The FDA previously granted fast track status to the overall Ancrod development program for acute ischemic stroke and now has additionally confirmed fast track status for this clinical protocol.
Paul Freiman, president and CEO of Neurobiological Technologies (NTI), said, “We anticipate patient enrollment in the trial to begin within the next few weeks. Our goal was to initiate the phase III program in the third calendar quarter of 2005 and we fully expect to achieve that goal.”
Derived from the venom of the Malayan pit viper, Viprinex is a thrombin-like enzyme that is highly specific to fibrinogen. When administered systemically, Viprinex has been shown to rapidly deplete plasma fibrinogen (it is a defibrinogenating agent).
The effects are anticoagulation, improved blood viscosity and a secondary fibrinolytic or clot lysing action. Combined, these effects constitute a perfusion strategy that in prior human clinical trials appears to restore and enhance oxygen flow to the affected area of the brain.
NTI obtained rights to Viprinex when it purchased Empire Pharmaceuticals in July 2004.