Acorda Therapeutics, Inc. (Nasdaq: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.
Forward-Looking Statements
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. All
statements, other than statements of historical facts, regarding
management's expectations, beliefs, goals, plans or prospects should be
considered forward-looking. These statements are subject to risks and
uncertainties that could cause actual results to differ materially,
including our ability to successfully market and sell Ampyra in the
U.S.; third party payers (including governmental agencies) may not
reimburse for the use of Ampyra or our other products at acceptable
rates or at all and may impose restrictive prior authorization
requirements that limit or block prescriptions; the risk of unfavorable
results from future studies of Ampyra or from our other research and
development programs, including Diazepam Nasal Spray or any other
acquired or in-licensed programs; we may not be able to complete
development of, obtain regulatory approval for, or successfully market
Diazepam Nasal Spray or other products under development; the occurrence
of adverse safety events with our products; delays in obtaining or
failure to obtain regulatory approval of or to successfully market
Fampyra outside of the U.S. and our dependence on our collaboration
partner Biogen Idec in connection therewith; competition, including the
impact of generic competition on Zanaflex Capsules revenues; failure to
protect our intellectual property, to defend against the intellectual
property claims of others or to obtain third party intellectual property
licenses needed for the commercialization of our products; failure to
comply with regulatory requirements could result in adverse action by
regulatory agencies; and the ability to obtain additional financing to
support our operations. These and other risks are described in greater
detail in Acorda Therapeutics' filings with the Securities & Exchange
Commission. Acorda may not actually achieve the goals or plans described
in its forward-looking statements, and investors should not place undue
reliance on these statements. Forward-looking statements made in this
release are made only as of the date hereof, and Acorda disclaims any
intent or obligation to update any forward-looking statements as a
result of developments occurring after the date of this release.
Copyright Business Wire 2013