Novogen Limited's subsidiary, Marshall Edwards Inc has plans to commence a Phase II clinical trial at Yale University School of Medicine of its novel anti-cancer drug, phenoxodiol, in women with recurrent ovarian and fallopian cancers.

Phenoxodiol will be assessed for its ability to halt the growth or to shrink tumors in women with ovarian or fallopian cancer who have failed other forms of chemotherapy. Phenoxodiol will be the only anti-cancer drug to be used in these women. The trial is part of a multi-centre, multi-national study. Yale University is the only US site participating in this trial.

The trial will be led by Thomas Rutherford, Associate Professor of Gynecologic Oncology and Dr Gil Mor, Associate Professor of Obstetrics and Gynecology. A total of approximately 40 women who have already failed other forms of chemotherapy will be enrolled in the trial in the first instance.

Patients will receive phenoxodiol by intravenous injection on two consecutive days per week for a treatment cycle lasting 12 weeks. The clinical end-points will include tumor mass, tumor markers, and one-year survival.

"We have had particularly exciting results with phenoxodiol in the laboratory, finding that phenoxodiol was able to induce cell death in ovarian cancer cells that proved to be resistant to the effects of all other drugs, including those presently in use for the treatment of ovarian cancer," Dr Mor said.

"We have good evidence as to why this is happening, and we look forward to seeing the drug tested in women with this difficult form of cancer."

Dr Rutherford said that in the Yale laboratories, they could not find another compound as promising as phenoxodiol for this form of cancer.

Executive Chairman of Marshall Edwards Inc, Dr Graham Kelly, said the significance of this Phase II trial was that phenoxodiol was the first drug in Phase II trials that switched off production within cancer cells of the main anti-apoptotic proteins, FLIP and XIAP.

"These proteins have been identified recently as being critically important to the ongoing survival of many forms of human cancer, including ovarian cancer," Dr Kelly said.

"The targeting of these proteins by drug therapy has become a major focus of oncologists."