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$21m RAISED FOR PHENOXODIOL CLINICAL STUDIES
NOVOGEN RAISES $21 MILLION TO FUND PHENOXODIOL CLINICAL STUDIES
Novogen Limited has arranged A$21.6 million from international institutional investors through the issue of 10.55 million ordinary shares in the Company.
The share price had been struck at A$2.05, which was the closing offer price of Novogen shares on the ASX on the initiating date, Wednesday 23 May 2001.
Directors said the capital raising would be used to fund ongoing clinical trials of Novogens novel anti-cancer drug, phenoxodiol, ongoing development of Novogens additional drug compounds, and for general corporate purposes.
A key component of the capital raising is the opportunity currently available to Novogen to accelerate the development of phenoxodiol through an expanded clinical trials program, based on early promising clinical results.
Phenoxodiol introduces a new class of anti-cancer drugs that target enzyme systems common to all cells but which are only inactivated by the drug in cancer cells. The result is that phenoxodiol kills a wide range of human cancer cells while not harming healthy cells.
The early clinical experience with phenoxodiol led to it being granted Investigational New Drug (IND) status by the US Food and Drug Administration (FDA), on 29 January 2001. That status has led to commencement of the clinical trial of phenoxodiol at the Cleveland Clinic Taussig Cancer Centre, in Cleveland, Ohio, one of North Americas largest cancer clinics.
The Company plans to fund the development of phenoxodiol through the listing of a new subsidiary company Marshall Edwards Incorporated (MEI).
However, delays in approval of the prospectus for the initial public offer lodged on 27 April, 2001, have prompted Directors to guarantee continuation of the momentum of the clinical study program through an alternative funding mechanism.
The Board was of the view that an initial listing of MEI in Australia would facilitate involvement of Australian residents in this opportunity which has global potential. However due to the protracted regulatory delays, the Companies are now considering bringing forward alternate offshore funding strategies for MEI.
Another anti-cancer drug, Gleevec*, designed to treat two rare forms of cancer, recently was given fast track approval by the US FDA. Gleevec, like phenoxodiol, is selectively toxic to cancer cells.
Directors said the enthusiasm of US and European institutional investors about phenoxodiol was because of phenoxodiols novelty, its broad applicability to common human cancers, and evidence of the FDAs preparedness to consider fast-track approval of drugs showing such selective toxicity.
The US clinical trial is being conducted by Doctor Ronald Bukowski, the head of experimental therapeutics at the Cleveland Clinic Taussig Cancer Centre, and is focussing on people with late-stage metastatic cancer.
The US trial builds on Phase 1b/2a human trials already underway in Australia.
Dr Bukowski has told the US media that he was interested in the whole class of drugs such as phenxodiol and that it could be a new direction in cancer treatment.
"The Australian trials in patients with advanced metastatic cancer have provided encouraging results," Dr Bukowski said.
"These trials were intended to determine the drug's toxicity. To date, no toxicity has been found.
These trials were also designed to explore the drug's anti-tumour activity and the range of tumours likely to be sensitive to phenoxodiol."
Dr. Bukowski said the drug could be used for slow-growing cancers that required extended therapy.
Based in Sydney, Novogen is a world leader in the field of phenolic drug research and development.
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 Companys 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 commercialisation, if any, of the Companys proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks).
[*Gleevec is a registered trademark of Novartis Pharmaceuticals Corporation.]
ISSUED FOR : NOVOGEN LIMITED
LISTINGS : ASX (CODE NRT) NASDAQ (CODE NVGN).
FOR FURTHER INFORMATION : MR CHRISTOPHER NAUGHTON, MANAGING DIRECTOR, NOVOGEN LIMITED TEL (02) 9878 0088 http://www.novogen.com
ISSUED BY : WESTBROOK COMMUNICATIONS CONTACT: DAVID REID TEL (02) 9231 0922 OR 0417 217 157
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