Progen's Anti-cancer Drug Trial Receives Second Site Approval From Peter MacCallum Cancer Institute, Subject to Final Administrative Filings.
BRISBANE, Australia--(BW HealthWire)--Aug. 26, 1999--
Progen Industries Limited (ASX ASX
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U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :PGLAF PGLAF Project Gutenberg Literary Archive Foundation ), today received provisional approval from the Peter MacCallum Cancer Institute's Ethics Committee ethics committee A multidisciplinary hospital body composed of a broad spectrum of personnel–eg, physicians, nurses, social workers, priests, and others, which addresses the moral and ethical issues within the hospital. See DNR, Institutional review board. to commence testing its anti-cancer drug, PI-88, at the Institute under the umbrella of Centre for Developmental Cancer Therapeutics.
Progen Industries Limited Managing Director Mr Alan Scott said this was the second CDCT location in Melbourne at which the biotechnology company had received approval to hold the trial.
"In June this year, we received provisional approval from the Royal Melbourne Hospital's Ethics Committee to trial PI-88 at the Hospital under the CDCT," he said.
He said the trial would take place in Melbourne between the two locations and would involve approximately 40 patients whose tumours no longer responded to standard therapies."
He said the CDCT was an important partner in the development of PI-88.
The CDCT is a consortium involving four major Melbourne hospitals and two internationally renowned oncology research centres. This network offers the facilities and expertise for conducting Phase I and Phase II clinical trials.
A CDCT spokesperson said the organisation was working closely with Progen to get the trial up and running and, subject to further administrative procedures, it was confident they could begin in the near future. Progen therefore, subject to this factor, is planning for the trial to start in September.
If this trial is successful, Progen will move PI-88 to a Phase II trial which involves testing a fixed dose of the drug on an increased number of cancer patients to assess its efficacy.
Mr Scott said PI-88 had the potential to treat a wide range of cancers including breast, lung, prostate and colon cancer colon cancer, cancer of any part of the colon (often called the large intestine). Colon cancer is the second most common cancer diagnosed in the United States. .
"The incidence of cancer throughout the world is growing at an accelerated rate with Australia alone experiencing an increase of eight percent for men and 11 percent for women between 1985 and 1995," he said.
"Current data suggests that between one in three to four Australians will suffer from cancer during their lifetime."(a)
Mr Scott said the world cancer therapeutic market was estimated to be currently worth A$20 billion.(b)
Progen is expected to announce its full year results shortly. As at August 25, 1999, Progen's market capitalisation totalled A$87 million.
Note (a): Australian Institute of Health and Welfare
Note (b): Frost and Sullivan market Intelligence, 1993
This press release contains forward-looking statements that are based on current management expectations. These statements may differ materially from actual future events or results as a result of certain risks and uncertainties, including but not limited to, risks associated with the development and manufacture of PI-88 and inherent in the extensive regulatory approval process mandated by the Australian Therapeutic Goods Administration The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia. and the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. , delays in the conduct of clinical trials, in obtaining the necessary approvals for additional clinical testing and for marketing of PI-88, market acceptance of the compound, general economic conditions, and other risks and uncertainties detailed from time to time in Progen's filings with the Australian Stock Exchange Australian Stock Exchange (ASX)
Australia's major securities market, formed when the six state stock exchanges (Adelaide, Brisbane, Hobart, Melbourne, Perth, and Sydney stock exchanges) were merged in 1987. and the United States Securities and Exchange Commission.