Miljenko called this one, though perhaps Alexion might be another comparable . . .
>>DENVER, March 25 /PRNewswire-FirstCall/ -- Myogen, Inc. (Nasdaq: MYOG - News) announced today preliminary results of EMOTE, a Phase III study of enoximone capsules in 201 patients with the most advanced stages of chronic heart failure who are dependent on intravenous (i.v.) inotrope therapy. The study was designed to evaluate enoximone capsules as effective treatment to wean patients off of i.v. inotrope therapy and potentially support the two ongoing Phase III pivotal studies, ESSENTIAL I & II.
Analysis of the primary endpoint, wean success at 30 days, demonstrated a wean success rate of 61% in the enoximone-treated group and 51% in the placebo-treated group. This difference did not reach statistical significance (p = 0.171). The key secondary endpoints, which also evaluated wean from i.v. inotrope therapy, but over time rather than at a fixed 30-day time point, were achieved, demonstrating a therapeutic benefit. The safety results demonstrated no statistical difference in serious adverse events or mortality between the groups receiving placebo or enoximone capsules. A total of 38/101 patients died in the enoximone treated group compared to 31/100 patients in the placebo treated group (p = 0.335).
The first secondary endpoint, time to death or re-initiation of i.v. inotrope therapy, a measure of wean success over time, demonstrated benefit in favor of enoximone versus placebo for the 60-day (p= 0.012), 75-day (p = 0.016) and 90-day (p = 0.041) periods, but not for the 182-day (p = 0.188) period. Mean total days on i.v. inotrope therapy over the course of the study, another secondary endpoint, were 28 days in the enoximone-treated group as compared to 49 days in the placebo-treated group (p = 0.049).
"The higher than expected placebo wean rate meant that it took longer to see the therapeutic benefit of enoximone than we had anticipated based on results from prior Phase II studies," said Dr. Michael Bristow, Chief of Cardiology, University Colorado Health Sciences Center and Chief Science and Medical Officer of Myogen. "The data show that as patients progressed beyond 30 days, those patients weaned with placebo had to be re-initiated on i.v. inotrope therapy sooner and at a higher rate than patients weaned with enoximone. The effect of enoximone was more durable than anticipated, and that translated into a 43% reduction in the mean number of days that patients on enoximone required i.v. inotropes."
"Although the primary endpoint was not achieved, given the results of these secondary endpoints, which are more comprehensive measures of wean success, I believe the objective of this study was achieved, namely, that enoximone capsules lowered the requirement for intravenous inotropes in patients with advanced chronic heart failure," said J. William Freytag, Chairman, President and Chief Executive Officer of Myogen. "I am also encouraged by the safety results of this study."
The Company plans to provide further details of EMOTE results after all data analyses are completed and will submit the data for presentation at a scientific meeting.
Conference Call
J. William Freytag, President and CEO, and other members of Myogen's senior management will discuss the EMOTE results via webcast and conference call on Friday, March 26, 2004 at 8:00 am Eastern. To access the live webcast, please log on to the company's website at www.myogen.com and go to the Investor Relations section. Alternatively, callers may participate in the conference call by dialing 800-219-6110 (domestic) or 303-262-2175 (international). Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through Friday, April 9, 2004. Callers can access the replay by dialing 800-405-2236 (domestic) or 303-590-3000 (international). The pass code is 575227#.<<
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The really worrisome thing is that this isn't the drug or trial Miljenko was referring to. He was talking about this:
Message 19667171
So another failure could loom for this company. That's pretty tough when the company is in expiration hell. MYOG was off 25% after the bell, so it should make an appearance on the firesale thread tomorrow. But I doubt any SI biofreaks will buy the weakness.
Cheers, Tuck |
