AC105 improved motor function after spinal cord injury in preclinical studies
ARDSLEY, NY, USA I September 25, 2013 I Acorda Therapeutics, Inc. (ACOR) today announced that the first patient has been enrolled in a trial of AC105, its proprietary magnesium formulation for the treatment of spinal cord injury (SCI). This Phase 2 trial will evaluate the safety and tolerability of the drug in people with traumatic SCI, and also incorporates several exploratory efficacy measures.
“In preclinical studies, AC105 improved motor function in SCI when therapy was initiated within a few hours after injury,” said Andrew R. Blight, Ph.D., Acorda Therapeutics’ Chief Scientific Officer. “Spinal cord injuries often result in severe, lifelong disability, so we’re excited to explore the potential to improve outcomes for people who suffer these very serious injuries.”
Magnesium’s neuroprotective properties are well established in the laboratory; however, the tolerable dosage range in the clinic is relatively narrow, which has made it a challenge to develop a practical therapy. Preclinical research shows that AC105’s formulation helps deliver magnesium to the injury site within the CNS, thereby providing a protective effect, but without requiring higher levels in the blood, which might result in significant side effects.
The primary objective of this double-blind, randomized and placebo controlled study is to evaluate the safety and tolerability of AC105 in people who have suffered an SCI. The study also includes several exploratory efficacy measures, including standard scales used to assess motor function. Participants in the trial will receive six intravenous doses of AC105 or placebo over 30 hours; the first dose to be administered within 12 hours of the injury.
The U.S. Food and Drug Administration (FDA) granted Fast Track designation for AC105 to improve functional recovery following acute SCI. The Company received a $2.67 million research contract from the U.S. Army Medical Research and Material Command to support the study. Acorda may potentially expand its AC105 program into other neurological injury indications.
Additional details on this clinical study, including enrollment criteria, can be found at: http://www.clinicaltrials.gov/ct2/show/NCT01750684
About Spinal Cord Injury
Spinal cord injury (SCI) is usually 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 between 183,000 and 230,000 people in the United States, and approximately 2 million people worldwide living with a spinal cord injury. Each year, there are approximately 11,000 new injuries reported in the United States. Males account for the majority of spinal cord injury patients with 50-70% of those occurring in those aged 15-35.
The costs of living with SCI can be considerable and can vary greatly due to the severity of injury. Long-term complications from SCI can include neurologic impairments resulting in paralysis, loss of sensation and disruption of any body system controlled by nerves originating at or below the area of the injury. Average annual medical cost for an SCI patient is $15,000-30,000 per year and the annual direct and indirect costs of SCI are estimated at $9.7 billion in the U.S. alone. There are currently no FDA-approved therapies indicated to treat, mitigate, or reverse SCI.
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a biotechnology company focused on developing therapies that restore function and improve the lives of people with neurological conditions.
Acorda markets three FDA-approved therapies including: AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg, a treatment to improve walking in patients with multiple sclerosis (MS); ZANAFLEX CAPSULES® (tizanidine hydrochloride) and Zanaflex tablets, a short-acting drug for the management of spasticity; and QUTENZA® (capsaicin) 8% Patch, for the management of neuropathic pain associated with postherpetic neuralgia. AMPYRA is marketed outside the United States as FAMPYRA® (prolonged-release fampridine tablets) by Biogen Idec under a licensing agreement from Acorda.
Acorda has one of the leading pipelines in the industry of novel neurological therapies. The Company is currently developing six clinical-stage therapies and one preclinical stage therapy that address a range of disorders including post-stroke deficits, epilepsy, cerebral palsy, stroke, peripheral nerve damage, spinal cord injury, neuropathic pain, and heart failure. For more information, please visit the Company’s website at: www.acorda.com.
SOURCE: Acorda Therapeutics
Post Views: 93
AC105 improved motor function after spinal cord injury in preclinical studies
ARDSLEY, NY, USA I September 25, 2013 I Acorda Therapeutics, Inc. (ACOR) today announced that the first patient has been enrolled in a trial of AC105, its proprietary magnesium formulation for the treatment of spinal cord injury (SCI). This Phase 2 trial will evaluate the safety and tolerability of the drug in people with traumatic SCI, and also incorporates several exploratory efficacy measures.
“In preclinical studies, AC105 improved motor function in SCI when therapy was initiated within a few hours after injury,” said Andrew R. Blight, Ph.D., Acorda Therapeutics’ Chief Scientific Officer. “Spinal cord injuries often result in severe, lifelong disability, so we’re excited to explore the potential to improve outcomes for people who suffer these very serious injuries.”
Magnesium’s neuroprotective properties are well established in the laboratory; however, the tolerable dosage range in the clinic is relatively narrow, which has made it a challenge to develop a practical therapy. Preclinical research shows that AC105’s formulation helps deliver magnesium to the injury site within the CNS, thereby providing a protective effect, but without requiring higher levels in the blood, which might result in significant side effects.
The primary objective of this double-blind, randomized and placebo controlled study is to evaluate the safety and tolerability of AC105 in people who have suffered an SCI. The study also includes several exploratory efficacy measures, including standard scales used to assess motor function. Participants in the trial will receive six intravenous doses of AC105 or placebo over 30 hours; the first dose to be administered within 12 hours of the injury.
The U.S. Food and Drug Administration (FDA) granted Fast Track designation for AC105 to improve functional recovery following acute SCI. The Company received a $2.67 million research contract from the U.S. Army Medical Research and Material Command to support the study. Acorda may potentially expand its AC105 program into other neurological injury indications.
Additional details on this clinical study, including enrollment criteria, can be found at: http://www.clinicaltrials.gov/ct2/show/NCT01750684
About Spinal Cord Injury
Spinal cord injury (SCI) is usually 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 between 183,000 and 230,000 people in the United States, and approximately 2 million people worldwide living with a spinal cord injury. Each year, there are approximately 11,000 new injuries reported in the United States. Males account for the majority of spinal cord injury patients with 50-70% of those occurring in those aged 15-35.
The costs of living with SCI can be considerable and can vary greatly due to the severity of injury. Long-term complications from SCI can include neurologic impairments resulting in paralysis, loss of sensation and disruption of any body system controlled by nerves originating at or below the area of the injury. Average annual medical cost for an SCI patient is $15,000-30,000 per year and the annual direct and indirect costs of SCI are estimated at $9.7 billion in the U.S. alone. There are currently no FDA-approved therapies indicated to treat, mitigate, or reverse SCI.
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a biotechnology company focused on developing therapies that restore function and improve the lives of people with neurological conditions.
Acorda markets three FDA-approved therapies including: AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg, a treatment to improve walking in patients with multiple sclerosis (MS); ZANAFLEX CAPSULES® (tizanidine hydrochloride) and Zanaflex tablets, a short-acting drug for the management of spasticity; and QUTENZA® (capsaicin) 8% Patch, for the management of neuropathic pain associated with postherpetic neuralgia. AMPYRA is marketed outside the United States as FAMPYRA® (prolonged-release fampridine tablets) by Biogen Idec under a licensing agreement from Acorda.
Acorda has one of the leading pipelines in the industry of novel neurological therapies. The Company is currently developing six clinical-stage therapies and one preclinical stage therapy that address a range of disorders including post-stroke deficits, epilepsy, cerebral palsy, stroke, peripheral nerve damage, spinal cord injury, neuropathic pain, and heart failure. For more information, please visit the Company’s website at: www.acorda.com.
SOURCE: Acorda Therapeutics
Post Views: 93
