News Release - Full TextStem Cell Therapeutics Corp. Announces Completion of Further Analysis of the Modified REGENESIS Stroke Data
Further Analysis of NTX-265 REGENESIS Stroke Trial Data Provides Encouraging Information for Further Evaluation
CALGARY, ALBERTA, Sep 09, 2010 (MARKETWIRE via COMTEX News Network) --
Stem Cell Therapeutics Corp. ("SCT" or the "Company") (TSX VENTURE: SSS) wishes to announce that further analyses of the modified REGENESIS stroke data base have been completed. First, no dose-related treatment mortality was seen, confirming our earlier observations. Second, in those patients who received occupational therapy (OT) - approximately 25% of the total - the NTx(R)-265 regimen had a statistically significant beneficial effect on the National Institute of Health Stroke Score ("NIHSS", the defined primary endpoint in the study), showing a mean reduction of 5.1 points for placebo vs. 8.6 points for NTx(R)-265 therapy. Additionally, in this subgroup, the effect of NTx(R)-265 was also statistically significant versus placebo on the secondary endpoint of modified Rankin and trended in favor of NTx(R)-265 for geriatric depression score, an important measure of "well being" in post-stroke patients.
Separately, in an analysis of the approximately 69% of patients who had one observer throughout the study versus multiple observers, all endpoints, primary and secondary, were in favor of the NTx(R)-265 regimen, although the effects were not as dramatic as that seen in the OT subgroup, and were not statistically significant. In the much smaller subgroup that combined criteria, OT plus a single observer, separation of drug and placebo effect was even more dramatic for NIHSS. Specifically, the NTx(R)-265 regimen reduced the NIHSS by a mean of 9.1 points whereas the placebo mean response was only 3.3 points, and again this difference was statistically significant.
Dr. Alan Moore, President & CEO of SCT stated "While these subgroup analyses were not pre-specified, they provide key information going forward with clinical evaluation of the NTx(R)-265 regimen, and in discussions with the FDA, on the importance of OT and one versus multiple assessors. Further, the OT findings appear to confirm the original mechanistic understanding of the NTx(R)-265 regimen - that it works by amplifying a natural process, the restructuring of neural functioning post stroke"
As stated previously, the Company continues to move forward as a biotech company considering a range of options, with management focusing its efforts on pursuing the end-of-Phase II meeting with the FDA for the NTx(R)-265 stroke therapy while concurrently reviewing alternatives for pursuing the traumatic brain injury ("TBI") and multiple sclerosis ("MS") study opportunities, as well as various external opportunities.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a 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 brain and nerve 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 such as traumatic brain injury, multiple sclerosis, Huntington's disease, Alzheimer's disease, and ALS.
These securities have not been registered under the United States Securities Act of 1933, as amended, or the securities laws 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 an applicable exemption from U.S. registration requirements is 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.
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Contacts: Stem Cell Therapeutics Corp. Alan Moore, PhD President and CEO 403-245-5495 ext.224 amoore@stemcellthera.com Stem Cell Therapeutics Corp. Angelika Goncalves DaSilva Operations Manager 403-245-5495 ext. 221 adasilva@stemcellthera.com www.stemcellthera.com
SOURCE: Stem Cell Therapeutics Corp.
mailto:amoore@stemcellthera.com mailto:adasilva@stemcellthera.com https://www.stemcellthera.com
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