Primary Endpoint Successfully Achieved in a Phase 2b/3 Study for Treatment of HIV-1 Subjects
Germantown, MD, USA - Amarex Clinical Research helped a client successfully meet their primary endpoint in a Phase 2b/3 clinical trial of treatment-experienced HIV-1 patients. This trial was designed to assess efficacy, clinical safety, and tolerability parameters of the anti-body based product. Top line results demonstrated statistical significance for the primary efficacy endpoint of the trial.
Amarex provided all clinical trial services for this study, including project management, study design, clinical monitoring, data management, statistics, pharmacovigilance, medical writing, and regulatory.
Dr. Kazem Kazempour, President and CEO of Amarex, has worked within the area of HIV/AIDS research for over 30 years and states that “Innovative therapies are urgently needed for treatment-experienced patients with drug-resistant HIV, and this product appears to have definite utility. We are pleased to have met the primary endpoint, and we will continue our research as we move through this two-part trial.”
About Amarex Clinical Research
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 Submissions, Applications and Submissions to international Health Authorities, GxP Compliance Audits, Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management and General Consulting. Amarex has taken clients’ products through the entire approval process from writing the initial product approval strategy to the marketing approval application with a growing list of approved products. Amarex is committed to cost effective, high quality clinical product development.
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