Biotech Calendar: Key Clinical Trial Dates
On the heels of the drug approval decision calendar, I've compiled a new list of clinical trial results expected before the end of the year.
This clinical trials list covers experimental drugs currently undergoing testing in phase II and phase III studies by drug and biotech companies. Unlike U.S. Food and Drug Administration drug approvals, which are more precisely timed, the release dates for data from clinical trials is bit fuzzier, so the timelines here are culled from company guidance when possible.
The working list of clinical trials expected to be completed in 2009 is fairly long, so consider the calendar below just the first installment. Expect more information on clinical trials to watch in the coming weeks.
Note: I put this calendar together using company reports, sell-side research and the BioMedTracker service from Sagient Research -- a subscription-based tool for keeping track of biotech and drug catalysts.Company: Ariad Pharmaceuticals (ARIA)
Drug/indication: deforolimus for sarcoma
Clinical trial event: phase III "Succeed" first interim analysis
Timing: second quarter The first interim analysis from this pivotal study of deforolimus, also known as AP23573, in patients with metastatic soft-tissue and bone sarcoma is driven by the number of progression events -- when a cancer starts growing or a patient dies -- that take place in the trial, but the company expects the analysis (at one-third of events) to take place later in the second quarter. This first interim analysis is likely to be just a "go/no go" decision for the rest of the trial. A more important second interim analysis will be run after two-thirds of the total progression events in the trial have occurred.
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