mei announces cervical cancer trial, page-2

ASX & MEDIA RELEASE
22 FEBRUARY 2004
MARSHALL EDWARDS, INC., COMMENCES CLINICAL TRIAL IN CERVICAL CANCER AT YALE

Novogen Limited’s subsidiary, Marshall Edwards, Inc. (LSE AIM: MSH and Nasdaq: MSHL) has just made the following announcement to the London Stock Exchange’s Alternative Investment Market.
(Washington DC – February 22, 2004)

Marshall Edwards, Inc. (NASDAQ : MSHL; LSE-AIM : MSH) has commenced a new human clinical trial of the investigational anti-cancer drug, phenoxodiol, in patients with cancer of the cervix.

The study of patients with squamous cell carcinoma and adenocarcinoma of the cervix vagina and vulva is being conducted at Yale-New Haven Hospital, Connecticut, USA.

The Principal Investigator is Dr Masoud Azodi of the Yale University School of Medicine.
The subjects in the study will have a primary diagnosis of cancer and after four weeks of daily phenoxodiol treatment in its oral dosage form will be scheduled for either surgical resection or radiotherapy.

This design is known as a neo-adjuvant study.
The study will evaluate the safety and ability of phenoxodiol to act as an effective anti-cancer agent when it is given as a monotherapy in early-stage cancer.

Because this is the first study in the U.S. using phenoxodiol in its oral dosage form, it is to be termed a Phase I trial. Phenoxodiol was used in the intravenous dosage form, also at Yale, in the now completed Phase II trial for chemo-resistant ovarian cancer.

Marshall Edwards, Inc., is pursuing a dual strategy of developing phenoxodiol for the treatment of both early stage cancers and late-stage cancers.

The strategy in early-stage cancers of using phenoxodiol as a monotherapy is intended to result in the killing of cancer cells before they have had a chance to develop the prosurvival techniques that characterize many late-stage cancers.

The strategy being employed for late-stage cancers is to use phenoxodiol as a chemo -sensitizing agent in combination with standard drugs.

Pre-clinical studies have shown that phenoxodiol potently synergizes the action of standard anti-cancer drugs such as platinums, taxanes, gemcitabine and camptothecin, as well as restoring sensitivity in chemo-resistant cancer cells.

One of the main ways in which phenoxodiol functions, is to inhibit the production within the cancer cell of antiapoptotic or pro-survival proteins such as FLIP and XIAP.

These are proteins produced by all cells as a way of blocking the action of death receptors and inhibiting apoptosis. Proteins such as XIAP are over-expressed in many cancers as well as being associated with the development of resistance to anti-cancer drugs.

By inhibiting the production of these blocking proteins, phenoxodiol restores the ability of the cancer cell to undergo apoptosis, as well as restoring the ability of cancer cells to respond to the killing effects of many standard anticancer drugs.

Dr. Graham Kelly, Executive Chairman of Marshall Edwards, Inc., said, “by comparing the size and appearance of the tumor at both the start and conclusion of the study, researchers have the chance to document the anticancer
effect of phenoxodiol in a precise way.

“Cervical cancer is a squamous cell carcinoma, which is the main form of cancer found in tumors of the head, neck, mouth, esophagus, cervix, vagina and bladder,” Dr. Kelly said.

The study will involve 20 women. Phenoxodiol will be given as an oral capsule, three times per day, using two different dosages in order to determine the dose-response effect.
Phenoxodiol was developed by Novogen Limited

(Nasdaq: NVGN; ASX: NRT) and licensed to Marshall Edwards, Inc.. It is an investigational anti -cancer drug that has yet to receive marketing approval by regulatory
authorities.

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 rights to bring phenoxodiol to market globally from 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 0088 http://www.novogen.com
ISSUED BY : WESTBROOK COMMUNICATIONS
CONTACT: DAVID REID TEL (02) 9231 0922 OR 0417 217 157