Dr. Susana Banerjee (The Royal Marsden NHS Foundation Trust, UK), will be the ENGOT and Global Clinical Trial Lead
Dr. Shannon Westin (MD Anderson Cancer Center, Houston, TX) and Dr. Ramez Eskander (University of California San Diego, San Diego, CA) will be the co-GOG Foundation Trial Leads in the US
Fort Lee, N.J., Jan. 04, 2023 (GLOBE NEWSWIRE) — Nuvectis Pharma, Inc. (NASDAQ:NVCT) (“Nuvectis” or the “Company”), a clinical stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced a collaboration with the European Network of Gynecological Oncology Trial Groups (“ENGOT”) and the GOG Foundation, Inc. (“GOG-F”) to conduct the NXP800 Phase 1b clinical trial in ARID1A-mutated, ovarian clear cell and endometroid carcinomas in Europe and the United States.
“We are honored to collaborate with the ENGOT and GOG-F on this very important clinical trial. ENGOT and GOG-F are the world’s premier gynecology oncology clinical trials consortia, representing some of the leading medical centers and having spear-headed several drug approvals in the field, including the 2 PARP inhibitors for the treatment of BRCA-mutated ovarian cancers, Olaparib (Astra Zeneca) and Niraparib (GSK), as well as the antibody-drug conjugate Tivdak (Seattle Genetics), which is approved for cervical cancer,” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. Mr. Bentsur continued, “As our Phase 1a dose-escalation study in patients with advanced solid tumors is nearing completion, we have begun preparing for the start of the Phase 1b trial alongside the consortia’s world renowned experts who provide guidance into key design elements of the study protocol and access to top clinical centers.”
Mr. Bentsur added: “We believe that the high-quality discovery and lead optimization program at the Institute of Cancer Research, the robust preclinical proof of concept, the recent Fast Track Designation by the U.S. FDA, and now the collaboration with ENGOT and GOG-F, bode well for the future of NXP800. Clinical data from the ongoing Phase 1a trial to date suggest that the emerging clinical profile of NXP800 can provide a good balance between systemic exposure, pharmacodynamic activity and tolerability, and we look forward to the initiation of the Phase 1b trial in the next few months.”
About ENGOT
ENGOT is a research network of the European Society of Gynecological Oncology (ESGO) and was founded in Berlin in October 2007. Currently, ENGOT consists of 21 trial groups from several European countries that perform cooperative clinical trials. The ultimate goal of ENGOT is to bring the best treatment to gynecological cancer patients through the best science, and enabling every patient in every European country to access a clinical trial.
The ENGOT reference number for the Phase 1b clinical trial of NXP800 is ENGOT-GYN5/NCRI/NXP800-101.
About The GOG Foundation, Inc. (www.gog.org)
The GOG Foundation is a not for profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis, and distribution of results. The GOG Foundation is the only clinical trialist group in the United States that focuses its research on patients with pelvic malignancies, such as cancer of the ovary (including surface peritoneal malignancies), uterus (including endometrium, soft tissue sarcoma, and gestational trophoblastic neoplasia), cervix, vagina, and vulva. The GOG Foundation is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, oncology nurses, biostatistitions (including those with Expertise in bioinformatics), basic scientists quality of life experts, data managers, and administrative personnel.
About GOG Partners
Supported by industry, GOG Partners is structured to work directly with pharmaceutical organizations and operate clinical trials outside the National Cancer Institute (NCI) framework. The GOG Partners shares the same mission of the GOG Foundation dedicated to transforming the care in Gynecologic Oncology. By providing an alternative venue for patient accrual and site infrastructure support, GOG Partners has helped provide additional trials and opportunities for patients outside the national gynecologic clinical trials network.
The GOG reference number for the Phase 1b clinical trial of NXP800 is GOG-3087.
