Nuvectis receives orphan drug designation for cholangiocarcinoma therapy
2023-08-18
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来源: Pharmaceutical Technology
Cholangiocarcinoma accounts for approximately 3% of all gastrointestinal malignancies. Credit: Explode / Shutterstock.com.
Nuvectis Pharma has received orphan drug designation from the US Food and Drug Administration (FDA) for NXP800 to treat cholangiocarcinoma.
NXP800, a small molecule taken orally, is currently being assessed in a Phase Ib clinical trial.
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View allCompanies IntelligenceNuvectis Pharma IncSRC IncView all
The study is designed to explore the drug candidate’s clinical activity as a potential treatment for platinum-resistant, ARID1a-mutated ovarian carcinoma.
It is also developing another drug candidate, NXP900, a new small molecule inhibitor targeting the SRC/YES1 kinases.
The FDA has cleared the IND for NXP900 and a Phase Ia dose escalation trial is yet to commence.
Nuvectis chairman and CEO Ron Bentsur stated: “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 carcinomasARID1a-mutated ovarian, endometrial and gastric carcinomas, as well as cholangiocarcinoma.
Cholangiocarcinoma is a biliary tract cancer, which emerges in the biliary tree epithelium.
With an annual incidence of nearly 8,000 to 10,000 in the US, it accounts for around 3% of all gastrointestinal malignancies.
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