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RESULTS FROM PHENOXODIOL STUDY UPDATED

October 25, 2005

Researchers from Yale University's School of Medicine have reported updated results from studies they are conducting in women with late-stage ovarian cancer and in women with early-stage cancer of the cervix and vagina. These data, which focus on the investigational anticancer drug phenoxodiol (PXD), were presented recently at the 11th World Congress on the Menopause in Buenos Aires, Argentina.

The ovarian cancer study involved 43 patients whose cancer had failed to respond to all available therapies and were regarded as being resistant or refractory to the standard first-line therapies of a platinum (cisplatin or carboplatin) and/or a taxane (paclitaxel). A primary purpose of the study was to test the ability of PXD to reverse drug-resistance to cisplatin or paclitaxel, thereby restoring the ability of the cancers to respond to these potent anticancer drugs.

The key clinical endpoint of assessment of an investigational oncology drug is the impact on survival. The median survival in the PXD plus cisplatin arm was 62 weeks, and in the PXD plus paclitaxel arm, it was 48 weeks. At 75 weeks, 35 percent of patients in the PXD plus paclitaxel arm were still alive, and at 72 weeks, 35 percent of patients on the PXD plus cisplatin arm were still alive. This compares with median survival of only 28 to 40 weeks for patients on standard therapy. There were no PXD-related adverse events or side-effects reported in either study, indicating the high safety profile of the drug.