Australia's Marshall Edwards says final Ph III results of phenoxodiol disappoint

Australia-based Marshall Edwards, which is majority owned by Australian biotechnology firm Novogen, says that a final analysis of its Phase III OVATURE trial of orally administered phenoxodiol in women with recurrent ovarian cancer determined that the trial did not show a statistically significant improvement in its primary (progression-free survival) or secondary (overall survival) endpoints. As previously announced, the trial was closed for recruitment before completion of enrolment with only 142 out of a planned 340 patients enrolled.

Marshall Edwards saw its shares, which were already down 43% this year, slump a further 17% premarket to A$3.32. However, Novogen fared even worse, with its stock plunging almost 53% to A$0.185 on the news, leaving the company valued at just A$18.9 million ($16 million) in extremely heavy trading of the stock.

"Owing to the fact that this trial was significantly underpowered due to the small number of patients enrolled, we were disappointed, but not entirely surprised by the final outcome," said Daniel Gold, newly-appointed chief executive of Marshall Edwards. However, he added, 'we remain confident that our investigational isoflavone platform, including triphendiol, a potentially more potent, second-generation analogue of phenoxodiol, may be of benefit to women with ovarian cancer, particularly when administered intravenously.'