Replies to post #41145 on Biotech Values

[daved]

Here is a quote:

"The study protocol and entry criteria for MEND-CABG II closely follow that of the Phase II MEND-CABG study. MEND-CABG was a Phase II study involving 901 patients that evaluated MC-1 versus placebo in patients undergoing CABG surgery. The 250 mg dose of MC-1 had a 37.2% reduction in the composite of cardiovascular death, non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml), and non-fatal stroke versus placebo (p equals 0.028). The reduction in the composite endpoint was driven by a significant 46.9% decrease in the incidence of non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml) with the 250 mg dose of MC-1 versus placebo (p equals 0.008). The clinical results reported at POD 30 were maintained throughout the 90 day follow up period (POD 90). Safety analysis included in the MEND-CABG study demonstrated MC-1 was safe and well tolerated. The incidence of adverse events in the study was comparable across both treatment and control groups."

Eliminating the stroke component eliminates a needless variable that proved to be very inconclusive. That moves the stat sig closer to the .008 stat sig and farther away from the .028 stat sig. At either figure the drug will meet the primary endpoint. Ergo, I think it's a slam dunk with just triple the patients.

Do you disagree or are you just fishing for clarity?

Dave

[daved]

re MCU p2 results link:

http://www.findarticles.com/p/articles/mi_m0EIN/is_2005_Dec_5/ai_n15894504

Note that the primary endpoint moves from a stricter definition of MI and a link to stroke to an SPA agreed looser definition and no reference to stroke in P3.

I was pretty sure that the FDA would have insisted on the new post 2004 definition of MI which includes troponin measurement. I made the call to the company to clarify the SPA for P3. My assumption proved untrue. Troponin is not even measured in the trial.

Several recent SPA approved trials are using the peak CK-MB 100ng/ml definition of MI. That is what Medicure is using with FDA agreement. Hogan says the newer definition that includes troponin levels is more appropriate to ACS and that the higher Peak CK-MB numbers are the current gold standard definition for those who have had are have been supposed to have had a previous MI.

Dave