FDA says Novogen can speed up phenoxodiol trials

The US Food and Drug Administration has told Australia's Novogen that aclinical trial of its experimental anticancer compound phenoxodiol "can be greatly expedited." The decision is based on earlier results from Australian trials on the compound (Marketletter June 25), in which phenoxodiol was well-tolerated at doses higher than those currently being tested in a trial in the Cleveland Clinic, USA.

As a result of the FDA decision, phenoxodiol can now be administered to US cancer patients in higher doses sooner than would otherwise have been scheduled under the previously-approved protocol. Phenoxodiol belongs to the new generation of anticancer drugs, small-molecule signal transduction inhibitors, which are designed to target the faulty chemical signaling systems within cancer cells. Novogen claims that phenoxodiol is unique in being the first drug to be tested in humans that targets the signalling protein, sphingosine kinase, "and therefore offers a novel and potentially important new direction in anticancer therapy."

News of the FDA's decision helped to push Novogen's shares, which are listed on the Australian Stock Exchange, up to a three-month high on November 19, closing at just over A$1.56.