(KERX - Get Report)
colon cancer drug perifosine will fail when results from a phase III clinical trial are announced early next year.
Says who? I say, but noted University of Chicago oncologist and professor Dr. Mark Ratain shares my bearish outlook.
"Everything tells me that the perifosine trial is going to be negative," Ratain told me in a phone conversation Thursday. [Ratain has no financial conflicts related to Keryx.]
An email from W. Rubin asking for my prediction of the perifosine colon cancer study prompted a phone call to Ratain to get his opinion. The question is especially relevant in the context of an editorial Ratain and I co-authored and published last month in the
Journal of the National Cancer Institute
(JNCI) which demonstrated a
100% failure rate for phase III cancer drug trials conducted by micro-cap cancer drug developers
Our JNCI paper analyzed the outcomes of 59 phase III clinical trials of cancer drugs going back 10 years, stratified by the market value of the companies four months prior to trial results being announced. What we found was a remarkable difference between the
market values of companies that had positive and negative announcements
Specifically, the median market capitalization was approximately 80-fold greater for the companies with positive trials vs. companies with negative trials. There were no positive trials among the 21 micro-cap companies (companies with less than $300 million market capitalization) whereas 21 of 27 studies reported by the larger companies analyzed (greater than $1 billion capitalization) were positive.
Keryx today carries a market value of approximately $200 million, which makes it a micro-cap cancer drug stock per our definition. The phase III colon cancer study of perifosine is also expected to report top-line results in the first quarter of next year, or approximately four months from now.
Ergo, Keryx is running headfirst into bad news real soon. Perifosine will be a bust.
I expect some of you -- maybe most of you -- will scoff at our prediction, particularly because perifosine demonstrated a significant survival advantage (17.7 months vs. 7.6 months) in a randomized, controlled phase II colon cancer study -- albeit a study that enrolled just 38 colon cancer patients. Still, these perifosine data, which have been presented at the big ASCO cancer meeting and were published last week in the Journal of Clinical Oncology, seem to justify confidence in a successful phase III study.