Interim results presented at the Annual Meeting of the American Association for Cancer Research in San Francisco demonstrate that a new experimental anti-cancer drug, phenoxodiol, produced minimal toxicity and stabilized cancer progression in a number of patients. Phenoxodiol is a synthetic compound that interrupts a newly identified function in cancer cells critical to the survival of cancer.

Researchers at The Cleveland Clinic Taussig Cancer Center are overseeing the only clinical trial in America of phenoxodiol, which was developed by the Australian-based drug discovery company Novogen Limited. The U.S. Food and Drug Administration in November 2001 allowed for the expedition of the trial based on data submitted from a similar trial being conducted in Australia.

Patients in the trial have a variety of cancers that have failed to respond to standard anti-cancer drugs. Phenoxodiol is administered by intravenous infusion for six weeks in the first instance. Treatment can be continued past six weeks if there is no evidence of tumor progression or serious toxicity. Six of 10 patients remained on phenoxodiol beyond six weeks following evidence of stabilization of the cancer.

"Phenoxodiol is an interesting new drug. It may target certain proteins in cancer cells that could be key to the cancer process," said Thomas Hutson, M.D., the trial's co-investigator.

"Phase I clinical trials are mainly about evaluating the safety of new drugs and how to use those drugs, rather than about whether the drugs work. We are encouraged that phenoxodiol was reasonably well tolerated," said Ronald Bukowski, M.D., also of The Cleveland Clinic.

The cancer types represented by patients in the trial include colon cancer, melanoma, thymic cancer, prostate cancer, RCC and TCC. Toxicity included moderate nausea, fatigue and shortness of breath.

SOURCES:
93rd Annual Meeting of the American Association for Cancer Research, April 8, 2002, San Francisco, CA
The Cleveland Clinic (http://www.clevelandclinic.org)