The UK Health Authorities Approve COVID-19 Clinical Trial to Treat Immunocompromised Patients
Germantown, MD, USA (May 07, 2020) – On April 27, Amarex Clinical Research, LLC, an NSF International company, achieved approval from the UK health authorities ((Medicines and Healthcare products Regulatory Agency (MHRA) as well as central ethical committee, “Health Research Authority (HRA)”) to conduct a Phase 2 clinical trial of a recombinant human protein product, on behalf of its client, as a treatment for a subpopulation of patients with COVID-19. This Clinical Trial Application (CTA) was prepared and submitted to MHRA by Amarex’s Regulatory Affairs department within a very short period of time. Patient enrollment is targeted to begin next week, and Amarex will be managing the study for the client.
Dr. Kazem Kazempour, Amarex President & CEO, stated, “This is a patient population with a high unmet medical need. It is rewarding for Amarex, a U.S. headquartered CRO, to assist with this international effort by obtaining emergency approval from the UK regulatory agencies for this clinical trial, using a product from a European company that will be used in a multi-regional clinical trial.”
This will be Amarex’s third emergency approval within the past month for therapeutic products treating COVID-19. The other two COVID-19-related approvals include a monoclonal antibody drug and a blood filtration device, both of which are in clinical trials in the US. Amarex has also submitted multiple drug and device applications to the US FDA and other health regulatory agencies for either treatment or diagnosis of COVID-19.
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.
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