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NRT - ASX Company Announcement$hmb5 THIS IS A PRIORITY ITEM7 February 2000Part 1/1--------NOVOGEN LIMITED---------------HOMEX - Sydney-------------------------Anti-Cancer Drug enters Phase 1 Clinical TrialsAustralian pharmaceutical company, Novogen Limited, today announcedthat its anti-cancer drug, NV-06, has been approved for humanclinical trialing and will enter a Phase 1 trial immediately.The initial trial is to be conducted at a major public hospital inSydney, Australia, which has granted ethical approval for the trialto proceed. The trial will provide preliminary pharmacokinetic andtolerability data on the intravenous form of the drug to enablesubsequent cancer treatment trials to be performed.NV-06 is a synthetic version of a naturally-occurring human phenolichormone discovered by Novogen scientists that has demonstratedsignificant anti-cancer activity in the laboratory against a widerange of human cancer cells including breast, prostate, large bowel,and leukaemia cancers. The company is developing the compound for thetreatment of prostate cancer, the most common cause of cancer relateddeaths in men.Professor Alan Husband, Research Director at Novogen, said theapproval for clinical trialing marked a significant milestone in thecompany's drug development program."Typically only about 1 in 1,000 new drug compounds that enterpre-clinical testing ever make it to Phase 1 clinical trials becauseof unacceptable toxicity, difficulties in synthesis or lack ofefficacy 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 infive chance of successfully reaching new drug registration stage,"Professor Husband said.Results of the trial would form part of a submission to the UnitedStates, Food and Drug Administration (FDA), for approval for humanclinical trials to be conducted in cancer patients in the USA.Professor Husband said the success of NV-06 in treating humanprostate tumours in animals and its acceptance for human testingconfirmed the original vision of Novogen's founder, Dr Graham Kelly."Dr Kelly formed the view that phenolic hormones produced in thehuman body from plant derived isoflavones are not only essential tomaintenance of human health but have a profound effect on regulatingcellular growth and differentiation," Professor Husband said."Their selective effect on cancer cells is manifested via a varietyof pathways including induction of cell differentiation, inhibitionof cell proliferation, and induction of programmed death among cancercells."The observation of a lower incidence of prostate cancer inpopulations where legumes form an important part of the diet was theoriginal trigger for the concept that legumes contain substanceswhich have important health benefits."Our subsequent discovery of the phenolic compounds which the humanbody manufactures from the isoflavones found in legumes provided thekey to a whole range of new pharmaceutical opportunities."Novogen had completed a pilot production facility for the manufactureof NV-06 to approved pharmaceutical standards and would continue tomanufacture the drug throughout the clinical development program.Novogen's Managing Director, Mr Christopher Naughton said the marketfor a prostate cancer treatment was considerable with more than300,000 new cases of prostate cancer diagnosed each year in the US,alone."There are currently no other therapeutic treatments available forprostate cancer," Mr Naughton said."Current treatments rely on drugs which simply block the action ofmale hormones, on radical surgical interventions or on radiotherapy."If successful in the ensuing clinical trials, we would expect NV-06to take a significant share of the available market."The Australian Government's R&D Start program had provided funding ofup to $2.79M to assist in the development of NV-06.Novogen expects to make submissions to the FDA for US clinical trialsapproval during the course of 2000.Novogen is listed on the ASX (code NRT) and in the US on the NASDAQ(code NVGN)Issued for : Novogen LimitedFor furtherinformation : Mr Christopher Naughton, Managing Director, Novogen Limited Professor Alan Husband, Research Director, Novogen Limited, Tel(02)9878 0088 http://www.novogen.comIssued by : Westbrook Communications Contact: David Reid Tel (02) 9231 0922 Home (02) 9569 9575ends - AAP07-02 1133Companies or Securities discussed in this article:Symbol Name AUS:NRT
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