FORT LEE, NJ - Nuvectis Pharma, Inc. (NASDAQ: NVCT) has announced preliminary results from its Phase 1b clinical trial of NXP800, showcasing encouraging data in the treatment of platinum-resistant, ARID1a-mutated ovarian cancer. The trial, which is currently underway in the United States and the United Kingdom, has revealed a 33% response rate and a 100% disease control rate among the patients evaluated for efficacy.
The study is focused on a severe form of ovarian cancer that currently lacks effective treatments, with patients having a median life expectancy of around one year. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the NXP800 program for this particular cancer type.
According to Nuvectis Chairman and CEO Ron Bentsur, the initial data includes a partial response (PR) and a complete response (CR) of non-target lymph node disease in one patient, with stable disease observed in others. These patients had previously undergone multiple lines of systemic chemotherapy, including platinum-based regimens.
The preliminary data also highlighted adverse events, with three of the four patients experiencing Grade 4 thrombocytopenia, a condition involving a severe decrease in platelets. These events were transient, and dosing management procedures have been implemented to manage side effects and improve patient retention.
NXP800, an oral small molecule and potential first-in-class GCN2 kinase activator, is also being evaluated for the treatment of cholangiocarcinoma, for which it has received Orphan Drug Designation from the FDA. The drug completed a Phase 1a dose-escalation study in the first half of 2023.
The biopharmaceutical company is developing NXP800 and another drug candidate, NXP900, aiming to address serious oncological conditions with unmet medical needs. The information provided is based on a press release statement from Nuvectis Pharma.
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