'Cautious Optimism' Expressed For New Anti-Cancer Drug; Novogen's Phenoxodiol Stabilizes Cancer Progression with Minimal Toxicity.

Business Editors/Health & Medical Writers

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SAN FRANCISCO--(BUSINESS WIRE)--April 8, 2002

Preliminary clinical trial results of the novel anti-cancer drug phenoxodiol indicate that it slowed cancer progression in six out of 10 patients at doses that were well tolerated.

The interim trial results were presented here today at the 93rd annual meeting of the American Association for Cancer Research (AACR), by researchers from the Cleveland Clinic's Taussig Cancer Center.

Phenoxodiol represents a new direction for anti-cancer therapy. The drug targets the underlying control mechanism in cells that determines whether a cell will survive or die. This mechanism malfunctions in cancer cells, often preventing them from dying or being killed by drugs.

Phenoxodiol targets the activities of key members of this control mechanism including sphingosine kinase and the caspase proteins.

Phenoxodiol was discovered by Australian pharmaceutical company, Novogen Limited (Nasdaq:NVGN) and is being developed by its U.S. subsidiary Marshall Edwards, Inc.

"We are very encouraged by this early result," said Graham Kelly Ph.D., Chairman of Marshall Edwards, Inc. "The data presented today is consistent with what we've seen in other trials with phenoxodiol which is stabilization of cancer growth in some patients without serious toxicity."

"We continue to refine the search for the optimum dose, the best method of administration, and the cancer targets that will respond best to phenoxodiol," said Dr. Kelly. "But we are exactly where we expected to be today."

Patients on the trial have a variety of cancers that have failed to respond to standard anti-cancer drugs. In the Cleveland trial, 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 or not the drug works. We are encouraged that phenoxodiol was reasonably well tolerated," said Ronald Bukowski, M.D., Director of Experimental Therapeutics at the Cleveland Clinic Taussig Cancer Center.

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

Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials. After the results of these trials are submitted in a new drug application to the FDA, the FDA must approve the drug as safe and effective before marketing can take place.

Novogen is a pharmaceutical company based in Sydney, Australia with offices in Stamford, Connecticut. More information on phenoxodiol can be found at www.novogen.com and www.marshalledwardsinc.com.

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