FDA approves Marshall Edwards' Ovature study design for phenoxodiol in ovarian cancer

By Lisa Kerner

Erie, Pa., May 16 - Marshall Edwards, Inc. said it has reached an agreement with the Food and Drug Administration, under the Special Protocol Assessment process, on the design of a pivotal study protocol for its investigational anticancer drug phenoxodiol.

The SPA process provides an agreement that the study design, including patient numbers, clinical endpoints and analyses, is acceptable to the FDA, according to a company news release.

Known as the Ovature study, the trial is designed to test the ability of phenoxodiol to restore sensitivity of late-stage ovarian cancers to carboplatin, a standard form of therapy for ovarian cancer.

Up to 470 patients will be enrolled and randomized to two treatment arms of the study: carboplatin plus phenoxodiol administered weekly intravenously, or carboplatin plus a placebo capsule administered 8-hourly on a continuous daily basis.

Ovature will take place at 60 sites in the United States, the United Kingdom, Europe and Australia.

Marshall Edwards said the primary endpoint of the trial is progression-free survival (death or disease progression, whichever comes first), with overall survival a secondary endpoint.

"We are pleased that the FDA has completed the SPA review process and that we have a mutually-agreed design that provides us with a clearly defined regulatory pathway for pursuing marketing approval of phenoxodiol," chairman Graham Kelly said in the release.

Phenoxodiol received fast track designation for platinum-resistant or refractory ovarian cancer from the FDA in 2004 based on phase 2 data.

While platinum-based drugs such as cisplatin and carboplatin are a standard form of chemotherapy in ovarian cancer, at least 85% to 90% of patients experience disease recurrence and a reduced response to platinums and other chemotherapies, the company said.

Marshall Edwards is a clinical development oncology company majority owned by biotechnology company Novogen.

Novogen, based in Sydney, Australia, is developing a range of therapeutics across the fields of oncology, cardiovascular disease and inflammatory diseases.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.