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February 20, 2004|Volume 32, Number 19



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Researchers report promising results
in study of experimental drug used
to treat ovarian cancer

Yale researchers have reported promising preliminary results from a study of an experimental drug being used to treat women with recurrent ovarian cancer.

The Phase Ib/IIa study is examining the effectiveness of phenoxodiol, an anti-cancer drug that could kill cancer cells and increase effectiveness of standard chemotherapy. The main purpose of the study was to determine the dose of phenoxodiol to be used in combination with other anti-cancer drugs. The researchers found no toxicity, 25% response and synergy with chemotherapy.

The data were presented by Dr. David O'Malley, instructor in the Department of Obstetrics, Gynecology & Reproductive Sciences, at the 35th Annual Meeting of the Society of Gynecologic Oncologists in San Diego, California, on February 8.

While phenoxodiol has the ability to stop ovarian cancer growth in animals in its own right, Marshall Edwards Inc., the company that originally created the drug, and Yale researchers are developing the drug in late-stage ovarian cancer as a chemo-sensitizer, restoring the sensitivity of the cancer cells to standard chemotherapeutic drugs.

"Patients received phenoxodiol twice a week, which is how we believe it will be used in combinational therapy," says principal investigator Dr. Thomas Rutherford, associate professor of gynecology in the Department of Obstetrics, Gynecology & Reproductive Sciences. "We didn't expect to see a major anti-tumor effect when used at this dose, so it is encouraging to see an apparent 25% stability rate in such unresponsive cancers. These results gave us confidence in the potential use of phenoxodiol for the treatment of ovarian cancer. We are highly encouraged by the outcome."

The data reflected outcomes from the first 20 of 40 patients enrolled in the study with late-stage ovarian cancer that had become unresponsive to standard chemotherapy. Of the 20 patients who started the course of treatment, 13 were able to finish a three-month program without disease progression. Five of these patients were evaluated to have disease stabilization; all of these patients later experienced progression of the disease.

In a follow-up of the study, eight of nine patients who were treated with paclitaxel-standard chemotherapy after completion of the phenoxodiol trial showed a positive serologic response to paclitaxel therapy. Four of these patients had previously been defined as resistant to paclitaxel.

"This is a preliminary observation only, but one that we find highly encouraging because it confirms in humans what we saw in the laboratory -- that phenoxodiol is a powerful chemo-sensitizer," says Dr. Gil Mor, associate professor and a co-investigator in the study.

-- By Karen Peart


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