JACKSONVILLE, Fla., April 12 Sinapis Pharma is pleased to announce that it has received notice from the FDA that its Investigational New Drug application (IND) for the use of IV methamphetamine for acute stroke was approved on April 9, 2010. "We have accomplished a great deal of work for a small company on a very tight budget. We have GMP drug ready for the Phase I clinical trial and the Phase I site is prepared to begin this protocol," said Dr. Donald Picker , the company CEO. Following completion of the Phase I trial the company will agree with the FDA on a protocol to treat stroke victims and commence its proof of principle clinical trial with the world's leading stroke clinicians designing and running the program. The company also continues to produce encouraging data in animal models of traumatic brain injury, an even larger clinical indication and potential market for this drug treatment.
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 acute stroke and brain injury models.
SOURCE Sinapis Pharma, Inc.