CALGARY, ALBERTA--(MARKET WIRE)--May 21, 2009 -- Stem Cell Therapeutics Corp. (CDNX:SSS.V - News) (the "Company" or "SCT") is pleased to announce that as a result of the U.S. Food and Drug Administration ("FDA") lifting the Phase IIb clinical hold as announced on May 15, 2009, and encouraging results from the Phase IIb patients enrolled prior to the clinical hold, it has decided to commence the modified Phase IIb REGENESIS clinical stroke trial as soon as possible, with the goal of completing patient enrollment by the end of 2009.
Dr. Alan Moore, President and CEO of SCT, commented as follows:
"Before starting the modified REGENESIS Phase IIb study, we un-blinded results from the seven patients who were enrolled in the halted Phase IIb trial. Although these results are not statistically significant, due to the small number of patients, they are encouraging and consistent with the Phase IIa results announced in February of this year. We were also pleased to see that there were no adverse health effects among the patients who received the treatment, which is also consistent with our findings in the Phase IIa trial. All of this has reinforced our confidence in NTx®-265 and we are excited to proceed with the testing of our treatment for stroke patients."
The results of the Phase IIb trial from the seven patients indicated an improvement in the treated group as compared to the placebo group. This is demonstrated by the graph below; of the seven patients enrolled, five received placebo and two were treated with NTx®-265: A decrease in the NIHSS score represents an improvement in a patient's functionality. A change of 4 units in the NIHSS scale is considered clinically significant. The placebo patients score decreased by an average of 1.4 units, which did not attain this level of clinical significance. The treated patients, however, showed an average decrease of 9 units, exceeding the level for clinical significance.
To view a graph of the REGENESIS-Effect of NTx®-265 on NIHSS Score, please view the following link: http://media3.marketwire.com/docs/sssgraph0521s.pdf
The Company is also pleased to announce the following corporate developments:
- Mr. Robert W. Rieder, Chairman and CEO of Cardiome Pharma Corp. ("Cardiome") has been elected to SCT's Board of Directors. Mr. Rieder, an MBA, has been Chairman of Cardiome (formerly, Nortran Pharmaceuticals Inc.) since March 12, 2007 and has been its Chief Executive Officer since April 16, 1998. Mr. Rieder has extensive experience in venture capital and in operational management.
- Dr. W. Dalton Dietrich has joined SCT's Scientific Advisory Board. Dr. Dietrich is the Kinetic Concepts Distinguished Chair in Neurosurgery, Professor of Neurological Surgery, Neurology and Cell Biology and Anatomy, as well as the Scientific Director of the Miami Project to Cure Paralysis at the Miller School of Medicine.
Finally, the Company wishes to announce that Dr. Francesco Bellini of Bellus Health Inc., decided not to stand for re-election to the SCT's Board of Directors. The Company would like to thank Dr. Bellini for his contribution while serving on SCT's Board and to wish him well with his future endeavors.
SCT has issued 100,000 stock options to Mr. Rieder and 25,000 stock options to Dr. Dietrich at an exercise price of C$0.10 per share in connection with their appointments to the Company. These options will expire no later than May 20, 2014 subject to applicable vesting provisions. These options were awarded in accordance with the Corporations Stock Option Plan.
About REGENESIS: NTx®-265 is SCT's lead therapeutic regimen of two approved and clinically well-defined drugs, human Chorionic Gonadotropin ("hCG") and Erythropoietin ("EPO"), targeting the treatment of stroke. The twin objectives of the treatment are to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the stroke, and importantly, to direct motor, visual, and cognitive recovery after the acute ischemic stroke. Encouraging clinical results from SCT's BETAS Phase IIa stroke trial were presented at the International Stroke Conference in February 2009, showing clinically relevant recovery in 12 of 12 patients who received the complete treatment.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (CDNX:SSS.V - News) 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. SCT'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.
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Stem Cell Therapeutics Corp.
Alan Moore, PhD
President and CEO
(403) 245-5495 ext.224
Stem Cell Therapeutics Corp.
(403) 245-5495 ext. 221