Novogen to begin trials with phenoxodiol-derivative

By Melissa Trudinger
Wednesday, 12 May, 2004

Novogen (ASX: NRT) has received approved to commence a Phase I clinical trial at Sydney's St George Hospital of its second anti-cancer drug NV-18, a derivative of the company's first generation drug phenoxodiol.

The trial will look at bioavailability, pharmacokinetics and safety of the drug in six patients with solid tumours. Three methods of administration -- oral, bolus intravenous injection, and slow intravenous injection -- will be tested on the patients over an eight week period.

Preclinical studies performed in Australia and in the US have shown that NV-18 is active against a broad range of tumours, and shows particularly potent activity against melanoma and cholangiocarcinoma (cancer of the gall bladder). The company plans to evaluate the drug as a monotherapy for these two cancer types, and as a chemo-sensitiser for standard anti-cancer agents.

Novogen's US subsidiary Marshall Edwards has an option for first and last rights to license compounds developed by Novogen once they enter the clinic, and Novogen managing director Chris Naughton said this option would now be activated for NV-18.

Naughton said the announcement was a very positive step for the company.

"To have a follow-on drug in clinical trials when the first-generation drug is showing such good results [in the clinic] is great news. [With all of the results we have from phenoxodiol], we really have a reasonable idea of what to expect from NV-18," he said.

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