(STAMFORD, Conn.,) The US Food and Drug Administration (FDA) has advised that a clinical trial being conducted at The Cleveland Clinic, Ohio, on Novogen Limited’s anti-cancer drug, phenoxodiol, can be greatly expedited.

The FDA decision is based on early results from Australian clinical trials on the compound, in which phenoxodiol was well tolerated at doses higher than those currently being tested in Cleveland.

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.

Under US law, a new drug cannot be marketed until it has been investigated in clinical trials, the results of these trials have been submitted in a new drug application to the FDA and the FDA has approved the drug as safe and effective.

About Phenoxodiol

Phenoxodiol belongs to the new generation of anti-cancer drugs known as small molecule signal transduction inhibitors. These drugs are designed to target the faulty chemical signaling systems within cancer cells that cause the cells to misinterpret and to respond abnormally to chemical messages from the body. These misinterpretations lead the cancer cell to divide uncontrollably, to migrate uncontrollably, and to survive indefinitely. Targeting these faulty signaling systems offers the possibility of selectively switching off the cancer process with little or no impact on healthy tissues.

Phenoxodiol is unique in being the first drug to be tested in humans that targets the signalling protein, sphingosine kinase (SK). Recent studies have suggested that SK is a critically important protein in the function of normal cells, and a vital signalling protein that needs to malfunction as part of the cancer process. In normal cells, SK plays a dominant role in the signalling pathway that determines whether a cell will survive or die, with SK activity preventing cell death. In cancer cells, over-activity of SK is thought to be a key factor in preventing their death. In the laboratory, phenoxodiol has proved to be a potent inhibitor of SK activity, and therefore offers a novel and potentially important new direction in anti-cancer therapy.

Phenoxodiol currently is undergoing an extensive Phase 1b/2a clinical trial program in both Australia and the US. The early results of the first Phase 1b trials were presented to the recent major cancer conference in Miami. These showed that phenoxodiol was well tolerated by patients with late-stage cancers, with evidence of an anti-tumour effect in a number of patients despite receiving just low doses of the drug.

Novogen is a pharmaceutical company based in Sydney, Australia, with offices in Stamford, Connecticut. Novogen is a leader in the field of multi-acting, signal transduction inhibitor drugs with interests in oncology, cardiovascular, and inflammatory disease fields.

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