New Canaan, Conn., Sept 5, 2007 — A new website has been launched to facilitate recruitment of patients to OVATURE (OVArian TUmor REsponse), a Phase III clinical trial of an investigational ovarian cancer drug phenoxodiol. The goal of www.OVATUREtrial.com is to inform ovarian cancer patients about the OVATURE trial, which is actively recruiting patients, and to provide more information about the trial and the investigational drug phenoxodiol. Visitors to the site will find information about the trial including eligibility, trial locations and participating doctors.
Hospitals and treatment centers throughout the United States, Europe and Australia are serving as trial sites, and www.OVATUREtrial.com will guide patients to site locations as they begin recruiting. Ovarian cancer patients whose cancer initially responded to chemotherapy, but has since become resistant or refractory to traditional platinum treatments are eligible to participate.
In the U.S. 30 sites are planned and the current trial locations include Yale University School of Medicine in New Haven, Connecticut; the Women’s Cancer Center of Nevada in Las Vegas, Nevada; the University of Texas Southwestern Medical Center at Dallas in Dallas, Texas; Providence Hospital and Medical Centers in Southfield, Michigan; Hematology Oncology in Stamford, Connecticut; Gabrail Cancer Center in Canton, Ohio; Northern Virginia Pelvic Surgery Associates in Annandale, Virginia; and Chattanooga GYN Oncology in Chattanooga, Tennessee.
In Australia, the current trial locations include Prince of Wales Hospital and Westmead Hospital in Sydney; Royal Adelaide Hospital, in Adelaide; and Mater Adult Hospital in Brisbane. In Europe, 26 sites are planned and recruitment has commenced at UZ Leuven Gynaecological Oncology in Leuven, Belgium.
The trial is studying the safety and effectiveness of the drug phenoxodiol, which has not yet been approved for marketing by the FDA, when used in combination with weekly doses of the chemotherapy drug, carboplatin. The trial will consist of two double blind treatment arms. Patients in one trial arm will receive weekly carboplatin and phenoxodiol. Patients in the other trial arm will also receive weekly carboplatin, but a placebo will be substituted for phenoxodiol. Neither patients, nor their doctors will know to which trial arm the patients are randomized.
A change from receiving carboplatin (or cisplatin) every two to three weeks to a weekly carboplatin regimen has been reported to provide a tumor response in some patients with recurrent ovarian cancer. In addition to learning more about the safety and efficacy of phenoxodiol, researchers will learn more about the efficacy of weekly carboplatin.
In laboratory studies using animal models of cancer and human cell lines, phenoxodiol was shown to reverse chemoresistance to standard chemotherapies, including platinum drugs, taxanes, gemcitabine, topotecan and doxorubicin. The ability of phenoxodiol to reverse multi-drug resistance is thought to be due to its disruption of several key targets specific to tumor cell biochemistry.
In a prior Phase II clinical trial, phenoxodiol was tested in combination with either cisplatin or paclitaxel. Twenty one patients with late stage ovarian cancer that had become refractory to platinum (cisplatin or carboplatin) and 19 patients that had become resistant to paclitaxel therapy, following multiple courses of chemotherapy, were treated with phenoxodiol and cisplatin or phenoxodiol and paclitaxel, respectively. The cisplatin (40 mg/m2) or paclitaxel (80 mg/m2) was administered weekly, and phenoxodiol was administered by intravenous infusion at 3 mg/kg on two consecutive days immediately prior to the cisplatin administration. Treatment was for six weeks and was continued until dose limiting toxicity or disease progression.
In this trial, as measured using the RECIST criteria, in the cisplatin arm there were six partial responders, nine patients with stabilized disease and six patients who had disease progression; in the paclitaxel arm, there was one complete responder, two partial responders, eleven with stabilized disease and five patients who had disease progression. For more information about RECIST, visit www.recist.com. There were few side effects associated with phenoxodiol, but, as with any investigational drug, there is a possibility of unexpected side effects.
Women who are interested in participating in the OVATURE trial, or who simply wish to learn more about this study should visit www.OVATUREtrial.com.
About Phenoxodiol Phenoxodiol is believed to help chemotherapy drugs, such as carboplatin, kill chemoresistant cancer cells by removing factors in the cells that block the killing action of chemotherapy.
Phenoxodiol appears to selectively inhibit the pro-survival regulator in cancer cells known as S-1-P (sphingosine-1-phosphate) that is over expressed in cancer. In response to phenoxodiol, the S-1-P content in cancer cells is decreased rendering those cells more sensitive to chemotherapy. Indeed, in laboratory studies, it has been demonstrated that cancer cells pre-treated with phenoxodiol were killed with lower doses of chemotherapy drugs. Importantly, phenoxodiol has been shown not to adversely affect normal cells in animal and laboratory testing.
Importantly, phenoxodiol has been shown not to adversely affect normal cells in animal and laboratory testing.
Phenoxodiol is being investigated as a therapy for late-stage, chemoresistant ovarian, prostate and cervical cancers. Phenoxodiol has received Fast Track status from the FDA to facilitate development as a therapy for recurrent ovarian and prostrate cancers.
Phenoxodiol is an investigational drug and, as such, is not commercially available. Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by FDA as being safe and effective for the intended use.
About Marshall Edwards Inc: Marshall Edwards, Inc. (Nasdaq: MSHL) is a specialist oncology company focused on the clinical development of novel anti-cancer therapeutics. These derive from a flavonoid technology platform which has generated a number of novel compounds characterized by broad ranging efficacy against a range of cancer targets with few side effects. The unique combination of efficacy and safety has been explained by their ability to target an enzyme present on the surface of cancer cells, thereby inhibiting the production of pro-survival proteins within the cell. Marshall Edwards, Inc. has licensed rights from Novogen Limited (Nasdaq: NVGN) to bring three oncology drugs - phenoxodiol, NV-196 and NV-143 - to market globally. Marshall Edwards, Inc. is majority owned by Novogen, an Australian biotechnology company that is specializing in the development of therapeutics based on a flavonoid technology platform. Novogen, based in Sydney, Australia, is developing a range of therapeutics across the fields of oncology, cardiovascular disease and inflammatory diseases. More information on phenoxodiol and on the Novogen group of companies 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 party 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.
