Results show promising neurological recovery in severely-injured, acute cervical spinal cord injury patients treated with Cethrin HOPKINTON, Mass., May 12
HOPKINTON, Mass., May 12 /PRNewswire-FirstCall/ -- Alseres
Pharmaceuticals, Inc. (Nasdaq: ALSE) today announced 12-month interim data
from its Phase I/IIa clinical trial of Cethrin, a proprietary recombinant
protein that is being investigated for its potential to restore motor and
sensory function after spinal cord injury, or SCI. The trial enrolled a total
of 48 patients of which 37 have reached the final 12 month follow up
evaluation. The data for these first 37 patients indicate that at 6 and 12
months after treatment, 38% (5 of 13) of cervical injury patients showed
marked recovery of motor and sensory function after treatment as measured by a
2-grade or better improvement in the American Spinal Injury Association, or
ASIA, Impairment Scale. Analysis of the data by dose group indicates that
Cethrin doses of 1 and 3 mg appear to be the most beneficial for cervical
patients with 43% (3 of 7) showing the same 2-grade or better recovery of
motor and sensory function.
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"The safety and efficacy observations of the Cethrin trial continue to be
encouraging. Many patients have shown a degree of improvement far above the
expected outcome," commented Dr. Mark Hurtt, Alseres' Chief Medical Officer.
"The interim results of the Phase I/IIa study have helped identify what we
believe will be the most effective dose range to carry into our Phase IIb
trial later this year."
Based on these results, Alseres intends to move forward with its
previously announced plans for the Cethrin Phase IIb trial in acute spinal
cord injury in the second half of 2008. This trial will be a double-blind,
randomized, placebo-controlled, multi-center, Phase IIb trial in up to 100
patients with acute cervical SCI at up to 80 sites in the United States,
Canada, Europe and other selected countries.
A total of 48 patients with acute SCI were enrolled in the Phase I/IIa
open label study at nine sites across Canada and the United States. An
escalating dose of Cethrin (0.3, 1, 3, 6 or 9 mg) was administered to the
injured spinal cord during spinal decompression surgery. Neurological
outcomes were measured using the ASIA Impairment Scale, or AIS. Evaluations
were completed at 0, 1.5, 3, 6 and 12 months after treatment. Only patients
who suffered a complete thoracic or cervical SCI (classified as grade A on the
ASIA Impairment Scale) were enrolled in the trial.
The ASIA Impairment Scale is used to grade patients 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. Patients
classified as AIS C have regained sensory and partial motor function and those
classified as D often regain the ability to walk with assistance. A component
of this scale is the assessment of change in Motor Score. The measurement is
made by assessing five muscle groups in each arm and leg on a 0-5 point scale
for a total of 100 motor points. Using this assessment, the total change in
motor function can be measured. The Clinical Guidelines Panel Report issued
by the International Campaign for Cures of spinal cord injury Paralysis, or
ICCP, indicates that a cervical, AIS A-injured patient is likely to improve 10
ASIA motor points during the first year after SCI.
The following outcomes were demonstrated in the 12-month interim data on
the first 37 acute spinal cord injury patients who received doses up to 6 mg:
-- There were no serious adverse events related to Cethrin.
-- The data from 6 and 12 months showed 38% (5 of 13) of cervical injury
patients showed a 2-grade or better AIS grade improvement.
-- Subgroup analysis appears to indicate a dose related response in the
cervical patient group with 43% (3 of 7) of the cervical patients from
the 1 and 3 mg dose groups demonstrating improvement of at least 2 AIS
grades. Two of these three patients improved 3 levels from AIS grade A
to AIS grade D.
-- Subgroup analysis of 12-month mean motor score changes showed
improvement in both the 1 and 3 mg dosage groups in the
cervical-injured patients with mean motor score changes of 16.3 points
in the 1 mg and 27.3 points in the 3 mg doses.
-- Analysis of individual dose groups over time using both ASIA Impairment
Scale grade and ASIA Motor Score changes suggest that the most
effective Cethrin doses are 1 and 3 mg for cervical patients.
Patients in the cervical and thoracic 9 mg dose cohort are still being
assessed and their data will be reported when it is available.
About Cethrin(R)
Cethrin is a recombinant protein drug that is being investigated for its
potential to restore motor and sensory function after spinal cord injury.
Following an SCI, about two-thirds of patients undergo
decompression/stabilization surgery. During surgery, Cethrin is delivered by
a single application to the injured region of the spinal cord. Cethrin has
been designated as an Orphan Drug by the FDA.
About Alseres Pharmaceuticals, Inc.
Alseres Pharmaceuticals, Inc. (ALSE) is engaged in the development of
therapeutic and diagnostic products primarily for disorders in the central
nervous system (CNS). 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, 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. The Company's lead molecular
imaging product candidate is Altropane 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' future expectations,
beliefs, intentions, goals, strategies, plans or prospects regarding the
future, including the development and commercialization of Altropane and
Cethrin, the prospects of the Company's CNS and regenerative therapeutics
programs, the Company's strategies to develop and commercialize axon
regeneration technologies and the breadth of the Company's technologies and
intellectual property portfolio. 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 Annual Report on Form 10-K for the year
ended December 31, 2007 filed with the Securities and Exchange Commission
under the section "Risk Factors," as well as other documents that may be filed
by Alseres 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 is providing the information in this press release
as of this date and assumes no obligations to update the information in this
press release.
Alseres is a trademark and Cethrin and Altropane are registered trademarks
of Alseres Pharmaceuticals, Inc.
Contact:
Sharon Correia -- 508-497-2360 ext. 224
Alseres Pharmaceuticals, Inc.
scorreia@alseres.com
Adam Friedman -- 212-981-2529 ext. 18
Adam Friedman Associates
adam@adam-friedman.com
http://www.alseres.com
SOURCE Alseres Pharmaceuticals, Inc.
