Praveen: Good luck with the new thread--given the sophisticated, helpful contributions you've made elsewhere, I'm sure it will be a good one.
For the sake of offering some content and opinion--by coincidence, I just put out NI's stroke review issue, so I have a fresh summary regarding Paion, FWIW:
<<Paion: In the midst of the flight from stroke drug development, Paion made the contrarian choice, to focus upon that target exclusively. Desmoteplase: (DSPA) is the recombinant version of an anticoagulant protein found in vampire bat saliva, first developed at Schering. Its clinical role is as a clot-buster in ischemic stroke. Schering lost interest in stroke and recombinant proteins at roughly the same time, and outlicensed this IP to Wolfgang Soehngen, who left Schering and formed Paion. DSPA is partnered with Forest in the US, Lundbeck in Europe. and is now in Phase III. A nine hour treatment window is in use. There have been dosing/safety issues, and Paion had to scale down its dosing considerably, leaving open the question regarding whether these lower doses will provide the reperfusion needed. DSPA showed efficacy and acceptable safety (with lower dosing) in Phase II. A dose-ranging Phase II/III trial that they claim could be pivotal--but with 60 patients per dose group, won't be--will report during 2Q:07; a second, single-dose Phase III is about to get underway, aiming at enrolling 150 patients. This seems unlikely to suffice as a pivotal trial either. In late October, Paion announced that the DSMB monitoring this almost fully-enrolled PhII/III had instructed them to stop enrollment. It appears some unspecified 'safety signal' was found in the three month followup data, and they wanted additional safety data to assess whether there is a significant issue here. Three days later, the hold was lifted, the trial resumed. But this is an odd trial strategy. >>
Harry
NeuroInvestment |
