Marshall Edwards, Sanofi-Aventis plan trial of phenoxodiol with docetaxel for ovarian cancer

New York, Nov. 28 - Marshall Edwards, Inc. said it and Sanofi-Aventis are planning a phase 1b/2a clinical study of the investigational anti-cancer drug phenoxodiol in combination with docetaxel for women with recurrent ovarian cancer.

The investigator-initiated study will take place at the Yale University School of Medicine.

"Advanced-stage ovarian cancer is one of the most devastating forms of cancer, with half of the women diagnosed with it dying within five years," said Thomas Rutherford, the study's principal investigator. "One of the imperatives facing doctors who treat these patients is to find ways to restore sensitivity to drugs such as taxanes once they start to lose that sensitivity.

"The highly encouraging pre-clinical and clinical data that we have seen with phenoxodiol when it has been used as a chemo-sensitizer to date, gives us optimism that this strategy will provide the means to improve the survival of these late-stage cancer patients."

Docetaxel is a second-generation taxane that is commonly used in patients with recurrent or persistent ovarian cancer that have failed other therapies, including the first-generation taxane, paclitaxel.

The study is intended to find out whether the addition of phenoxodiol to docetaxel can improve clinical response and survival by delaying or preventing the development of chemo-resistance in women with recurrent ovarian cancer.

Prompting the research are pre-clinical studies which show the ability of phenoxodiol to reverse chemo-resistance to docetaxel in human ovarian cancer cells through the ablation of anti-apoptotic proteins in the tumor cells. In addition, an "encouragingly" high tumor response rate has been observed in a current clinical study where phenoxodiol is being used to chemo-sensitize paclitaxel in advanced-stage ovarian cancer patients where the tumor is taxane-resistant or refractory.

Marshall Edwards is North Ryde, New South Wales, Australia, subsidiary of Novogen Ltd. working on anti-cancer therapies.

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