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Monday, 07 February 2000 Novogen Anti-Cancer Drug Enters Phase I Trials The initial trial is to be conducted at a major public hospital in Sydney, Australia, which has granted ethical approval for the trial to proceed. The trial will provide preliminary pharmacokinetic and tolerability data on the intravenous form of the drug to enable subsequent cancer treatment trials to be performed. NV-06 is a synthetic version of a naturally-occurring human phenolic hormone discovered by Novogen scientists that has demonstrated significant anti-cancer activity in the laboratory against a wide range of human cancer cells including breast, prostate, large bowel, and leukaemia cancers. The company is developing the compound for the treatment of prostate cancer, the most common cause of cancer related deaths in men. Professor Alan Husband, Research Director at Novogen, said the approval for clinical trialing marked a significant milestone in the companys drug development program. Typically only about 1 in 1,000 new drug compounds that enter pre-clinical testing ever make it to Phase I clinical trials because of unacceptable toxicity, difficulties in synthesis or lack of efficacy in laboratory models of disease, Professor Husband said. NV-06 has passed all these tests. NV-06 is now at the stage where industry standards predict a one in five chance of successfully reaching new drug registration stage, Professor Husband said. Results of the trial would form part of a submission to the United States, Food and Drug Administration (FDA), for approval for human clinical trials to be conducted in cancer patients in the USA. Professor Husband said the success of NV-06 in treating human prostate tumours in animals and its acceptance for human testing confirmed the original vision of Novogens founder, Dr Graham Kelly. Dr Kelly formed the view that phenolic hormones produced in the human body from plant derived isoflavones are not only essential to maintenance of human health but have a profound effect on regulating cellular growth and differentiation, Professor Husband said. Their selective effect on cancer cells is manifested via a variety of pathways including induction of cell differentiation, inhibition of cell proliferation, and induction of programmed death among cancer cells. The observation of a lower incidence of prostate cancer in populations where legumes form an important part of the diet was the original trigger for the concept that legumes contain substances which have important health benefits. Our subsequent discovery of the phenolic compounds which the human body manufactures from the isoflavones found in legumes provided the key to a whole range of new pharmaceutical opportunities. Novogen had completed a pilot production facility for the manufacture of NV-06 to approved pharmaceutical standards and would continue to manufacture the drug throughout the clinical development program. Novogens Managing Director, Mr Christopher Naughton said the market for a prostate cancer treatment was considerable with more than 300,000 new cases of prostate cancer diagnosed each year in the US, alone. There are currently no other therapeutic treatments available for prostate cancer, Mr Naughton said. Current treatments rely on drugs which simply block the action of male hormones, or radical surgical interventions or on radiotherapy. If successful in the ensuing clinical trials, we would expect NV-06 to take a significant share of the available market. The Australian Governments R&D; Start program had provided funding of up to $2.79M to assist in the development of NV-06. Novogen expects to make submissions to the FDA for US clinical trials approvals during the course of 2000.
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