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NOVOGEN ANTI-CANCER DRUG TRIALS ADVANCE
Australian pharmaceutical company, Novogen, today announced that its anti-cancer drug, NV-06, has advanced to its next stage of clinical trialing.
The Company has received approval for NV-06 to enter a Phase I-II trial and that trial now is to commence at a major Australian teaching hospital.
The trial will involve 36 patients with solid metastatic cancers. The cancers will be predominantly prostate and breast cancers that have failed previously to respond fully to standard anti-cancer drugs.
This trial involves a treatment strategy of single weekly injections, a strategy that allows large doses of drug to be given.
Patients will receive single weekly injections for 12 weeks.
Novogen announced in June 2000 that it had successfully completed a Phase 1a study that involved administering a single intravenous injection of NV-06 to cancer patients. That study established that the drug was well tolerated by the patients and was chemically stable in the bloodstream.
The objectives of this new trial are to assess the effects of longer-term therapy on safety and cancer progression.
NOVOGEN ANNOUNCES COMPLETION OF NV-06 INFUSION STUDY
Novogen also announces the completion of a Phase 1a study of NV-06 delivered by infusion.
Constant infusion is an alternative treatment strategy to single weekly injections and aims to deliver a steady, low level of drug on a long-term basis. Certain types of cancer respond well to this form of treatment.
This Phase 1a study was successful in confirming that a steady-state blood level of NV-06 could be maintained by chronic infusion and that the procedure was well tolerated.
Results of the current studies 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.
NV-06 is a new class of anti-cancer drug that has been designed to target cancer cells while sparing normal cells.
In the laboratory, NV-06 displays potent anti-cancer activity against a wide range of human cancers, but shows little or no activity against non-cancer cells. Pre-clinical studies have provided the drug with a high safety profile.
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.
NV-06 is being developed with the assistance of the Australian Governments START research and development program.
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