Marshall Edwards, Inc. (NASDAQ: MSHL) is planning to release preliminary results from a Phase II clinical trial of oral phenoxodiol in patients with early and advanced stage prostate cancer. The results will be presented by the Yale researchers, who were responsible for the study, at the ASCO Genitourinary Cancers Symposium in Orlando, Florida; February 26-28, 2009 became available in abstract form on the ASCO website yesterday.
Kevin Kelly, DO, Associate Director, Solid Tumor Investigation, Yale Cancer Center, led the research.
The information will be released at a poster presentation which will review data supporting the anti-tumor effects of phenoxodiol as studied in patients with advanced prostate cancer (Group A) and in patients with early stage, pre-metastatic disease where prostate specific antigen (PSA) levels were rising after radical prostatectomy or radiation therapy (Group B). Twenty five (25) patients have been treated to date. Sixteen (16) were in Group A and nine (9) in Group B.
The very disappointing (my comment) interim analysis shows that among Group A patients (advanced patients), one (1) remains on therapy without disease progression for greater than 6 months and one (1) patient had a greater than 50% post-therapy PSA decline, while 5 patients in Group B (biochemical recurrence) fifty six percent (56%) had stable disease for a median time of 3 months. Since this was a phase II trial, there was no control group to compare time to progression.
According to Dr. Kelly, “Oral phenoxodiol was very well tolerated with no severe adverse events reported to date. More importantly, we observed some evidence of clinical activity, especially in the early stage disease group, in terms of holding disease progression in check,” said Dr. Kelly. “Further studies evaluating the impact of phenoxodiol on serum cytokines will be explored at the completion of the trial.”
My opinion- Looks to me like this much-heralded trial was a big flop. See additional information about this trial on this blog, “A Clinical Trial Worth Considering” dated December 12, 2007.
Joel T Nowak MA, MSW
Joel- I totally agree with your comments,though preliminary, these are very disappointing results!