a comparable historical study who did not receive CETHRIN. When
analyzed as a subset, patients with cervical (neck) injuries who were
treated with CETHRIN showed improvement using the same impairment scale
that was almost 700% greater than the full patient group treated with
only the standard of care reported in the comparable study. In
subjects with cervical injuries, the interim efficacy data also suggest
that the conversion rate was dose-dependent.
-- In April and June 2007, Health Canada and the U.S. Food and Drug
Administration (FDA), respectively, authorized enrollment at an
increased dose level (9mg) in the CETHRIN Phase I/IIa clinical trial.
-- In January 2008, we ended enrollment in the CETHRIN Phase I/IIa
clinical trial. In total, 48 patients were enrolled at nine sites in
the United States and Canada. The results of the trial will continue
to be analyzed and communicated as the post-treatment evaluations are
-- At the end of 2007 and in early 2008, the Company met with the FDA,
Health Canada and the European Medicines Agency (EMEA), to review the
Phase I/IIa results and our CETHRIN clinical development plan. Based
on these discussions, Alseres plans to initiate a double-blind,
randomized, placebo-controlled, multi-center Phase IIb trial in up to
200 subjects with acute cervical SCI at up to 80 sites in the United
States, Canada, Europe and other selected countries during the second
half of 2008.
Presented results at major scientific and medical meetings.
During 2007, the Company presented data from its clinical programs at a
number of peer-reviewed scientific and medical meetings including:
-- Canadian Spine, March 2007;
-- American Association of Neurolog
|SOURCE Alseres Pharmaceuticals, Inc.|
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