Novogen subsidiary to team with Yale in cancer drug trial

Marshall Edwards Inc (MIE), a subsidiary of Australian pharma Novogen, has announced an agreement with Yale University's Department of Obstetrics and Gynaecology that will allow the Yale researchers to take the company's anti-cancer drug phenoxodiol into clinical trials for ovarian cancer.

According to Christopher Naughton, Novogen's and MIE's CEO, Yale Medical School researcher Dr Gil Mor recently demonstrated that phenoxodiol has a uniquely strong effect against ovarian cancer cells.

Mor has reported that the drug switches off the ovarian cancer cell survival mechanism, killing all of the cancer cells. The researcher also identified the specific mode of action of the drug.

"It's a very significant claim," said Naughton. He noted the findings had been submitted for publication and would be presented at the MIE annual general meeting, which is to be held in New York in October.

"This has inspired Yale to do Phase II trials," he added.

The Phase II trial will be directed by Dr Thomas Rutherford at Yale, and will be conducted at multiple sites in conjunction with an Australian university hospital.

Phenoxodiol has already been tested in a number of Phase I/II trials for a variety of different cancers. Naughton said that while the trials to date have primarily looked at safety aspects, stabilisation of tumour growth has been observed.

Significantly, no safety issues have been raised during the trials so far.

According to Naughton, the Phase II trial for ovarian cancer is likely to take place next year.

"We'd expect the trial to be in and out within 12 months, but the start date depends on the trial design, ethics committee approval and contractual details," he said, noting that 2003 was likely to be an active year for phase II trials for a number of cancer types, particularly renal carcinoma, leukaemia and prostate cancer.

"We think it's a very positive step for phenoxodiol, for the company and for biotechnology in Australia," said Naughton.

MIE was listed on the London Stock Exchange's AIM in May this year, raising $US10.1 million. The company is focused on anti-cancer drugs and phenoxodiol is it's first drug in clinical trials. It is 95 per cent owned by Novogen.