Alseres pharmaceuticals concludes enrollment in the Cethrin phase I/IIa clinical trial in acute spinal cord injuryAlseres
Pharmaceuticals, Inc., announced that it has concluded enrollment in
the Phase I/IIa clinical trial of Cethrin in acute spinal cord injury
(SCI). A total of 48 subjects have been enrolled at 9 sites in the
United States and Canada. We expect to release periodic updates of the
data in 2008 following protocol-specified patient evaluations.
"We
continue to be encouraged by the safety and efficacy observations of
the trial. The rate and magnitude of improvement of many subjects seems
greater than the expected pattern of recovery," commented Dr. Mark
Hurtt, Alseres Chief Medical Officer. "The findings of the Phase I/IIa
study serve as a strong foundation for the acceleration of our
development plans for Cethrin."
Alseres intends to move forward
with its previously announced plans for the placebo-controlled, Cethrin
Phase IIb trial in acute spinal cord injury at sites in the U.S.,
Canada, Europe and other countries in 2008. "We believe that Cethrin
continues to be the most advanced drug candidate in the clinic for the
treatment of acute spinal cord injury in the world. If approved,
Cethrin may offer hope for the nearly 11,000 new cases annually in the
U.S. alone whose healthcare costs in the first year post-injury exceed
$4 Billion," noted Dr. Mark Pykett, President and COO of Alseres. "We
are pleased that the enrollment of the Phase I/IIa trial has concluded.
Interim reported data have demonstrated encouraging safety and efficacy
results over a 30-fold dose range. We look forward to the initiation of
the Phase IIb trial in the first half of 2008."
Cethrin contains
a proprietary protein that inactivates the action of Rho, a key enzyme
that prevents Axon Regeneration and recovery after SCI. It has been
granted Orphan Drug Status in the U.S. In February 2005, enrollment
began in an open-label, non-placebo-controlled, dose-escalating Phase
I/IIa trial in subjects with acute SCI at sites in the United States
and Canada. The trial assessed 5 dose levels of Cethrin from 0.3 mg to
9 mg in both Thoracic and Cervical injuries.
The trial design
includes a number of post-treatment evaluations of the subjects for
safety and efficacy for up to one year after treatment. The efficacy
measurements assess changes in subjects' sensory and Motor functions,
as well as overall recovery as measured by the American Spinal Injury
Association, or ASIA, Impairment Scale. The ASIA Impairment Scale is
used to score subjects within five categories from A to E, with A being
complete impairment with no sensory or motor function below the site of
injury and E being normal. Grades B through E designate increasing
levels of motor and sensory function. The subjects in the Cethrin Phase
I/IIa trial suffered a complete thoracic or cervical SCI and were thus
classified as an A on the ASIA Impairment Scale at the time of
enrollment in the trial.
The 6-month interim data on 37 of these
subjects treated with doses of up to 6 mg indicate that 27% of the
Cethrin treated subjects improved from ASIA A to ASIA B or better. This
is more than 400% greater than the conversion rate seen with the
standard of care in a similarly designed study reported by Burns and
colleagues in the Journal of Neurotrauma. When subjects with cervical
injuries who were treated with Cethrin were analyzed separately, about
46% of the subjects exhibited a conversion rate from ASIA A to ASIA B
or better. Moreover, about 18% of subjects overall and 38% of subjects
with cervical injuries improved to ASIA C or better over the six months
the hallmark of which is recovery of some motor function. In subjects
with cervical injuries, the interim efficacy data also suggest that the
response rate observed is dose-dependent at the doses up to 6 mg.
To
date, the safety and tolerability data for dose levels up to 6 mg
indicate that Cethrin appears to be safe and well tolerated. There have
been no serious adverse events related to Cethrin as determined by the
investigators and the independent Data Safety Monitoring Board, or
DSMB. There were two deaths of subjects enrolled in the trial. The DSMB
and the clinical investigators attributed the two deaths to causes
related to the subjects' initial Spinal Cord Injury, other injuries, or
preexisting conditions and not related to Cethrin.
About Alseres Pharmaceuticals, Inc.
Alseres
Pharmaceuticals, Inc. (Nasdaq: ALSE) is a Biotechnology company engaged
in developing breakthrough regenerative therapeutics to treat traumatic
injuries and degenerative diseases. The Company maintains a world-
class intellectual property position in the field of regenerative
therapeutics. The Company's energy and focus is reflected in several
important initiatives. Cethrin(R), a recombinant-protein-based drug
designed to promote nerve repair after acute spinal cord injury,
demonstrated positive interim results in a Phase I/IIa clinical trial.
The Company's research and pre-clinical programs include, Inosine for
the treatment of spinal cord injury and stroke, Oncomodulin for the
treatment of ocular injury and disease and research programs directed
at a number of regenerative therapies including bone repair. The
Company has a robust molecular imaging development program targeting
diagnosis of Parkinson's disease and potentially dementia and ADHD. The
Company's lead molecular imaging product candidate is ALTROPANE(R)
which is in Phase III clinical trials for the diagnosis of Parkinsonian
Syndromes including Parkinson's Disease. The Company has research
collaborations with Harvard Medical School and Children's Hospital
Boston.
Forward-looking statements
The
foregoing release contains certain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995.
Forward- looking statements include statements regarding Alseres
Pharmaceuticals' future expectations, beliefs, intentions, goals,
strategies, plans or prospects regarding the future, including the
Company's clinical development and trials for CETHRIN, the prospects of
FDA approval of CETHRIN and the commercialization, including partnering
opportunities, of CETHRIN. Forward- looking statements can be
identified by terminology such as "anticipate," "believe," "could,"
"could increase the likelihood," "estimate," "expect," "intend," "is
planned," "may," "should," "will," "will enable," "would be expected,"
"look forward," "may provide," "would" or similar terms, variations of
such terms or the negative of those terms. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors including those risks, uncertainties and factors referred to in
the Company's Quarterly Report on Form 10-Q for the quarter ended
September 30, 2007 filed with the Securities and Exchange Commission
under the section "Risk Factors," as well as other documents that may
be filed by Alseres Pharmaceuticals from time to time with the
Securities and Exchange Commission. As a result of such risks,
uncertainties and factors, the Company's actual results may differ
materially from any future results, performance or achievements
discussed in or implied by the forward-looking statements contained
herein. Alseres Pharmaceuticals is providing the information in this
press release as of this date and assumes no obligations to update the
information in this press release.
©2008 Alseres Pharmaceuticals, Inc.
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