Phenoxodiol trials: focus on ovarian not prostate cancer
Phenoxodiol’s fast track status at FDA generates a lot on interest among men with advanced prostate cancer. But despite evidence that Phenoxodiol delays progression in hormone refractory prostate cancer, is the fast track to FDA approval petering out?
An inquiry this week from a patient in Scandinavia, who is taking chemo for advanced prostate cancer, led us to call Novogen, where a spokesman said that although phenoxodiol is still fast tracked for prostate cancer, the company is concentrating its resources on a clinical trial for ovarian cancer. Phenoxodiol is being tested for women with advanced ovarian cancer as chemo sensitizer along with carboplatin, This is the OVATURE (OVArian TUmor REsponse) Study, official Title: Multi-Center, Randomized, Double-Blind, Phase III Efficacy Study Comparing Phenoxodiol in Combination With Carboplatin Versus Carboplatin With Placebo in Patients With Platinum-Resistant or Platinum-Refractory Late-Stage Epithelial Ovarian, Fallopian or Primary Peritoneal Cancer Following at Least Second Line Platinum Therapy.” The study begins this month and is expected to recruit 470 patients.
Given the realities of clinical trials, a Novogen spokesman told us today, the company believes that by focusing their attention on this ovarian cancer Phase III trial they are following “the shortest route” to FDA approval of phenoxodiol.
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