The Independent Data Monitoring Committee(IDMC) constituted to oversee the conduct of the Phase III OVArian TUmorREsponse (OVATURE) Trial, has recommended continuation of the study.
The OVATURE trial is a major multi-center international Phase III clinicaltrial of orally-administered investigational drug phenoxodiol incombination with carboplatin in women with advanced ovarian cancerresistant or refractory to platinum-based drugs, to determine its safetyand effectiveness when used in combination with carboplatin.
The IDMC, which met in Chicago at the Annual Meeting of the AmericanSociety of Clinical Oncology (ASCO), is responsible to ensure that patientsrecruited to the study are not exposed to unnecessary safety risks, thatthe study continues to meet its clinical objectives, and that it is runaccording to the required standards of Good Clinical Practice. Followinga scheduled review of safety and efficacy data, the Committee hasrecommended that the study remains open and continue as planned towards itsaccrual target of 340 patients.
The OVATURE trial is recruiting ovarian cancer patients whose cancerinitially responded to chemotherapy, but has since become resistant orrefractory to traditional platinum treatments. Patients are beingrecruited at clinical sites across U.S., United Kingdom, Europe andAustralia. Currently, more than 25 sites in the U.S., 20 sites inEurope/UK, and six sites in Australia are participating in this clinicalstudy.
The OVATURE trial has been approved by the U.S. Food and DrugAdministration (FDA) under a Special Protocol Assessment (SPA) program,indicating that the study's design, clinical endpoints, and statisticalanalyses are acceptable to FDA. The protocol provides for an interimanalysis of the data, which, if statistically significant, can be used tosupport a request for accelerated marketing approval. An analysis ofinterim results will be possible after the targeted patient recruitment tothis study is completed and 95 patients have disease progression. TheOVATURE trial is sponsored by Marshall Edwards, Inc. (NASDAQ: MSHL), thedeveloper of phenoxodiol.
Patients and caregivers who are interested in learning more about theOVATURE trial should visit a website for this study atwww.OVATUREtrial.com.
About Phenoxodiol:
Phenoxodiol is being developed as a chemosensitizing agent in combinationwith platinum drugs for late stage, chemoresistant ovarian cancer and as amonotherapy for prostate and cervical cancers.
