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Novogen 'Ovature' trial hit by crisis
April 15, 2009 - 2:54PM
Biotech Novogen Ltd's US subsidiary has decided to undertake an interim analysis of its phase III "Ovature" trial, saying slowing patient recruitment rates and the global financial crisis has made it imprudent to fund the trial to completion.
The Ovature (Ovarian Tumour Response) study is trialling the anti-cancer drug phenoxodiol in women with advanced ovarian cancer to determine its safety and effectiveness when used in combination with chemotherapy drug carboplatin.
Novogen said its US subsidiary, Marshall Edwards Inc, had announced that new patient recruitment to the Ovature trial would cease and available data from the 141 completed and current patients would be analysed for safety and efficacy outcomes.
"The company has decided to assess these data from the Ovature trial at this time as the current downturn in the global financial markets makes raising further equity or debt in the near term to fund the trial through to completion most unlikely," Marshall Edwards said....cont'd
The title of this post is very misleading. More accurately, the problem centers upon a flawed trial design making it impossible to reach full recruitment of 340 patients within a reasonable time. Existing data will be analyzed now rather than draining funds for years of additional trial recruitment. The patient criteria were too rigorous to conduct and effective trial.
ReplyDeleteUnless you can explain in detail further, then your comments are difficult to interpret. Clinical trial enrolment is rigorous and in particular should be not only for patient safety but also for efficacy of the results. Anonymous? hmmmm
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