Marshall Edwards Inc announced that the first patient had commenced treatment in the phase III "Ovature" clinical trial at The Royal Women's Hospital in Melbourne Australia.
Royal Women's is one of 60 hospitals, which will be participating in this multi-center multi-national ovarian cancer study to confirm the effectiveness of phenoxodiol in resensitizing patients to chemotherapy. Thirty of these hospitals will be in the US, 25 in Europe and 5 in Australia.
The total number of patients to be treated in this pivotal study is 470, with half to be on a treatment regime of phenoxodiol and the chemotherapeutic drug carboplatin, and half on a placebo and carboplatin.
The primary outcome of the trial is the assessment of the relative time it takes for the ovarian cancer to progress. An analysis of interim results will be possible after 95 patients have progressed with their disease.
The trial is being run under arrangements approved by the US Food and Drug Administration (FDA) known as a Special Protocol Assessment (SPA). This provides for the interim analysis of the data, which if significant can be used to support a request for grant of marketing approval.
Professor Michael Quinn of Royal Women's Hospital in Melbourne said the Royal Women's Hospital along with the Yale University Medical School had already conducted a phase II study, where phenoxodiol was shown to have a chemosensitizing effect on ovarian cancer when chemotherapy had previously failed.
"We are now hopeful that a positive outcome of this multi-center study will be a significant medical advance for thousands of women with late stage ovarian cancer whose tumours have become insensitive to the existing chemotherapeutic drugs," Professor Quinn said.
The chief executive officer of Marshall Edwards Inc, Christopher Naughton, said the phase III Ovature study was a significant milestone for the company.
"Over the next 12 to 18 months we expect the interim results from this multi-national clinical trial which may lead to the first approval for phenoxodiol," Mr. Naughton said.
Naughton said, there are also other cancer types for which phenoxodiol has shown promise and the company would be proceeding in the year ahead with a strategy to expand the drug's utility into those other cancers as both a chemosensitizer and as a monotherapy.
Ovarian cancer is the most lethal gynaecological malignancy and the fifth leading cause of cancer-related death in women in the US. The high mortality rate is due mainly to the inability to detect early disease with approximately 80 per cent of patients being diagnosed in advanced stage of disease.
Phenoxodiol is an investigational drug and, as such, is not commercially available. Phenoxodiol is a novel-acting drug that inhibits key pro-survival signaling pathways operating via sphingosine-1-phosphate and Akt. Inhibition of these pathways leads to prevention of phosphorylation of key anti-apoptotic proteins such as XIAP.
Loss of activity of these proteins restores the ability of chemoresistant tumour cells to undergo apoptosis in response to chemotherapy. The putative molecular target for phenoxodiol is a tumour-specific protein, accounting for the highly selective nature of the drug.
Marshall Edwards, Inc. has licensed rights from Novogen Limited 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.