Phenoxodiol belongs to the new generation of anti-cancer drugs known as small molecular signal transduction inhibitors that target abnormal signalling processes in cancer cells. Switching off these abnormal processes causes the cancer cells to stop growing and/or to die. Non-cancer cells with normal signalling processes generally are not affected.

"Because leukemia cells are easier to sample, this trial will give us the opportunity to understand oral phenoxodiol's biological affects on cancer cells more expeditiously," said Dr Graham Kelly, Phenoxodiol Program Director, Novogen Limited.

Phenoxodiol is unique in this class of anti-cancer drugs in targeting a protein known as sphingosine kinase (SK). SK has been identified as a key signalling protein on which the cancer cell is highly dependent for its growth and survival. Phenoxodiol blocks the activity of this protein, causing the cancer cell to stop growing and to die. Phenoxodiol is the first SK inhibitor to be tested in humans.

Phenoxodiol currently is undergoing four Phase Ib/IIa clinical studies in patients with late-stage cancer. Three of these studies are using an intravenous dosage form in patients with various solid tumours including prostate, lung, pancreatic and renal carcinomas and melanoma. One of these studies is being conducted at the Cleveland Clinic in the US, with all other trials being conducted in Australia. A fourth study uses an oral form of phenoxodiol in patients with prostate carcinoma.

This new fifth study will test the safety and efficacy of the oral dosage form in patients with various forms of cancer of the blood, including patients with chronic myeloid leukemia who have failed to respond to another signal transduction inhibitor, Gleevec®*.

Under US law, a new drug cannot be marketed in the US 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.

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

* (imatinib mesylate) Gleevec is a registered trademark of Novartis Pharmaceuticals Corporation

<<< back