Novogen Limited today confirmed the commencement of the first US clinical trials of its novel anti-cancer compound phenoxodiol.

The study is being undertaken at the Cleveland Clinic Taussig Cancer Centre, in Cleveland, Ohio, one of North America’s largest cancer clinics.

Phenoxodiol, which was granted Investigational New Drug (IND) status by the US Food and Drug Administration (FDA), on 29 January 2001, is a compound which appears to kill a wide range of cancer cells while not harming healthy cells.

The trial is focussing on people with late-stage metastatic cancer.

Phenoxodiol is a signal transduction inhibitor which targets enzyme systems necessary for the growth and survival of cancer cells. These enzyme systems are either avoided or have no function in healthy cells.

Another member of this class of drug, Gleevec*, recently was given ‘fast track’ approval by the US FDA for use in treating chronic myeloid leukaemia.

Doctor Ronald Bukowski, the head of experimental therapeutics at the Cleveland Clinic Taussig Cancer Centre, said: “This whole class of drugs is interesting”.

"Phenoxodiol could be a new direction in cancer treatment," Dr Bukowski said.

The phenoxodiol trial at the Cleveland Clinic Taussig Cancer Centre builds on Phase 1b/2a human trials already underway in Australia. Australian human clinical data formed part of the successful IND application in the US.

"The Australian trials in patients with advanced metastatic cancer have provided encouraging results," Dr Bukowski said.

"These trials were intended to determine the drug's toxicity. To date, no toxicity has been found. These trials were also designed to explore the drug's anti-tumour activity and the range of tumours likely to be sensitive to phenoxodiol."

Dr. Bukowski said the drug could be used for slow-growing cancers that required extended therapy.

Phenoxodiol program director at Novogen, Dr Graham Kelly, said in vitro and clinical work to date had given researchers reason to be optimistic but emphasised that human clinical trialing was at an early stage.

“The main purpose of the US study is to learn more about the highest dose that can be tolerated and to gain a better understanding of those tumours likely to be sensitive to phenoxodiol.”

Researchers at the Cleveland Clinic ultimately expected to enrol between 20 and 30 people in the trial which will be limited to patients with late-stage metastatic cancers, other than breast cancer, in which standard chemotherapy had failed or was known to be ineffective.

Breast cancer has been excluded from investigation because Novogen is conducting research on another drug candidate, NV-50, which could have a stronger effect than phenoxodiol on this particular cancer.

Dr. Bukowski obtained his medical degree from Northwestern University Medical School. His specialty interests are medical oncology, biologic response modifiers, genitourinary cancer and cytogenetics.

The Cleveland Clinic Taussig Cancer Centre is the region's largest cancer treatment centre, where clinicians and researchers have joined forces to collaborate on cancer treatment, research and education.

The Cleveland Clinic Foundation, founded in 1921, integrates clinical and hospital care with research and education in a private, non-profit group practice.

Approximately 1,100 full-time salaried physicians at the Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specialties and subspecialties.

There were more than 51,000 hospital admissions to the Cleveland Clinic Foundation in 2000. In excess of two million people from throughout the United States and more than 80 countries were treated in outpatient visits to the Cleveland Clinic Foundation, during 2000.

Based in Sydney, Novogen is a world leader in the field of phenolic drug research and development.

[*Gleevec is a registered trademark of Novartis Pharmaceuticals Corporation.]

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