FDAnews
www.fdanews.com/articles/69576-cro-to-manage-trial-for-phenoxodiol-in-chemo-resistant-ovarian-cancer

CRO to Manage Trial for Phenoxodiol in Chemo-Resistant Ovarian Cancer

March 8, 2005

Marshall Edwards has appointed a major international clinical research organization (CRO) to project manage the final stages of the clinical program of the experimental anticancer drug, phenoxodiol.

The CRO will manage a new trial that seeks to produce data suitable for an application seeking marketing approval in the U.S. and elsewhere for phenoxodiol for the treatment of recurrent, chemo-refractory ovarian cancer.

This pivotal trial will be known as the OVATURE trial. Phenoxodiol is being developed as a drug that has anticancer activity in its own right, but also has a particular clinical benefit in being able to restore sensitivity to standard drugs in patients with cancer that has become unresponsive to such drugs. Ovarian, prostate and renal cancers are three such cancer types where phenoxodiol is being developed as a chemo-sensitizer.

In the case of patients with late-stage ovarian cancer, the development of resistance to standard drugs is a major barrier to the successful management of these cancers. Being able to restore sensitivity to platinum drugs in particular would represent a major breakthrough in the management of such cancers.