To all:
I'm limiting myself to 4 posts/day, and so as not to exceed this limit I'll try to wrap everything up in this thread, and hopefully shed some light on my previous posts. Among the litany of mistakes I made: first, there was no monotherapy trial; secondly, the company's press release WAS all inclusive, I just failed to read it closely; and third, the quote to which I referred was from Bloomberg, not the API.
The two trials ARG-230 and ARG-231 had different outcomes. The ARG-230 trial, whose composite endpoint included: recurrent myocardial infarction; urgent angioplasty; heart failure; and death was an adjunct trial with streptokinase. The results for the composite endpoint, while encouraging, were not statistically significant. However, a subset group/indication for improvement in the left ventricular function was statistically significant with a p value of 0.03. I imagine they will conduct a phase III trial around this subset group. Their French partner, Synthelabo, is conducting a similar trial at higher dosages, the results of which are not yet available.
The second trial, ARG-231, demonstrated statistical significance in one of the composite endpoints, a 29% improvement in coronary artery reperfusion. This trial used Novastan as an adjunct to t-PA, and was conducted on 120 patients.
Both trials further established favorable safety profiles, there was evidence of dosing-related activity, and broad trends in the composite endpoint were favorable. The design of a phase II trial is not to establish efficacy, but sometimes that does become the expectation.
The only thing I did get right, I think, is that tommorrow will be an interesting day.
Sorry for the confusion,
Brian
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