Entremed (ENMD)

[C_Peptide]

Primary efficacy endpoint...

I would read these words with caution. According to the trial description at clinicaltrials.gov ( http://www.clinicaltrials.gov/ct/show/NCT00408226 ), the trial will "... determine the antitumor activity, based on the objective response rate and median Progression Free Survival ("PFS")...".

In that case, the endpoint is met when half of the patients progress or die. Needless to say, the sooner this endpoint is met, the worse it is for efficacy. I find that the quote Dr. Sidor allowed to be attributed to her makes for uncomfortable reading: "We are pleased to have met the primary efficacy endpoint in the first stage of this study." Which loosely translates to "We are pleased that at least half of the patients in the trial have either had objective progression of their disease, or have died." If MKC-1 were the ideal cancer drug, the primary endpoint would not be met for many years.

The study began recruiting patients in the final months of 2006, and planned for 60 patients. Median progression-freee survival for advanced, pretreated NSCLC, based on recent ASCO trial reports ( http://www.asco.org/ASCO/Abstracts+%26+Virtual+Meeting/Abstracts ), is somewhere in the neighborhood of 10-15 weeks. Median overall survival is somewhere in the neighborhood of 35-40 weeks. If it took a year to accrue the patients (at a rate of 1-2 per week), then the "median" patient was recruited in mid-2007. For a drug with no effect, you might expect median progression-free survival to be reached late in 2007, and median overall survival to be reached in mid-2008. It might take longer than that if patient accrual were slow, or if the drug is effective. Until the details are released or deduced, we will not know.

Best Regards,
C-Peptide