Acorda Therapeutics, Inc. (Nasdaq:
) today announced that the U.S. Army Medical Research and Material Command (USAMRMC) has awarded the Company a $2.67 million research contract to support development of AC105, a propriety magnesium formulation being studied as a treatment for acute spinal cord injury (SCI).
The contract will help support a Phase 2 clinical trial designed primarily to assess the safety and tolerability of AC105 in people with acute SCI. The Company plans to open enrollment for this study in the first half of 2013.
“Spinal cord injuries often result in severe, lifelong disability, and primarily occur in young people. This leads to long-term care and quality of life issues for the person with the injury, as well as for their family and the healthcare system as a whole,” said Anthony Caggiano, M.D., Ph.D., Acorda’s Vice President of Research and Development. “We are pleased to be collaborating with the U.S. Army on this project to determine if AC105 can improve outcomes in SCI. It is also a privilege for us to be working on a therapy that may help those who have been injured in the line of duty.”
In preclinical studies, AC105 demonstrated neuroprotective properties and improvement of locomotor function in SCI when therapy was initiated within several hours of injury. The U.S. Food and Drug Administration (FDA) granted Fast Track designation for AC105 to improve functional recovery of acute SCI patients. Acorda expects to apply for FDA orphan drug designation for the acute treatment of SCI and will explore orphan drug designations in Europe and in other parts of the world.
About Spinal Cord Injury (SCI)
Spinal cord injury (SCI) refers to any injury to the spinal cord that is caused by trauma, such as a motor vehicle accident, fall or sports injury. According to the National Spinal Cord Injury Statistical Center (NSCISC), there are approximately 270,000 people in the United States living with a spinal cord injury. Each year, there are approximately 12,000 new injuries reported in the United States, the majority of which are males. Spinal cord injuries primarily affect young people, with 50-70% occurring in those aged 15-35.