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Marshall Edwards Ovarian Cancer Drug Phenoxodiol Fails In Phase 3 Trial; Shares Fall - Update

Marshall Edwards Inc. (MSHL), a company focused on clinical development of anti-cancer drugs, Tuesday said its investigational agent phenoxodiol, intended to treat recurrent ovarian cancer in women, failed to meet both primary and secondary endpoints in a late stage study. Marshall shares are currently trading down by more than 48%.

The company was developing phenoxodiol as a chemosensitizing agent in combination with platinum drugs for late stage, chemoresistant ovarian cancer and as a monotherapy for prostate and cervical cancers.

The results from the phase 3 study, dubbed OVATURE or OVArian TUmor Response trial, of orally administered phenoxodiol showed that the drug failed to meet the primary goal of progression-free survival as well as the secondary goal of overall survival.

The multi-center, randomized, double-blind trial assessed the safety and efficacy of daily phenoxodiol in combination with weekly chemotherapy drug carboplatin in women with advanced ovarian cancer versus weekly carboplatin with placebo.

The trial was closed for recruitment before completion of enrollment with only 142 out of a planned 340 patients. The trial recruited ovarian cancer patients whose cancer initially responded to chemotherapy, but had since become resistant or refractory to traditional platinum treatments.

Daniel Gold, chief executive officer of Marshall Edwards said, "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."

The company has another product candidate in its pipeline, NV-128, a novel isoflavone analogue with a mode of action distinct from both phenoxodiol and triphendiol.

"--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," Gold added.

Marshall Edwards, majority owned by Australian biotechnology company Novogen Limited (NRT.AX,NVGN), has also licensed rights from Novogen to bring oncology drugs phenoxodiol, triphendiol and NV-128 to market globally.

MSHL shares are currently trading at $2.05, down $1.95 or 48.75% on a volume of 170,476 shares on the Nasdaq.

NVGN shares closed Friday's regular trading at $1.67 in the Nasdaq.

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