Stem Cell Therapeutics Corp.

Stem Cell Therapeutics Corp.

July 27, 2009 08:30 ET

Stem Cell Therapeutics Corp. Provides Corporate Update

CALGARY, ALBERTA--(Marketwire - July 27, 2009) - Stem Cell Therapeutics Corp. ("SCT" or the "Company") (TSX VENTURE:SSS) announces today an update on key corporate developments and strategies.

"As announced throughout the past few months, we now have full regulatory approval to proceed with the modified REGENESIS Phase IIb stroke trial in the U.S., Canada and India. The Company is in the process of recruiting patients in these jurisdictions placing the trial in an excellent position to complete recruitment by the end of calendar year 2009, and have top-line data available by the end of Q1 09," stated Dr. Alan Moore, President and CEO. "Our confidence in the effect of the NTx®-265 regimen on acute ischemic stroke has been elevated further given the results of a recent meta-analysis of available clinical data".

SCT conducted a meta-analysis of the combined BETAS Phase IIa clinical stroke trial data and REGENESIS Phase IIb clinical stroke trial data. At the time the clinical hold was placed on the REGENESIS Phase IIb trial, seven patients had been recruited, and subsequently they completed their 90-day evaluation period. Because this trial was placebo controlled, patients received either placebo or NTx®-265 and so could be combined with patient data from the non-placebo controlled BETAS Phase IIa trial where patients only received NTx®-265. By performing this type of statistical analysis, the Company was able to compare the combined data from 19 patients: 14 of which received drug (12 from BETAS Phase IIa and 2 from REGENESIS Phase IIb) and 5 patients who received placebo (all from REGENESIS Phase IIb). A decrease in the National Institute of Health Stroke Score ("NIHSS") represents an improvement in a patient's functionality, and importantly for a recovering patient, a decrease of 4 units in the NIHSS scale is considered a clinically relevant improvement. Of the 5 patients who received placebo, the average NIHSS actually increased by +0.7 points and out of the 14 patients who received NTx®-265, the NIHSS decreased by 8.1 points. The p-value from this meta-analysis was greater than 0.0001, statistically significant.

For both the BETAS Phase IIa trial and REGENESIS Phase IIb trial, a patient that showed a decrease of 4 NIHSS points or greater was considered a responder. Hence the meta-analysis, when expressed as percentage responders, stated that the placebo group showed a 40% response (2 out of 5) whereas the NTx®-265 treated group showed a 100% response (14 out of 14) resulting in a p-value of p greater than 0.01, again statistically significant. The diagram below summarizes the improvement of patients in both the placebo group and NTx®-265 treated group.

To view the bar graph associated with this press release, please visit the following link:

"In parallel with re-initiating the Phase IIb stroke trial, we continue to work on two additional programs, traumatic brain injury ("TBI") and multiple sclerosis ("MS"), both of which should also reach clinical milestones towards the second half of this calendar year. We will provide updates on the progress of these efforts as they reach fruition during the next few months," stated Dr. Alan Moore, President and CEO. "Concurrently, we are also in discussions with potential partners for all programs."

As previously announced on July 8, 2009, SCT has offered an early warrant exercise incentive program (the "Program") designed to encourage the early exercise of up to 17,250,000 outstanding share purchase warrants (the "Warrants") for gross proceeds of up to $2,760,000. The Program is open for a 30 day period which ends on August 7, 2009. The Program is applicable only to holders of warrants issued in connection with the Company's financing completed on November 9, 2007. The warrants have an original exercise price of $0.50 per Warrant and expire on May 9, 2010. Holders of Warrants may exercise their Warrants at a temporarily discounted price of $0.16 per Warrant during the Early Warrant Exercise Period. Following the early Warrant Exercise Period, the outstanding Warrants will revert back to being exercisable to acquire common shares of the Company at a price of $0.50 per share.

The Company's current cash position is sufficient to complete all planned milestones including the modified REGENESIS Phase IIb clinical stroke trial. This is, in part, a result of cost cutting initiatives that include, but are not limited to, a reduction in executive salaries (as announced February 9, 2009).

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 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.

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.

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