Zentalis Pharmaceutical Studies on Partial Clinical Hold Following Deaths

By Adriano Marchese

Zentalis Pharmaceuticals said the Food and Drug Adminstration has temporarily halted a number of studies for its cancer treatment following two deaths in one of them.

The clinical-stage biopharmaceutical said it has placed a partial clinical hold on studies for its drug, Azenosertib.

In particular, the holds were applied to the phase 1 ZN-c3-001 dose-escalation study in solid tumors, the phase 2 ZN-c3-005 study in platinum-resistant ovarian cancer, and the phase 2 ZN-c3-004 study in uterine serous carcinoma.

Chief Executive Kimberly Blackwell said the company is working with regulators to resolve the partial clinical hold as quickly as possible.

"Over 500 patients have been treated with Azenosertib monotherapy to date, and we believe that our data indicate a favorable therapeutic index that could potentially offer meaningful benefits," Blackwell said.

Write to Adriano Marchese at [e-mail]

(END) Dow Jones Newswires

06-18-24 0746ET