pharma press release: Phenoxodiol/OVATURE

http://www.marketwatch.com/News/Story/Story.aspx?guid={40DC8D57-A36F-4DA7-A132-83469C5C89F8}&siteid=nbkh

Phase III Phenoxodiol Clinical Trial for Ovarian Cancer Continues

"The OVArian TUmor REsponse (OVATURE) trial is a major multi-center multinational Phase III clinical trial of orally administered phenoxodiol in combination with carboplatin in women with advanced ovarian cancer resistant or refractory to platinum-based drugs, to determine its safety and effectiveness when used in combination with carboplatin. More information on the trial can be found at http://www.OVATUREtrial.com.

The OVATURE trial is recruiting ovarian cancer patients whose cancer initially responded to chemotherapy, but has since become resistant or refractory to traditional platinum treatments. The trial consists of two double blind treatment arms. Patients in one trial arm are receiving weekly carboplatin and phenoxodiol. Patients in the other trial arm are also receiving weekly carboplatin, but a placebo (an inactive control pill) is substituted for phenoxodiol. Neither patients nor their doctors know to which trial arm the patients are randomly assigned.

A change from receiving platinum in the traditional dose pattern (every two to three weeks) to a weekly dosing regimen has been reported to provide a tumor response in some patients with recurrent ovarian cancer.(2-4) Thus, in addition to learning more about the safety and efficacy of phenoxodiol, researchers will learn more about the efficacy and safety of weekly carboplatin.

The primary outcome of the trial is the assessment of the relative time it takes for the ovarian cancer to progress. An analysis of interim results will be possible after patient recruitment to this study is completed and 95 patients have disease progression.
Patients are being recruited at hospital sites across the USA, UK, Europe and Australia. The trial design has been approved by the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) program, and provides for an interim analysis of the data, which, if statistically significant, can be used to support a request for accelerated marketing approval."