The U.S. Food and Drug Administration (FDA) cleared Nuvectis Pharma’s (NASDAQ:NVCT) Investigational New Drug Application (IND) for NXP800, which includes the Phase 1 clinical trial protocol.
The NXP800 Phase 1 clinical trial is comprised of two parts, a Phase 1a dose escalation study to be followed by the Phase 1b expansion study.
The company said that the Phase 1a is currently ongoing in the United Kingdom, with this IND clearance, the clinical sites in the United States will now be included in the trial.
Ron Bentsur, Chairman and Chief Executive Officer, said, "The FDA approval of the IND for NXP800 marks an important milestone towards our mission of developing novel treatments for unmet medical needs in oncology. We look forward to building on the substantial interest that NXP800 has garnered in the medical community and to working with leading clinical centers in the U.S. and the U.K. on this important project.”
The Phase 1b expansion study which will evaluate initially in Arid1a-mutated ovarian clear cell carcinoma and ovarian endometrioid carcinoma, is expected be initiated in early 2023.
Nuvectis Pharma is trading high 10 percent at $12.11
