Novogen establishes Australian site for breast cancer study

The Royal Women’s Hospital in Melbourne has been announced as one of two international sites for a phase II clinical trial of phenoxodiol, the promising chemotherapy-boosting compound phenoxodiol, developed by Marshall Edwards (LSE AIM: MSH, NASDAQ:MSHL), a US subsidiary of Sydney pharmaceutical company Novogen (ASX: NRT, NASDAQ: NVGN).

The hospital has already begun enrolling volunteer patients with late-stage ovarian cancers that have become refractory - unresponsive - to the frontline chemotherapy agents for ovarian cancer, paclitaxel and cis-platin.

Like the US clinical trial at Yale-New Haven Hospital in Connecticut, the Melbourne study will investigate the ability of phenoxodiol to boost the activity of paclitaxel and cis-platin as well as to restore the sensitivity of ovarian cancers that have become refractory to standard chemotherapy.

In an earlier Phase 1/2 trial, Yale-New Haven Hospital researchers found that low-dose phenoxodiol inhibited tumour growth in women with late-stage ovarian cancer when used alone.

In April this year, Yale Medical School researchers reported at the American Association of Cancer Research conference that four of five ovarian-cancer patients classified as refractory to paclitaxel had shown a substantial response after phenoxodiol therapy.

In the Melbourne trial, the women will be randomly assigned to one of three treatment arms: paclitaxel only, paclitaxel plus phenoxodiol, and cis-platin with phenoxodiol.

According to the Marshall Edwards announcement, the paclitaxel-only treatment has been included to confirm that the patients’ cancers are refractory, as required for regulatory approval of such a drug. The women will be offered phenoxodiol/paclitaxel combination once their cancers are confirmed as refractory to paclitaxel alone.

In in-vitro tests against a diverse range of refractory cancer cell lines, phenoxodiol has been found to restore chemosensitivity by switching off a protein, XIAP2, which prevents cancerous cells undergoing apoptosis - programmed cell death.

Dr Michael Quinn, who is leading the RWH study says the hope is that the study will benefit women with ovarian cancer who have become unresponsive to front-line chemotherapy drugs.

“Currently, we can offer nothing in the way of therapy for these patients,” Dr Quinn said, “But the promising clinical response that [Yale] Medical School doctors obtained with phenoxodiol in refractory patients gives us cause to hope that that will change.”