Stem Cell Therapeutics Announces Favorable Results From the Phase IIa BETAS Stroke Trial
February 20 2008 - 10:32AM
Marketwired
CALGARY, ALBERTA (TSX VENTURE: SSS) is pleased to announce
favorable results from the investigator led BETAS (Beta-hCG +
Erythropoietin in Acute Stroke), Phase IIa, open label, safety
trial conducted at the University of California, Irvine and Hoag
Presbyterian Memorial Hospital, Newport Beach, CA. This trial is
the first to test the safety of NTx(TM)-265 in patients suffering
acute ischemic stroke and to conduct a preliminary assessment of
functional recovery in this patient population.
Results from the BETAS trial showed no serious adverse events
related to NTx(TM)-265 in the 13 patients enrolled. Of these, 8
patients completed the 90 day assessment term and each of them
showed a clinically relevant improvement in their National
Institutes of Health Stroke Scale (NIHSS) score of 4 points or
greater. Patients entered the trial with NIHSS scores ranging from
6-19 (moderate to severe). In these patients, average baseline
NIHSS was 8.3 plus/minus 4.1 (mean plus/minus SD) and improved in 8
of 8 patients to an average day 90 NIHSS of 2.5 plus/minus 1.8, an
improvement in NIHSS score of 5.8 plus/minus 2.5 points. Five of
these 8 patients had a day 90 Barthel Index score of 95-100 (out of
100); consistent with excellent outcome. Specific assessments of
neurological recovery affected by NTx(TM)-265 were also favorable,
including the Arm Motor Fugl-Meyer Scale, an arm motor recovery
assessment; Trailmaking A test, a measure of cognitive function;
and measures of neglect and aphasia. Further, the drug regimen
decreased the size of the infarct in 6 out of 8 patients overall,
given a mean decrement in all 8 of about 10%.
Dr. Alan Moore, President and CEO of SCT, commented as
follows:
"The encouraging results from this trial are consistent with
results previously reported as an interim analysis on April 10,
2007 and suggest great promise for our NTx(TM)-265 treatment for
stroke, but interpretation of results from the BETAS trial is
limited by small patient sample size and absence of a placebo
control group. Nevertheless, these results represent an important
first step in defining the safety of the NTx(TM)-265 regimen in
patients with acute neurologic injury. Equally promising is early
evidence in a small group of patients that consistent recovery of
motor, cognitive and visual function may occur as a result of
NTx(TM)-265 neuro-regenerative therapy for stroke."
The next development step for SCT is to build upon the promising
results from the BETAS clinical trial with the initiation of the
REGENESIS proof of concept study. REGENESIS is a Phase IIb
prospective, randomized, double-blind, placebo controlled study of
NTx(TM)-265: human Chorionic Gonadotropin (hCG) and epoetin alfa
(EPO) in acute ischemic stroke patients. The REGENESIS trial will
be conducted at approximately 15-20 Canadian clinical trial centers
and aims to enroll 134 patients in 2008.
The BETAS clinical data will be formally presented at the
International Stroke Conference in New Orleans, LA, February 20-22,
2008. SCT will also be hosting a live audio webcast to review the
results with Dr. Steven Cramer on Tuesday February 26, 2008.
Stem Cell Therapeutics Conference Call
SCT will be hosting a live audio webcast on Tuesday, February
26, 2008 at 1:00 PM EST to review the BETAS Phase IIa results with
Dr. Steven Cramer. Participants may listen via audio webcast,
accessible through the Company's website at www.stemcellthera.com
or via telephone. The telephone conference number is 416-849-2698
or toll-free at 1-866-400-2270.
About NTx(TM)-265: NTx(TM)-265 is a therapeutic regimen of two
approved and clinically well-defined drugs, human Chorionic
Gonadotropin (hCG) and Erythropoietin (EPO), targeting the
treatment of stroke. The objective of the regimen is to stimulate
the growth and differentiation of new neurons to replace the brain
cells that were lost or damaged by the stroke. Animal studies have
shown a significant recovery in motor function after receiving the
NTx(TM)-265 regimen 24-48 hours post stroke. Similar results have
been found in SCT's Phase IIa BETAS safety trial, as announced on
April 10, 2007. SCT has initiated a multi-centre, double-blind,
placebo-controlled Phase IIb REGENESIS study for NTx(TM)-265 with
primary endpoints of efficacy.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp.
is a Canadian public biotechnology company (TSX VENTURE: SSS)
focused on the development and commercialization of drug-based
therapies to treat central nervous system diseases. SCT is a leader
in the development of therapies that utilize drugs to stimulate a
patient's own resident stem cells. The company's programs aim to
repair neurological function lost due to disease or injury. The
company's extensive patent portfolio of owned and licensed
intellectual property supports the potential expansion into future
clinical programs in numerous neurological diseases.
For further information on Stem Cell Therapeutics Corp., visit
www.stemcellthera.com.
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of any state, and may not be offered or sold within the United
States or to, or for the account or benefit of U.S. persons unless
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available.
Except for historical information, this press release may
contain forward-looking statements, which reflect the Company's
current expectation regarding future events. These forward-looking
statements involve risk and uncertainties, which may cause but are
not limited to, changing market conditions, the successful and
timely completion of clinical studies, the establishment of
corporate alliances, the impact of competitive products and
pricing, new product development, uncertainties related to the
regulatory approval process and other risks detailed from time to
time in the Company's ongoing quarterly and annual reporting.
The TSX Venture Exchange does not accept responsibility for the
adequacy or accuracy of this release.
Contacts: Stem Cell Therapeutics Corp. Alan Moore, PhD President
and CEO (403) 245-5495 ext.224 Email: amoore@stemcellthera.com Stem
Cell Therapeutics Corp. Chloe Douglas-Crampton Manager, Investor
Relations (403) 245-5495 ext. 221 Email: crampton@stemcellthera.com
Website: www.stemcellthera.com
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