Neuralstem's ALS trial on hold

Feb 22 2009

Neuralstem, Inc. has announced its spinal cord stem cell trial to treat Amyotrophic Lateral Sclerosis (ALS) is on clinical hold and that the Federal Drug Administration (FDA) has provided the Company with specific comments, questions and recommendations for modifications to its protocol.

"The FDA has presented us with their review of our entire Investigational New Drug (IND) application," said Richard Garr, Neuralstem's President & CEO. "They have asked for some additional information regarding our product manufacturing process and pre-clinical studies, as well as our novel clinical delivery injection device and technique. The Company believes that it can provide this information in an expeditious manner."

"The Agency has also requested various modifications to the protocol and eligibility criteria for patients in the trial, as well as slight changes to the timing of the surgeries," Mr. Garr continued. "We are evaluating these changes and will respond accordingly. The Agency had extensive 'non hold' comments, requests for information, and recommendations. These primarily concerned issues that will need to be addressed for final product manufacturing and testing. We are appreciative of their work in this area."

"Over all we believe the Agency's comments and recommendations are extremely helpful," Garr concluded. "We are evaluating them carefully, and expect to reach agreement with the Agency on all matters so that the trial can be approved and move forward."