OVArian TUmor REsponse ('OVATURE') Trial Enrolls First U.S. Patient

Phase III Trial for Phenoxodiol to Recruit Nearly 500 Patients with

Recurrent Ovarian Cancer at 60 Hospitals Worldwide

    DALLAS, June 1 /PRNewswire-FirstCall/ -- Researchers at the Harold C.
 Simmons Comprehensive Cancer Center at the University of Texas Southwestern
 Medical Center (UTSMC) have enrolled the first U.S. patient in the
 worldwide clinical trial looking at oral phenoxodiol in combination with
 carboplatin for the treatment of recurring ovarian cancer.
     Phenoxodiol has been shown in laboratory testing to be successful in
 restoring sensitivity of cancer cells from patients with ovarian cancer who
 have become resistant to standard chemotherapy drugs.
     At UTSMC, the OVATURE trial will be led by John Schorge, MD, Associate
 Professor of gynecologic oncology.
     "Earlier clinical studies have shown that phenoxodiol has an excellent
 safety profile, with few side effects, and that it appears to re-establish
 the sensitivity needed for chemotherapy drugs to work," said Dr. Schorge.
 "We're proud to be part of this trial because the advances in ovarian
 cancer are few and far between. We hope we can play a leadership role in
 finding ways to beat this deadly disease."
     This Phase III study will recruit 470 patients at approximately 30
 centers in the United States and 30 hospitals throughout Europe and
 Australia. Phenoxodiol, a capsule taken by mouth, is an investigational
 drug that has not yet been approved by the FDA. In the OVATURE trial,
 patients are randomly divided into two groups and receive either oral
 phenoxodiol in combination with carboplatin (a standard chemotherapy drug)
 or carboplatin with an inactive control capsule. Neither patient nor doctor
 will know which group each patient is in.
     All patients will receive carboplatin on a weekly basis, instead of
 receiving the customary carboplatin treatment of one intravenous infusion
 every three weeks, because some studies have shown that patients whose
 tumors have become resistant to the three-week standard regimen of
 carboplatin may respond to the weekly administration of the drug.
 Accordingly, researchers hope that patients on both arms of the trial may
 benefit.
     "This is the first of many prestigious U.S. institutions which will be
 participating in this trial," said Dr Patti Rossi, Vice President, Clinical
 Operations, Marshall Edwards, Inc. "Patients nationwide should have access
 to this trial, with as little disruption to their daily lives as possible.
 Accordingly, we're working with institutions across the U.S. which will be
 joining the trial shortly."
     About Chemo-Resistant Ovarian Cancer
     In many patients with ovarian cancer, cancer cells develop resistance
 to standard chemotherapy drugs, known as "chemoresistance," making it
 difficult to successfully manage and treat cancer.
     According to the Ovarian Cancer National Alliance:
     -- Ovarian cancer, the deadliest of the gynecologic cancers, is the fifth
        leading cause of cancer death among U.S. women. Ovarian cancer occurs
        in 1 out of 69 women;
     -- About 20,000 women are diagnosed with the disease each year;
     -- About 15,000 women in the United States die from ovarian cancer each
        year;
     -- Currently, 55 percent of the women diagnosed with ovarian cancer die
        from it within five years; among black women only 40 percent survive
        five years or more.*
     About Phenoxodiol
     Phenoxodiol has shown the ability to kill cancer cells that are
 relatively resistant to standard chemotherapy drugs in laboratory studies.
 The ability of phenoxodiol to overcome chemoresistance is thought to be due
 to its potential to disrupt various resistance mechanisms the cancer cell
 has developed.
     In 2004, phenoxodiol received fast track designation by the FDA for
 refractory ovarian cancer. Fast track allows for the expedited development
 of drugs that are intended to treat serious or life-threatening conditions
 and that demonstrate a potential to address unmet medical needs.
     About MEI
     Marshall Edwards Inc. is a leading biotechnology company in the
 development of cancer therapies. MEI is currently developing a range of
 anti- cancer therapies that represent the next generation of oncology
 drugs.
     Marshall Edwards Inc. ( MSHL) is 78.1 percent owned by the
 pharmaceutical company, Novogen Limited ( NVGN; ASX: NRT), from
 which it licenses phenoxodiol. More information on phenoxodiol and on the
 company can be found at www.marshalledwardsinc.com and www.novogen.com
     Under U.S. law, a new drug cannot be marketed until it has been
 investigated in clinical trials and approved by the FDA as being safe and
 effective for the intended use. Statements included in this press release
 that are not historical in nature are "forward-looking statements" within
 the meaning of the "safe harbor" provisions of the Private Securities
 Litigation Reform Act of 1995. You should be aware that our actual results
 could differ materially from those contained in the forward-looking
 statements, which are based on management's current expectations and are
 subject to a number of risks and uncertainties, including, but not limited
 to, our failure to successfully commercialize our product candidates; costs
 and delays in the development and/or FDA approval, or the failure to obtain
 such approval, of our product candidates; uncertainties in clinical trial
 results; our inability to maintain or enter into, and the risks resulting
 from our dependence upon, collaboration or contractual arrangements
 necessary for the development, manufacture, commercialization, marketing,
 sales and distribution of any products; competitive factors; our inability
 to protect our patents or proprietary rights and obtain necessary rights to
 third arty patents and intellectual property to operate our business; our
 inability to operate our business without infringing the patents and
 proprietary rights of others; general economic conditions; the failure of
 any products to gain market acceptance; our inability to obtain any
 additional required financing; technological changes; government
 regulation; changes in industry practice; and one-time events. We do not
 intend to update any of these factors or to publicly announce the results
 of any revisions to these forward-looking statements.
     * Sources: U.S. Cancer Statistics Working Group. United States Cancer
 Statistics: 2003 Incidence and Mortality Web-based Report. Atlanta: U.S.
 Department of Health and Human Services, Centers for Disease Control and
 Prevention and National Cancer Institute; 2006. Available at:
 htttp://www.cdc.gov/cancer/npcr/uscs.
     Ries LAG, Harkins D, Krapcho M, Mariotto A, Miller BA, Feuer EJ, Clegg
 L, Eisner MP, Horner MJ, Howlader N, Hayat M, Hankey BF, Edwards BK (eds).
 SEER Cancer Statistics Review, 1975-2003, National Cancer Institute.
 Bethesda, MD. Available at: http://seer.cancer.gov/csr/1975_2003/. Based on
 November 2005 SEER data submission, posted to the SEER web site 2006.
 
 

SOURCE Marshall Edwards Inc.