The primary endpoint of the trial is to determine the proportion of patients given phenoxodiol that have a 50% post-therapy prostate specific antigen (PSA) decline at 12 weeks in patients with androgen independent disease who are chemotherapy naïve (group A), and rising PSA after radical prostatectomy or radiotherapy that are androgen dependent (group B).
The clinical trial will be conducted at two sites, Yale Cancer Center and the West Haven Veterans Administration Hospital. All patients in the trial will receive 400mg of oral phenoxodiol every 8 hours daily for 28 consecutive days (one cycle).
Phenoxodiol is being developed by Marshall Edwards, as a therapy for late-stage, chemoresistant ovarian cancer and for prostate and cervical cancers, and has FDA Fast Track status. Marshall Edwards is majority owned by Novogen, an Australian biotechnology company that is specializing in the development of therapeutics based on a flavonoid technology platform.
Kevin Kelly, principle investigator for the trial and associate professor of medicine and associate director of clinical investigations, Yale Cancer Center, said: “Promising data on phenoxodiol in prostate cancer piqued our interest. This trial builds on the success of the previous prostate cancer trial with phenoxodiol. We will compare results from two types of prostate cancer patients, those with androgen independent disease and those with androgen dependent disease. If successful, development of phenoxodiol has the potential to provide a significant advancement in the treatment of prostate cancer.”