Novogen presents phenoxodiol Phase II trial results

Preliminary Phase II trial results of Novogen's anti-cancer drug phenoxodiol have been presented at a US gynaecologic oncology conference, the company (ASX: NRT, Nasdaq: NVGN) said today.

The drug, which is being developed by Novogen's US subsidiary (Nasdaq: MSHL, LSE AIM: MSH), is being tested by Yale University researchers as a therapy for recurrent ovarian cancer.

The study showed that in women given phenoxodiol as a monotherapy, 13 out of 20 were able to complete a full three-month cycle of the twice-weekly administrations of the drug, and five were considered to have disease stabilisation.

"We didn't expect to see a major anti-tumour effect when used at this dose, so it is encouraging to see an apparent 25 per cent stability rate in such unresponsive cancers. These results give us confidence in the potential use of phenoxodiol for the treatment of ovarian cancer. We are highly encouraged by this outcome," said Rutherford, an associate professor of gynaecology and reproductive sciences at Yale, and one of the study's investigators.

And in interim results of the entire trial, eight out of nine patients treated with paclitaxel subsequent to completing the phenoxodiol trial showed a significant decline in the levels of the ovarian cancer marker CA-125. Four out of the nine patients had been defined as paclitaxel resistant. The result backs up preclinical results suggesting that phenoxodiol is capable of re-sensitising tumour cells which have developed resistance.

Novogen managing director Christopher Naughton said the result, while still preliminary, was a step in the right direction, confirming the safety and activity of the drug in humans, and bolstering its use as a chemosensitiser.

The company hopes that the drug will be suitable for use in early stage treatment of cancers including cervical, vaginal and prostate adenocarcinomas on its own, and as a chemosensitiser in later-stage cancers such as ovarian, prostate, renal and pancreatic carcinomas that have developed resistance to other chemotherapeutic compounds.

The next step for the company will be to commence a formal combination therapy trial combining low doses of phenoxodiol with other chemotherapeutic drugs to treat ovarian cancer patients.

Naughton said this trial would provide the necessary confidence to go into a pivotal trial prior to applying for market approval. The timing of such a trial would be likely to be at the end of this year, he said.

Full results of the trial would be released once the investigators had completed the analysis, and more details were likely to be released at the forthcoming meeting of the American Association for Cancer Research, Naughton said.