Clinical Trial Data Released at ASCO Supports Safety Profile for Marshall Edwards Inc.'s Experimental Anti-Cancer Drug Phenoxodiol.Business Editors/Health & Medical Writers BIOWIRE2K STAMFORD, Conn.--(BW HealthWire)--May 22, 2002 A second round of data from a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I of phenoxodiol confirm previous findings and have been included in the proceedings of the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. , which met in Orlando, Florida The city of Orlando is a major city in central Florida and is the county seat of Orange County, Florida. According to the 2000 census, the city population was 185,951. A 2006 U.S. this week. Initial data from this trial were presented at the AACR-NCI-EORTC International Conference in Miami, October 2001. The study reports on eighteen patients who received phenoxodiol at St. George Hospital in Sydney, Australia. All patients had rapidly growing, terminal cancer and received one injection of phenoxodiol each week for six weeks. The study was conducted principally to determine the safety of the drug, and the outcome was that the drug had none of the side-effects normally associated with chemotherapy. A secondary outcome was to gain some preliminary evidence of those tumors that might respond to phenoxodiol. This was measured on the basis of patients showing no evidence of disease progression after six weeks. The results were that seven of the 18 patients continued treatment for at least 12 weeks, with two continuing treatment for periods up to 24 weeks with evidence of stabilization of their tumors. Given the advanced state of these tumors and the fact that they had become resistant to all other forms of chemotherapy, company officials view these results as highly encouraging. Phenoxodiol, which is being developed by Marshall Edwards Marshall Lynn Edwards (August 27, 1952 in Fort Lewis, Washington), is a former professional baseball player who played outfielder in the Major Leagues from 1981-1983. He would play for the Milwaukee Brewers. Inc. (MEI), is expected to enter into Phase II clinical trials in Australia and the U.S. later this year. These trials will further assess its clinical effectiveness in determined cancer targets. 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , the FDA must approve the drug as safe and effective before marketing can take place. MEI, which begins trading today on the U.K.'s AIM stock exchange, is 90 percent owned by Novogen Limited (Nasdaq: NVGN). 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, that Novogen has licensed into the company. Novogen is a pharmaceutical company based in Sydney, Australia with offices in Stamford, Connecticut Stamford is a city in Fairfield County, Connecticut, United States. According to 2006 Census Bureau estimates, the population of the city is 119,261, making it the fourth largest city in the state. . Novogen Limited is listed on the ASX ASX See: Australian Stock Exchange as "NRT NRT Nicotine Replacement Therapy NRT Norm-Referenced Test NRT near real time NRT Non-Real-Time NRT National Response Team NRT Tokyo, Japan - Narita (Airport Code) NRT Net Registered Tonnage " and in the U.S. on the NASDAQ as "NVGN". Marshall Edwards Inc. is listed on AIM as "MSH MSH melanocyte-stimulating hormone. MSH abbr. melanocyte-stimulating hormone MSH, n See hormone, melanocyte-stimulating. MSH melanocyte-stimulating hormone. ". More information on phenoxodiol can be found at www.novogen.com and www.marshalledwardsinc.com. 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 commercialisation, 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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