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FDA accepts investigational new drug application for cantrixil to treat ovarian cancer

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The FDA accepted an investigational new drug application for cantrixil, which is in development as an intraperitoneal therapy for patients with ovarian cancer.

Consequently, a first-in-human phase 1 study intended to evaluate cantrixil (TRX-E-002-1, Novogen) in patients with ovarian cancer may proceed as planned. The study is expected to begin in the fourth quarter of this year.

“We are grateful to the FDA for their thorough and comprehensive review of our submission, and we are pleased to have their approval to move forward with the study,” James Garner, MA, MBA, MBBS, BSc (Hons), SAFin, CEO of Novogen, said in a company-issued press release.

Novogen is collaborating with Quintiles, a contract research organization, to make the necessary submissions to human research ethics committees at each of the participating study sites.

If approved, cantrixil could be indicated as an intraperitoneal chemotherapy for use alone or in combination with other agents for cancers of the abdominal cavity, such as ovarian, uterine, colorectal or gastric carcinomas, according to the company-issued press release.