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First Patient Enrolled in Europe in Ovature Phase III Ovarian Cancer Trial
Date:8/27/2007

hen used in combination with the chemotherapy drug, carboplatin. Ovarian cancer patients whose cancer initially responded to chemotherapy, but has since become resistant or refractory to traditional platinum treatments are eligible to participate.

There will be an additional 30 sites in the USA, of which 7 are now recruiting patients, and there are 4 sites open in Australia.

The total number of patients to be treated in this pivotal study is 470. The trial consists of two double blind treatment arms. Patients in one trial arm will receive weekly carboplatin and phenoxodiol. Patients in the other trial arm will also receive weekly carboplatin, but a placebo will be substituted for phenoxodiol. Neither patients, nor their doctors will know to which trial arm the patients are randomised.

A change from receiving carboplatin (or cisplatin) in the traditional dose pattern (every two to three weeks) to a weekly carboplatin regimen has been reported to provide a tumour response in some patients with recurrent ovarian cancer(1-3). Thus in addition to learning more about the safety and efficacy of phenoxodiol, researchers will learn more about the efficacy 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 95 patients have progressed with their disease.

The trial is being run under arrangements approved by the US Food and Drug Administration (FDA) known as a Special Protocol Assessment (SPA). This provides for the interim analysis of the data, which, if significant, can be used to support a request for grant of marketing approval.

The Chief Executive Officer of Marshall Edwards, Inc., Mr. Christopher Naughton, said the Phase III Ovature study was a significant milestone for the Company.

"Over the next 12 to 18 months we expect the interim results from this multi-national clinical trial which ma
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SOURCE Novogen Limited
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