nrt - yale phenoxodiol study

NOVOGEN



ASX & M EDIA RELEASE 9 FEBRUARY 2004



STUDY AT YALE UNIVERSITY SUPPORTS DEVELOPM ENT OF PHENOXODIOL AS A DRUG TO RESTORE CHEMO-SENSIT1VITY IN NON-RESPONSIVE WOMEN WITH RECURRENT OVARIAN CANCER



Novogen Limited's subsidiary, Marshall Edwards, Inc. (LSE AIM: MSHand Nasdaq: MSHL) hasjust made the following announcement to the London Stock Exchange's Alternative Investment Market.


(San Diego, Calif. - February 9,2004) Researchers from Yale University School of Medicine reported preliminary results of a dose-finding study in women with recurrent ovarian cancer using phenoxodiol, an investigational anti-cancer drug being developed by Marshall Edwards, Inc. (Nasdaq: MSHL; LSEAIM: MSH). This early clinical testing supports the ability of phenoxodiol to act as both an anti-cancer agent in its own right and a chemo -sensitizing agent that restores responsiveness of ovarian cancer cells to standard chemotherapies. Phenoxodiol is an investigational drug and has not yet been approved for marketing in the U.S. The data were presented yesterday at the 35" Annual Meeting of the Society of Gynecologic Oncologists.



Phenoxodiol asMonotherapy



The data reflect outcomes from the first 20 of 40 measurable subjects at the first two doses tested in a dosing study to evaluate the effect of certain doses of phenoxodiol on disease progression and tumor response in women with recurrent disease that has become unresponsive to standard chemotherapy. According to the Yale researchers, of the 20 subjects who started the drug course, 13 were able to finish a three-month cycle, and five of the 20 subjects (25 percent) were considered to have had disease stabilization. All patients ultimately showed disease progression. However, no toxicity was attributed to phenoxodiol at the two dosing levels reported at thistime. Complete data from this study is not yet available according to the Yale researchers, and will be presented at a later date.



While pre-clinical studies of phenoxodiol have shown the ability to stop ovarian cancer growth in animals in its own right, the Yale researchers and the drug's developer, Marshall Edwards, Inc., are developing the drug in late-stage ovarian cancer as a chemo-sensitizer, restoring the sensitivity of the cancer cells to the cytotoxic action of standard chemotherapeutic drugs, in the expectation that that form of usage would deliver a greater anti-tumor effect in such advanced cases of cancer.



" Patients received phenoxodiol twice a week, which is how we believe it will be used in combinational therapy," said principal investigator Thomas Rutherford, M.D., Associate Professor of Gynecology and Reproductive Sciences. "We didn't expect to see a major anti-tumor effect when used at this dose, so it is encouraging to see an apparent 25 percent stability rate in such unresponsive cancers. These results give us confidence in the potential use of phenoxodiol for the treatment of ovarian cancer. We are highly encouraged by this outcome."



Phenoxodiol with Subsequent Chemotherapy



In an interim analysis of the entire study of 40 patients, where the Yale researchers focused on paclitaxel challenged patients, the researchers observed that eight of nine patientswho weretreated with paclitaxel

following completion of the phenoxodiol trial showed marked, declining levels of CA-125, a tumor marker for ovarian cancer. Four of these patients had previously been defined as paclitaxel resistant.



"Ttiisisapreliminaryfinding only, but onethat wefind highly encouraging because it supports in humanswhat we saw in the laboratory-- that phenoxodiol is a powerful chemo-sensitizer," said Gil Mor MD, PhD, Associate Professor and a co-investigator in the study. "Our experience is that few patients respond to follow-up therapy with taxanes once they have developed chemo-resistance, so to see this result is very encouraging."



Pre-clinical studies in cells and in animals showed that phenoxodiol was able to induce in chemo -resistant ovarian cancer cells susceptibility to being killed by extremely low doses of standard drugs such ascisplatin and paclitaxel.



Dr. Graham Kelly, Executive Chairman of Marshall Edwards, Inc., said, "We will be commencing a formal combinational study in ovarian cancer patients within the next couple of months. That will be the first time that we will have had the opportunity to use the drug the way that we believe it should be used. The current study has been useful in demonstrating the benefit of low doses of phenoxodiol, and we will be using the same low dose that has shown such promise in the current study."



According to the Ovarian Cancer National Alliance, ovarian cancer is the deadliest of the gynecologic cancers, and is the fifth leading cause of cancer death among U.S. women. Currently, 50 percent of the women diagnosed with ovarian cancer die from it within five years, largely because the cancer ultimately develops resistance to standard anti-cancer therapies.



Marshall Edwards, Inc., is developing phenoxodiol both as a monotherapy for the treatment of early-stage cancers (e.g. cervical, vaginal and prostatic adenocarcinomas) and as a chemo-sensitizer in combinational therapy for late-stage cancers (e.g. ovarian, prostate, renal, pancreatic carcinomas).



Marshall Edwards, Inc., manages its international research and development programs using the expertise and clinical research capabilities of universities and hospitals in the U.S., Australia and Europe.



Marshall Edwards, Inc., has licensed rightsto bring phenoxodiol to market globallyfrom its parent company, Novogen Limited. (Nasdaq: NVGN). Novogen is developing a range of therapeutics across the fields of oncology, cardiovascular disease and inflammatory diseases based on its phenolic drug technology platform.



More information on phenoxodiol and on the Novogen group of companies can be found at www.marshalledwardsinc.com and www.novogen.com.



ISSUED FOR : NOVOGEN LIMITED
LISTINGS : ASX (CODE NRT), NASDAQ (CODE NVGN).

FOR FURTHER
MR CHRISTOPHER NAUGHTON,
MANAGING DIRECTOR, NOVOGEN LIMITED
INFORMATION : TEL(02) 9878 0088http://www.novoaen.com

ISSUED BY :

WESTBROOKCOMMUNICATIONS
CONTACT: DAVID REID TEL (02) 9231 0922 OR 0417 217 157

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Fig Jam

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