Novogen fast-tracks ovarian cancer study

Novogen (ASX:NRT) subsidiary Marshall Edwards (NSDQ:MSHL; MSE-AIM:MSH) has outlined its plans for Phase IIb and Phase III studies of its anti-cancer drug phenoxodiol for treatment of recurrent, chemo-refractory ovarian cancer, which received fast-track status from the FDA late last year.

The company has expedited the progress of the Phase IIb/IIIa trials despite the fact that it has not yet completed enrolments in its ongoing Phase IIa trial. Results from the trial to date have shown that the drug restores chemo-sensitivity in patients whose tumours have become resistant or refractory to chemotherapeutic agents paclitaxel or cisplatin.

Marshall Edwards chairman Graham Kelly said that the positive tumour responses seen in the current study had convinced the company to move forward into Phase IIb/IIIa studies without delay.

The Phase IIb study will compare oral and intravenous dosages of phenoxodiol in up to 100 patients, and will be followed by a Phase IIIa study which will look at the performance of the drug in patients with confirmed refractory ovarian cancer in combination with the drug they have become resistant to. The endpoints of the study will include tumour response, levels of ovarian cancer marker CA125 and disease progression.

The data from the Phase IIIa study will be used to support an application to the FDA for marketing approval. A Phase IIIb study is also planned to commence once approval has been obtained to look at patient survival.