CALGARY, Jan. 20 /PRNewswire-FirstCall/ - Stem Cell Therapeutics Corp. (“SCT”) today announced selected upcoming development milestones that include commencement of two Phase II human clinical trials to evaluate the company’s lead therapy, NTx(TM)-265, as a treatment for stroke. In addition, SCT has made an updated presentation and fact sheet available on its website.
Dr. Joseph Tucker, SCT’s President and Chief Executive Officer, said the company’s upcoming milestones are based on its recent achievements. Selected recent achievements include:
- Completed an Initial Public Offering, raising gross proceeds of $8.5M; - Demonstrated functional recovery of animals with experimental stroke; - Identified the lead therapeutic regimen, NTx(TM)-265; - Initiated discussions with potential development partners; and - Initiated and completed dosing of a Phase I clinical study.
“Each year there are approximately 15 million people worldwide that suffer a stroke, many of whom require an effective treatment to promote functional recovery following that stroke. SCT continues to focus its efforts toward developing drugs that will address this major unmet medical need,” Dr. Tucker said. “Our team has excelled at successfully meeting or exceeding milestones and we will remain focused on continuing this pace and course of action.”
SCT’s therapeutic approach has shown efficacy in animal models of central nervous system disorders, including stroke. SCT is taking advantage of these novel findings with a strategy to rapidly proceed with clinical development in diseases where there are significant market opportunities and unmet medical needs.
Some selected upcoming milestones for SCT are: - Animal studies validating proposed clinical regimen with lead therapy: NTx(TM)-265; - Release Phase I clinical trial results; - Initiate NTx(TM)-265 Phase IIa single site, open label safety study in approximately Q1, 2006; - Initiate NTx(TM)-265 Phase IIb multi-site, proof of concept study with anticipated completion in Q2, 2008; and - Initiate development of second program;
As well, SCT is pleased to announce that an updated presentation and fact sheet are now available on its website at www.stemcellthera.com.
Stroke, which is the third leading cause of death in the United States and second worldwide, has an incidence of 700,000 victims in the U.S. each year. The American Heart Association estimated the economic costs in the US at $56.8B for 2005. Because of the lack of effective therapies currently available it is estimated that approximately 4% of stroke patients are treated with interventional drugs.
About Stem Cell Therapeutics Corp.: SCT is a biotechnology company focused on the development of its technology platform and intellectual property to selectively induce a patient’s own stem cells to proliferate in the brain. SCT’s core technology, which includes its lead therapeutic product NTx(TM)-265, has been demonstrated to increase the number of innate adult stem cells that grow in place when this therapeutic approach is applied to test animals. SCT plans to develop this fundamental technology further for specific disease treatments such as stroke, and potentially Huntington’s disease, Alzheimer’s disease and other neurodegenerative conditions.
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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.
Stem Cell Therapeutics Corp.
CONTACT: For more information on Stem Cell Therapeutics Corp., visitwww.stemcellthera.com or contact: Dr. Joseph Tucker, Chief ExecutiveOfficer, Stem Cell Therapeutics Corp., Phone: (403) 245-5495,info@stemcellthera.com
