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Monday, 08 January 2001 Second Phenoxodiol Study Begins Australian pharmaceutical company, Novogen Limited, today announced that it has received approval to commence the next phase of development of its anti-cancer drug, phenoxodiol (previously code-named NV06). This second Phase 1b study will be conducted at a major Sydney teaching hospital. This new study will measure the safety and anti-cancer effectiveness of phenoxodiol when administered by continuous intravenous infusion over seven days. The study will involve patients with solid cancers whose cancers have become unresponsive to standard anti-cancer drugs. Approximately 18 patients will be enrolled in the study. Phenoxodiol currently is undergoing its first Phase 1b clinical study in an Australian hospital in patients with solid malignant tumours including prostate cancer. That study, which commenced in the final quarter of 2000, is investigating the safety and anti-cancer efficacy of phenoxodiol when injected intravenously once weekly for 12 weeks. This second Phase 1b study will investigate the alternative approach of maintaining constant blood levels of phenoxodiol over a sustained period of time. Phenoxodiol is a novel, cytotoxic, anti-cancer drug that arrests cancer cell growth and restores apoptosis (programmed cell death). Phenoxodiol acts through a variety of mechanisms including the inhibition of a number of cellular enzyme systems, including topoisomerase 2 and protein tyrosine kinases, that are integral to the development of cancer. Inhibiting these enzyme systems is recognised as a key factor in preventing the growth of cancerous cells. While inhibition of topoisomerase 2 and/or kinases is an important target of anti-cancer drug development, the novelty of phenoxodiol lies in its ability to combine a high degree of potency in this regard, with no known adverse effects on normal cells. That novelty is further extended by phenoxodiol possessing a number of other anti-cancer mechanisms that appear to contribute to the overall anti-cancer effect. Phenoxodiol displays equivalent activity in the laboratory against a wide range of human cancer cell types including prostate and colon cancer cells, and melanoma, leukaemia and neuroglioma cells. In the clinical trial program embracing the two Phase 1b studies, patients with a wide variety of cancer types are being recruited in order to assess the range of anti-cancer activity of phenoxodiol. Novogen has a pilot production facility for the manufacture of phenoxodiol to approved pharmaceutical standards and will continue to manufacture the drug throughout the clinical development program. Phenoxodiol is being developed with the assistance of the Australian Governments START research and development program. Novogen is a leader in the field of phenolic drug development with a pipeline of drugs based on a phenolic (or flavonoid) ring structure. Phenolic compounds are naturally-occurring compounds in humans that have been recently discovered to regulate a wide range of functions of human cells and that Novogen believes represents a previously undiscovered class of human hormone.
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