND approvals and began several COVID-19 clinical trials. In parallel, Amarex submitted several Emergency Use Authorization (EUA) requests for the use of new COVID-19 virus diagnostics, and an expanded access approval for use of a device to filter cytokines from patients’ blood.
Since March, Amarex has helped 16 companies on 32 separate projects for COVID-19 products: 5 devices/diagnostics, 7 drug therapies, 2 biologic therapies, and 2 vaccines. We have executed applications and requests for: compassionate use, emergency use, EUA, Clinical Trial Agreement, pre-IND meeting, eIND, fast track designation, and expanded access in the U.S., UK, Europe, and Asia.
Dr. Kazem Kazempour, President & CEO, stated, “Over these past six months Amarex staff has worked tirelessly to obtain expedited regulatory approvals and to initiate clinical trials that rapid test for COVID-19, treat patients with the virus, and develop products for COVID-19. I am amazed and grateful for the efforts of Amarex colleagues on behalf of patients and our clients.”
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. Their combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides 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 assisted by quality, cost-efficient services. For more information visit www.amarexus.com.
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