Nov 07, 2004 - 4:40 pm
FDA Grants Fast-Track Designation for Phenoxodiol for Recurrent Ovarian Cancer
WASHINGTON, DC -- November 4, 2004 -- Marshall Edwards, Inc., (Nasdaq: MSHL)(LSE AIM: MSH) today announced that the U.S. Food and Drug Administration (FDA) has granted the investigational anti-cancer drug, phenoxodiol, Fast Track status for its intended use in patients with recurrent ovarian cancer.
In approving phenoxodiol for fast track status, the letter from FDA stated:
"We are granting fast track designation for the following reasons:
1. Recurrent ovarian cancer that is resistant or refractory to platins and taxanes is a life-threatening condition
The Fast Track application submitted to the FDA contained clinical data including tumor measurements based on radiographic examination. The data are from the current Phase Ib/IIa study where patients with recurrent ovarian and primary peritoneal cancers are receiving phenoxodiol (intravenous dosage form) in combination with paclitaxel in those patients where the cancer is refractory or resistant to taxanes, or in combination with cisplatin where the cancer is refractory or resistant to platinum-based drugs.
Under the FDA Modernization Act of 1997, designation as a Fast Track product means that the drug for the designated indication is eligible for accelerated marketing approval programs. More information on the FDA Fast Track program is available at http://www.fda.gov/cber/inside/fastrk.htm
"We are developing phenoxodiol for the treatment of a wide range of cancers, but for the purpose of this Fast Track Program, we are focusing on its use as a chemo-sensitizing agent in recurrent, late-stage ovarian cancer," said Dr. Graham Kelly, Executive Chairman of Marshall Edwards, Inc.
"Ovarian cancer is one of the most devastating forms of cancer, with half of the women diagnosed with it dying within five years," Dr. Kelly said. "The FDA's decision to accept phenoxodiol into its Fast Track Program reflects the dire need to provide help for women with this deadly disease once they become resistant to standard anti-cancer drugs."
Mr. Christopher Naughton, CEO of Marshall Edwards, Inc., said, "Our goal is to continue the development of phenoxodiol as rapidly as possible for the benefit of ovarian cancer patients. We look forward to working closely with the FDA as we continue the development of phenoxodiol for this and all other indications under development."
Pre-clinical studies have shown that by targeting these anti-apoptotic proteins, phenoxodiol is able to promote death of ovarian cancer cells that are highly resistant to standard anti-cancer drugs, as well as being able to restore sensitivity in these cells to standard anti-cancer drugs such as taxanes.(3)
Phenoxodiol works selectively on tumor cells because of its interaction with the tumor-specific NADH oxidase, which is restricted to cancer cells. Clinical trials to date have revealed no significant drug related adverse side effects.
Phenoxodiol is an investigational drug and, as such, is not approved for marketing in the United States.
About the current study
Patients are being randomized to one of three treatment groups -- (i) phenoxodiol + cisplatin, (ii) phenoxodiol + paclitaxel, and (iii) paclitaxel only, converting to phenoxodiol + paclitaxel after disease progression has been demonstrated. Phenoxodiol is administered by intravenous infusion on two consecutive days per week and the second drug administered intravenously immediately following the second phenoxodiol administration. Treatment is weekly on a continuous basis until either disease progression or complete response as determined by the absence of detectable disease. There are 20 subjects per treatment group. Phenoxodiol is being administered at a dosage of 3 mg/kg; the dosages of paclitaxel and cisplatin are standard but adjustable to ensure that toxicity is no greater than Grade 1,(4) being the least toxic grade.
1. Kamsteeg M et al., 2003. Phenoxodiol -- an isoflavone analog -- induces apoptosis in chemoresistant ovarian cancer cells. Oncogene 22:2611.
2. Cheng JQ et al., 2002. Drug Resist Update 5, 131.
3. Sapi E et al., 2004. Resistance of ovarian carcinoma cells to (Taxotere) docetaxel is XIAP dependent and reversible by phenoxodiol. Oncology Research (In Press)
4. National Cancer Institute Common Toxicity Criteria (CTC version 2)
SOURCE: Marshall Edwards, Inc.