Now Enrolling for a Phase IIb Trial Treating Patients with HPV-Induced CIN2/3
Germantown, MD, USA (September 21, 2020) – Amarex Clinical Research, LLC, an NSF International company announces its client, Frantz Viral Therapeutics, LLC, is now enrolling for their Phase IIb pivotal clinical trial of Artesunate Vaginal Inserts for the treatment of biopsy-proven HPV-associated cervical intraepithelial neoplasia 2/3 (CIN2/3) in adult female patients.
Enrollment for the trial was initiated at the MD Anderson Harris Health System at LBJ Hospital in Houston, TX. Other clinical sites are being recruited to participate in this study.
Dr. Kazem Kazempour, Amarex President & CEO, stated, “Amarex’s team is pleased to continue working with Frantz Viral Therapeutics on the development of this product. Moving from our support of the successful Phase I trial that had strong safety and promising initial efficacy results, to a Phase IIb is a wonderful progression. HPV is a serious condition lacking adequate treatment and expedited R&D may prove lifesaving.”
Amarex is providing regulatory, safety, biostatistical, and general ad hoc support services for this Phase IIb clinical trial. Amarex is also providing regulatory support services to Frantz Viral Therapeutics on four total INDs, including ongoing Phase I trials treating anal intraepithelial neoplasia (AIN) and vulval intraepithelial neoplasia (VIN).
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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