Clarification of Media Reports Re Phenoxodiol Clinical Studies

Novogen Limited today announced that, contrary to media reports, clinical studies of its novel anti-cancer compound, phenoxodiol, are well advanced.

Two Phase 1a human studies which commenced at Australian teaching hospitals during 2000, have been completed and two Phase 1b/2a human clinical trials are in progress.

Data from the initial Australian trials formed the basis of the successful application before the US Food and Drug Administration for the granting of Investigational New Drug (IND) status to phenoxodiol on 29 January 2001, clearing the way for human clinical trialing to commence in the US.

Currently, there are two Phase 1b/2a human clinical trials underway at Australian teaching hospitals.

These studies involve the administration of phenoxodiol to cancer patients with late-stage metastatic disease on an “intent to treat” basis.

These patients can only be enrolled into the studies if they have failed all standard forms of therapy or they have cancers known to be unresponsive to standard therapies. Phenoxodiol is the only treatment administered.

The purpose of these studies is to define the toxicity (if any) of phenoxodiol, the highest dose of the compound that can be tolerated and to determine the range of cancers sensitive to its effect.

As these clinical studies are conducted independently of Novogen, by the teaching hospitals concerned, results are made available publicly at the discretion of the trial co-ordinators.

It is intended to use this data to design Phase 2b studies to be conducted during 2002, using large numbers of patients with specific types of cancer.

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