Stem Cell Therapeutics Corp.

Stem Cell Therapeutics Corp.

February 16, 2010 08:30 ET

Stem Cell Therapeutics Corp. Provides Update on Modified REGENESIS Phase IIb Stroke Trial

CALGARY, ALBERTA--(Marketwire - Feb. 16, 2010) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS) ("SCT" or the "Company") announced today that it will focus the remaining patient enrollment of the modified Phase IIb stroke trial in Canada and the U.S. and will no longer recruit patients from India. As standard practice, the Drug Controller General of India ("DCGI") limits the amount of patients that participate in clinical trials from companies that are not located in India and SCT has been advised that the stroke trial has reached its limit of recruiting patients from India. 

This decision by the DCGI was not based on any safety or mortality concerns. As announced, the Data Safety Monitoring Board ("DSMB") completed three safety analyses and recommended for the Phase IIb acute ischemic stroke trial to continue as per protocol after each analysis. 

Dr. Alan Moore, President and CEO, commented as follows:

"We have moved quickly through the modified REGENESIS Phase IIb stroke trial so far, having enrolled 96 patients in six months, and we will now be focusing our remaining patient recruitment efforts in Canada and the U.S. instead of India. Given our historic recruiting rate in North America, it now appears unlikely that we will able to complete the enrollment of 128 patients by the end of Q1 2010, as previously announced. We will also be reviewing alternate methods of data analysis to possibly allow an earlier study conclusion prior to recruiting the original goal of 128 patients. "

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

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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