Novogen reports phenoxodiol shown to impede prostate cancer

By Ted A. Knutson

Washington, Nov. 17 - Novogen Ltd. said a new study presented Thursday at the International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia shows that phenoxodiol significantly delays tumor progression in men suffering from late-stage hormone refractory prostate cancer.

The meeting is sponsored by the American Association of Cancer Researchers, the National Cancer Institute and the European Organization for Research and Treatment of Cancer.

"Phenoxodiol represents a unique new class of drugs for men with prostate cancer," said Dr. Steven Tucker, director of Prostate and Genitourinary Oncology at The Angeles Clinic & Research Institute in Los Angeles, in a Novogen news release. "If the clinical benefit seen in these refractory patients can be extended into an earlier disease state, we may be looking at a paradigm shift in the management of advanced prostate cancer."

The anti-tumor effect in this phase Ib/IIa trial was dose-dependent. The trial was designed to end after 24 weeks of treatment but had to be extended to the current 90 weeks because of the unexpected extended survival in some patients.

Patients have been able to remain on phenoxodiol for this extended time without any evidence of toxicity.

Researchers administered various doses (20, 80, 200 and 400 mg) of phenoxodiol to men with metastatic, hormone-refractory prostate cancer to establish what level of anti-cancer effect the oral dosage form of this drug would provide and whether there was a dose-dependent effect.

The phenoxodiol was administered in monthly treatment cycles comprised of three doses daily for 21 consecutive days followed by seven days without treatment. The original plan was to treat patients for a maximum of six treatment cycles. Except for anti-androgen therapy being continued in those who were receiving it pre-trial, phenoxodiol was the only treatment.

The age of the 26 subjects studied ranged from 55 to 85, the Gleason score was mean 8.04 (range 6-9), and the mean baseline PSA level was 56.3 pg/ml.

"The two highest dosages of phenoxodiol provided a significant anti-tumor response in a disease that is normally unresponsive to treatment in its late stages," says Dr. Robert Davies, lead investigator of the study and urologist at Sir Charles Gairdner Hospital in Perth, Australia, in the news release. "We found that the PSA level, an indicator of the level of cancer, decreased. We also saw a clinical response that was prolonged in some patients."

Combining the data from the two lowest dosages (12 patients) and the two highest dosages (14 patients), the number of patients still on therapy after six months increased from 1 out of 12 (8.5%) to 10 out of 14 (71.4%), and the mean time to progression (length of time patients were deemed to be deriving a benefit from therapy) increased from 15 weeks to 47 weeks. This latter figure does not take into account four patients who remain on therapy after 42, 74, 82 and 90 weeks.

"The long-term anti-tumor effects and safety demonstrated in this study are very encouraging developments," said Graham Kelly, chairman of Marshall Edwards, Inc., in a Novogen news release.

Marshall Edwards has licensed rights to bring phenoxodiol to market globally from its parent company, Novogen, a North Ryde, Australia-based biotech company.

The announcement was made in a Novogen 6-K filing with the Securities and Exchange Commission.

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