Stem Cell Therapeutics Corp.
TSX VENTURE : SSS

Stem Cell Therapeutics Corp.

May 25, 2010 07:00 ET

Stem Cell Therapeutics Corp. Announces Top-Line Results for the Modified REGENESIS Phase IIb Stroke Trial

CALGARY, ALBERTA--(Marketwire - May 25, 2010) - Stem Cell Therapeutics Corp. ("SCT" or the "Company") (TSX VENTURE:SSS) announced today the top-line results for the modified REGENESIS-Phase IIb stroke trial. The modified REGENESIS- Phase IIb trial, a placebo controlled, double blinded, 3:1 randomized clinical study, enrolled 96 patients with acute ischemic stroke between August 2009 and January 24, 2010. SCT reports that the top-line primary endpoint results for this Phase IIb clinical trial of NTx®-265 in acute stroke showed that there was substantial improvement in the primary endpoint absolute change in NIHSS in both placebo treated patients and those receiving NTx®-265 with no statistical differences between the groups.

"The profile and magnitude of the placebo response is extremely surprising and merits further examination" said Dr. Alan Moore, CEO and President of Stem Cell Therapeutics. "We are currently conducting a validation review process of the full trial. We expect to report on the outcome of this within the next 2-3 weeks, together with results from a number of secondary endpoints such as modified Rankin and Barthel index, which may provide an alternative to NIHSS as a pathway forwards."

The results show that NTx®-265 was well tolerated in treated patients with no adverse affect on mortality. Of the 96 patients enrolled in the trial, 72 patients were administered a course of NTx®-265, sequential administration of human chorionic gandotropin (hCG) followed by erythropoietin (EPO), with the first dose at 24-48 hours after stroke onset while 24 patients were treated with placebo. All patients were then monitored for 90 days. The top-line data show that the NTx®-265 treated group showed a drop of 6.3 ± 0.5 NIHSS compared to placebo drop of 7.3 ± 0.9 NIHSS. This difference was not statistically significant. Additionally, none of the individual dose groups showed a statistically significant effect compared to placebo.

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.

For further information on Stem Cell Therapeutics Corp., visit www.stemcellthera.com.

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.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact Information