Ovature trial cut short
Wednesday, 15 April, 2009
Marshall Edwards, the US subsidiary of Sydney company Novogen, will cut short its Phase III ovarian tumour response or Ovature trial to save money.
The trial was expected to recruit 340 patients and is being undertaken in 75 hospitals around the world. Under a special protocol assessment from the US FDA, an interim analysis is allowed after 95 patients fully completed the trial.
In a press release today, Novogen announced that new patient recruitment will cease and interim analysis will take place on data from the 141 completed and current patients.
The trial involves Marshall Edwards’ lead candidate phenoxodiol, which is being tested in platinum-resistant patients. The drug is also in Phase II trials in prostate cancer and in another ovarian cancer study in conjunction with docetaxel (Taxotere, marketed by Sanofi-Aventis).
The money saved will be used to fund the other phenoxodiol trials as well as a clinical program for triphendiol, which is targeted at pancreatic cancer, and Novogen’s early stage candidate NV-128, which inhibits two mTOR pathways.
Marshall Edwards has first right of refusal to licence this drug, which is being targeted at ovarian and non-small cell lung cancer.
Last month, Novogen also announced it was putting its cardiovascular and anti-inflammatory pipeline on hold until the economic climate improves.
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