Trial Results Positive in Late-Stage Refractory Ovarian Cancer Patients

May 10, 2005

Marshall Edwards has released preliminary results from a Phase IIa trial in patients with ovarian cancer that has demonstrated resistance to the standard first-line chemotherapies of cisplatin and/or paclitaxel.

In this trial, the investigational drug phenoxodiol is being administered in conjunction with cisplatin or paclitaxel in an attempt to reverse the acquired resistance of the tumors to those two drugs.

The multicenter trial is being conducted at the Yale -- New Haven Hospital, New Haven, Conn., and at the Royal Women's Hospital, Melbourne, Australia. Enrollment in the current trial was limited to patients who demonstrated a high level of chemo-resistance to either platinums (cisplatin or carboplatin) or taxanes (paclitaxel, docetaxel). Patients were either refractory, which is defined as disease progression while on chemotherapy, or resistant, which is defined as having disease progression within six months of receiving such chemotherapy. In addition, patients were enrolled within an average seven months of completion of the last course of treatment with platinums or taxanes, when chemo-resistance remains high.

Twenty subjects received a combination of phenoxodiol plus cisplatin, and 20 patients received phenoxodiol plus paclitaxel. Roughly 80 percent of subjects on combination therapy had either complete response (11 percent), partial response (22 percent) or stabilized disease (44 percent), providing an overall disease control rate of 77 percent. The phenoxodiol and cisplatin or paclitaxel combinations were well-tolerated, with no unexpected toxicities encountered.