2004 - neuroinvestment
NEUROBIOLOGICAL TECHNOLOGIES
From September 2004 Issue: 'Wild Kingdom on Call'
There was a time that biotechnology appeared to be performing a kind of alchemy, aiming to translate deadly venoms of the animal kingdom into therapeutic molecules. Venomous snails, snakes, spiders, jellyfish, and vampire bats were to yield healing out of their destructive complexity. But the complexity of these highly selective proteins has been a daunting challenge for those seeking to turn them to medical benefit. Other than ziconotide, the first progeny of deadly conus venom, which itself has taken a decade to approach FDA approval, nothing has yet proven viable. That does appear to be changing, and it is in stroke that this molecular judo will take place. For years we have been waiting for an anticoagulant which might finally be usable in stroke, in contrast to tPA and its three hour window. Two are moving in development.
PAION's desmoteplase is a vampire bat saliva component analog, and it has demonstrated a nine hour window thus far as a fibrinolytic, showing success in Phase II. PAION has landed Forest as the major partner they needed to go into Phase III. They have had to work hard to find dosing that did not risk excessive bleeding, and they have used MRI screening in their trials, which does not approximate clinical reality at all stroke centers.
Neurobiological Technologies has now acquired Empire Pharmaceuticals, a company which had bought the license to Viprinex (Ancrod), an anticoagulant which had been under development by Knoll. Knoll dropped it after a US trial showed increased bleeding, after a EU trial had seemed to show safety. NTI believes that the problem related to the length of time that fibrinogen was suppressed, and can be resolved. The mechanisms are slightly different, and NTI believes that Viprinex may have a window closer to desmoteplase's nine hours than had been previously thought.
DSPA is en route to a Phase IIb, while NTI/Empire believe that they can go directly to Phase III mid-2005, provided the FDA agrees. Especially given all the documentation that Knoll's $150 million of Ancrod investment now buys, and the Knoll alumni now gathering for a reunion at NTI, Viprinex thus could conceivably be approved a year ahead of desmoteplase if all goes well.
This is not a given, but this is a very intriguing move by NTI, which badly needed a large-upside project to pursue.•
neuroinvestment.com
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