JACKSONVILLE, Fla., May 24 /PRNewswire/ -- Sinapis Pharma, Inc. has successfully completed a Bridge financing to continue to support its drug development program. Sinapis Pharma has discovered and is developing a novel therapeutic approach to neuronal protection using its intravenous methamphetamine technology. The company has strong pre-clinical data in stroke and traumatic brain injury animal models conclusively demonstrating a 12-hour therapeutic window and multiple pathway neuroprotection.
The current financing, when added to existing corporate funds, will allow the company to conduct its Phase I pharmacokinetic/safety trial in humans with trial completion anticipated in Q3 2010. The company anticipates agreeing on a Phase II proof of concept study protocol with the FDA in late 2010, with Phase II trial initiation in early 2011.
Dr. Donald Picker, Sinapis CEO, relates: "We have passed several very significant milestones on a limited budget, and are excited about moving our neuroprotective strategy into human trials. We have a rapid, inexpensive development pathway to proof of principle in man within 24 months due to the drug's previous human use for other indications, and anticipate being the first neuroprotective drug to enter stroke and traumatic brain injury clinical trials with solid 6-12 hour pre-clinical data."
Sinapis Pharma, Inc. (www.sinapispharma.com) is an early stage biotechnology company whose lead compound methamphetamine, as a low-dose intravenous infusion, has shown remarkable pre-clinical efficacy in stroke and brain injury models.