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Tuesday, 06 June 2000 Anti-Cancer Drug Passes First Clinical Hurdle These initial trials were conducted at a major public hospital in Sydney, Australia, to provide data on blood level changes over time, and the tolerability of the drug in humans. NV-06 was delivered as a single intravenous injection to a small number of cancer patients. Novogens Executive Chairman, Dr Graham Kelly, said the initial results were encouraging. NV-06 behaved in the human blood stream just as predicted from pre-clinical studies, Dr Kelly said. The result marked an important milestone in the Companys drug development program. We have now advanced to the stage where we can initiate the phase 1b trial involving repeated daily injections in cancer patients. Dr Kelly said NV-06 was now in human clinical trials as a treatment for prostate cancer. The successful treatment of prostate cancer remains a major challenge in medicine and patients are in need of an effective well-tolerated therapy. He added that Novogen considers that NV-06 may also prove effective against a number of other cancer types. Novogen has completed a pilot production facility for the manufacture of NV-06 to approved pharmaceutical standards and will continue to manufacture the drug throughout the clinical development program. The Australian Government's research and development START program has provided funding of up to $2.79 million to assist in the development of NV-06. Results of the trial will 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.
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