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Tuesday, 24 September 2002

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phenoxodiol enters phase II clinical trial in patients with leukemia
Anti –cancer pharmaceutical company Marshall Edwards Inc today announced that its lead anti-cancer compound phenoxodiol is entering a Phase II human clinical trial in patients with leukemia at the Royal North Shore Hospital, Sydney.

The trial protocol calls for phenoxodiol to be administered intravenously. The new trial supplements the earlier Phase I study of the oral dosage form of phenoxodiol in patients with leukemia at the same hospital.

Phenoxodiol has completed one Phase I clinical study by intravenous form, and is near to completion of two others, in the US and in Australia. Those studies revealed that phenoxodiol was well tolerated and provided an anti-tumor effect in a number of patients. The Phase I program was conducted in patients with a wide range of cancer types.

Phase II clinical trials will involve using phenoxodiol in patients with selected tumor types. The selected tumor types include leukaemias, ovarian carcinoma, renal carcinoma and prostate carcinoma.

These forms of cancer are known to be associated with a defect of their death receptor mechanisms. This defect allows the cancer cells to escape attack by the body’s defense systems. Phenoxodiol has been shown to specifically target these mechanisms, inhibiting the ability of the cancer cell to make the anti-apoptotic proteins, c-FLIP and XIAP. Marshall Edwards Inc Chairman, Dr Graham Kelly, said the trial was important for two reasons. “First because it is the milestone of phenoxodiol entering into Phase II human trials and second, because this is the first time a drug will be tested in cancer patients against a group of proteins that is now thought to be fundamental to the survival of cancer cells”.

MEI (LSE-AIM: MSH), is 95 percent owned by Novogen Limited. MEI was established to provide a commercial vehicle for Novogen's anti-cancer drug technology, the first of which is the novel anti-cancer drug phenoxodiol. Novogen (Nasdaq: NVGN) is a pharmaceutical company based in Sydney, Australia with offices in Stamford, Connecticut. More information on phenoxodiol can be found at http://www.novogen.com and http://www.marshalledwardsinc.com. 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.

Statements herein that are not descriptions of historical facts are forward-looking and subject to risk and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in the Company's Securities and Exchange Commission filings under "Risk Factors," including risks relating to the early stage of products under development; uncertainties relating to clinical trials; dependence on third parties; future capital needs; and risks relating to the commercialization, if any, of the Company's proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks).


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