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The first patient to commence on the study at an Ovature site in the EUhas been enrolled at the Catholic University of Leuven, Belgium, under thedirection of Professor Ignace Vergote, Head of Gynaecologic Oncology.
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"We are hopeful that a positive outcome of this multi-centre study will bea significant medical advance for thousands of women with late stage ovariancancer whose tumors have become insensitive to the existing chemotherapeuticdrugs," Professor Vergote said.
"As one of Europe's largest cancer institutions, it is important for us tobe a part of these worldwide studies. It is important that we continue todevelop new ovarian cancer treatments. It is only through constant researchthat we will learn how to battle this deadly disease effectively," saidProfessor Vergote.
The Catholic University of Leuven is one of 26 sites in UK and Europewhich will be recruiting patients into this major multi-centre multinationalovarian cancer study to determine the safety and effectiveness of the drugphenoxodiol, when used in combination with the chemotherapy drug, carboplatin.Ovarian cancer patients whose cancer initially responded to chemotherapy, buthas since become resistant or refractory to traditional platinum treatmentsare eligible to participate.
There will be an additional 30 sites in the USA, of which 7 are nowrecruiting 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 trialarm will receive weekly carboplatin and phenoxodiol. Patients in the othertrial arm will also receive weekly carboplatin, but a placebo will besubstituted for phenoxodiol. Neither patients, nor their doctors will know towhich trial arm the patients are randomized.
A change from receiving carboplatin (or cisplatin) in the traditional dosepattern (every two to three weeks) to a weekly carboplatin regimen has beenreported to provide a tumor response in some patients with recurrent ovariancancer (1-3). Thus, in addition to learning more about the safety andefficacy of phenoxodiol, researchers will learn more about the efficacy ofweekly carboplatin.
The primary outcome of the trial is the assessment of the relative time ittakes for the ovarian cancer to progress. An analysis of interim results willbe possible after 95 patients have progressed with their disease.
The trial is being run under arrangements approved by the US Food and DrugAdministration (FDA) known as a Special Protocol Assessment (SPA). Thisprovides for the interim analysis of the data, which, if significant, can beused to support a request for grant of marketing approval.
The Chief Executive Officer of Marshall Edwards, Inc., Mr. ChristopherNaughton, said the Phase III Ovature study was a significant milestone for theCompany.
"Over the next 12 to 18 months we expect the interim results from thismulti-national clinical trial which may lead to the first approval forphenoxodiol," Mr. Naughton said.
In a prior Phase II clinical trial, phenoxodiol was tested in combinationwith either cisplatin or paclitaxel. Patients with late stage ovarian cancerthat had become refractory to platinum or paclitaxel therapy, followingmultiple courses of chemotherapy, were treated with phenoxodiol and cisplatinor phenoxodiol and paclitaxel, respectively. Of 21 patients in the cisplatinarm there were six partial responders, nine patients with stabilized diseaseand six patients who had disease progression; of 19 in the paclitaxel arm,there was one compl
