Entremed (ENMD)

[C_Peptide]

Looking back to the preliminary MKC-1 trial data from ASCO, ( http://www.asco.org/ASCO/Abstracts+&+Virtual+Meeting/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=33394 ) is appears that as of the January 8, 2008 abstract deadline, 8 patients had been enrolled in the phase-1 dose-finding portion, which defined a dose of 75mg/m2 bid for the first 14 days of each 21 day cycle, and 11 patients had been enrolled in the phase-2 portion, of which one had stable disease for 8 months. Hopefully accrual picked up once the dose was defined and very preliminary positive signs were observed. In a population where the median time to progression is 12-15 weeks, it does not take very long to demonstrate something significantly better than that.

The most pessimistic scenario consistent with the data is that accrual was slow, only 31 of the planned 60 patients have been accrued so far, and all but one of them progressed or died in a few weeks, but not so fast that the data safety monitors halted the trial early, thus meeting the primary efficacy endpoint in a very lousy way.

The most optimistic scenario consistent with the data is that accrual was fast, about 2 per week, and all 60 patients were accrued by around July 1st, with the median patient accrued around April 1st. If 30 of them were cured oughtright, and it took until last week for the remaining 30 to progress, then that would be a median progression free survival of about 30 weeks, which would be a moonshot result.

The truth is probably somewhere in between.

Best Regards,
C-Peptide