By Zaeem Shoaib
Nuvectis Pharma shares fell steeply after updated data from its early-stage study evaluating NXP800 to treat an aggressive type of ovarian cancer showed that a change in the dosing schedule only minimized the severity of a condition in patients that causes abnormally low amount of platelets.
Shares fell 44% to $5.99 in recent trading. The stock is down almost 39% this year.
Earlier this year, the interim data reported for the Phase 1b study in patients with platinum resistant ARID1a-mutated ovarian cancer included four patients, of which three experienced Grade 4 thrombocytopenia. In the eight patients treated with NXP800 using an intermittent dosing schedule, the highest grade of thrombocytopenia observed was Grade 2.
The NXP800 development program in this type of ovarian cancer was granted fast-track designation by the U.S. Food and Drug Administration.
Other than thrombocytopenia, the most common treatment emergent adverse events included nausea, fatigue, vomiting, diarrhea and constipation, the majority of which being Grade 1-2, the company said.
Nuvectis said antitumor activity was observed in 11 efficacy-evaluable patients, with best responses including one patient with an unconfirmed partial response and six patients with stable disease, including tumor shrinkage.
"The antitumor activity observed despite patients' advanced disease and extensive pre-treatment, while controlling for thrombocytopenia, is promising. However, it is clear that we need to increase the dose intensity to drive more efficacy in the next set of patients," Chief Executive Ron Bentsur said.
Bentsur said the company is enrolling patients into a cohort of up to 10 to 12 additional patients utilizing a higher dosage on an intermittent dosing schedule, which is expected to be the last cohort in this Phase 1b study.
Nuvectis expects to provide additional clinical data from the study in the second quarter of 2025, he added.
Write to Zaeem Shoaib at zaeem.shoaib@wsj.com
(END) Dow Jones Newswires
November 14, 2024 10:31 ET (15:31 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.
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