Nuvectis receives orphan drug designation for
cholangiocarcinoma
therapy

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Nuvectis receives orphan drug designation for cholangiocarcinoma therapy
Preview
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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The study is designed to explore the drug candidate’s clinical activity as a potential treatment for platinum-resistant,
ARID1a
-mutated ovarian carcinoma.
NuvectisNuvectis has already received fast track designation for the NXP800 development programme.
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 carcinomas
ARID1a
-mutated ovarian, endometrial and gastric carcinomas, as well as
cholangiocarcinoma
.
“This orphan drug designation is an important milestone in our journey toward our mission of developing NXP800 for the treatment of serious conditions of unmet medical need in
oncology
.”
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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适应症
胆管癌,胃肠道肿瘤,恶性胸膜间皮瘤
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