Message #1 From:
Jason Date: June 3, 2007 09:22:58 PM
NVGN, 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
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. (Nasdaq: MSHL) is 78.1 percent owned by the pharmaceutical company, Novogen Limited (Nasdaq: 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
