Nuvectis Pharma Says FDA Grants Orphan Drug Designation To NXP800 For Cholangiocarcinoma

(RTTNews) - Biopharmaceutical company Nuvectis Pharma, Inc. (NVCT) announced Thursday that NXP800 was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of cholangiocarcinoma.

NXP800 is an oral small molecule with a novel mechanism of action that has demonstrated robust activity in several preclinical cancer models, including ARID1a-mutated ovarian, endometrial and gastric carcinomas, as well as cholangiocarcinoma.

The clinical activity of NXP800 is currently being evaluated in a Phase 1b clinical trial in patients with platinum resistant, ARID1a-mutated ovarian carcinoma, with additional diseases planned for clinical investigations.

Cholangiocarcinoma is a cancer of the biliary tract originating in the epithelium of the biliary tree accounting for approximately 3% of all gastrointestinal malignancies, with an annual incidence of approximately 8,000 to 10,000 in the United States.