CALGARY, ALBERTA--(Marketwire - February 09, 2009) - Stem Cell Therapeutics Corp. (the “Company” or “SCT”) (TSX VENTURE: SSS) announces today an update on key corporate developments and strategies.
The Company is actively pursuing the removal of the clinical hold through ongoing discussions with the U.S. Food and Drug Administration (“FDA”), but as yet, no formal notice has been received to lift the clinical hold on its Phase IIb REGENESIS stroke trial. The Company has therefore decided to investigate alternate stroke regimen options from within its patent portfolio that do not involve erythropoietin (“EPO”), as the Company believes it is the use of EPO as part of its stroke treatment that gave rise to the clinical hold. These alternate regimens will continue to follow the same therapeutic approach whereby adult stem cells are stimulated to proliferate and differentiate into neurons to replace damaged brain tissue. The Company expects to be in a position to assess the viability of pursuing other options in the second quarter of this year.
Dr. Alan Moore, President and CEO of SCT, commented as follows:
“In addition to continuing to work with the FDA in an effort to lift the clinical hold, we feel that it is in the best interests of the Company to explore alternatives to EPO in the event that the FDA determines the clinical hold cannot be lifted within a reasonable timeframe.”
Currently, the Company has in excess of C$6.0M cash on hand which is sufficient to maintain operations for 2009 and to complete all planned milestones, including the REGENISIS study. This is, in part, a result of recent cost cutting initiatives that include, but are not limited to, a reduction in executive salaries in return for a commitment with respect to the future issuance of stock options.
SCT will continue to provide updates as key developments occur.
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 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.
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
The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.
Contacts:
Stem Cell Therapeutics Corp.
Alan Moore, PhD
President and CEO
(403) 245-5495 ext. 224
Email: amoore@stemcellthera.com
Stem Cell Therapeutics Corp.
Chloe Douglas-Crampton
Investor Relations
(403) 245-5495 ext. 221
Email: crampton@stemcellthera.com
Website: www.stemcellthera.com