Healthcare Industry News: Stem Cell Therapeutics Corp
News Release - July 21, 2009
Stem Cell Therapeutics Corp. Receives Green Light to Begin Enrolling Patients in the India Phase IIb Acute Ischemic Stroke TrialCALGARY, ALBERTA, Stem Cell Therapeutics Corp. --(HSMN NewsFeed)--("SCT" or the "Company") (TSX-V:SSS ) has received a No Objection Letter ("NOL") from the Drug Controller General of India ("DCGI") to initiate the Phase IIb acute ischemic stroke trial. This investigational new drug ("IND") opening study is a double-blind, randomized, placebo-controlled clinical trial of its lead program, NTx-265, for the treatment of acute ischemic stroke. The DCGI response allows initiation of the modified REGENESIS protocol for the Phase IIb clinical trial in acute ischemic stroke, which is co-Led by two principle investigators: Dr. Steven C. Cramer, from the University of California, Irvine and Dr. Michael D. Hill of Foothills Hospital at the University of Calgary.
The recruitment target for this study is to enroll 128-130 patients. The Indian, U.S., and Canadian protocols share similar design, as well as safety and efficacy endpoints.
Dr. Alan Moore, President and CEO, commented as follows:
"Approval from the DCGI to initiate recruitment for the modified REGENESIS stroke trial in India is an exciting milestone for SCT. Jurisdictional approvals have now been granted in India, U.S. and Canada therefore we will begin recruiting patients as soon as possible."
About the DCGI
Clinical trials are regulated by the Drug Controller General of India ("DCGI"), who is responsible for assuring that all clinical trials comply with the requirements of the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, as well as Good Clinical Practices. The DCGI approval process categorizes clinical trials into two types. If the study protocol has already been approved by a cognizant regulatory authority in one or more developed countries (such as the U.S., Canada, U.K., Switzerland, Germany, Australia, Japan, and South Africa), the study is classified as a Type A trial and can be approved using a fast-track process within two to six weeks after the required documentation has been submitted. All other studies are classified as Type B. For these, the approval process is generally 8 to 12 weeks. The Institutional Review Board ("IRB") approval process can be conducted in parallel with the DCGI review and, if import licenses are needed, the applications for these can also proceed in parallel. These provisions facilitate the process of getting study protocols in place and quickly initiating the trials.
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 regimen 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 functional recovery of motor, visual and cognitive capacity after acute ischemic stroke. Animal studies have shown a significant recovery in motor function after receiving the NTx-265 regimen 24-48 hours post stroke. Encouraging final clinical results from SCT's completed 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 regimen. SCT will soon begin recruiting patients for the multi-centre, double-blind, placebo-controlled Phase IIb stroke study for NTx-265 with primary endpoints of efficacy and safety.
About Stem Cell Therapeutics Corp.
Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (TSX-V: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 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.
Source: Stem Cell Therapeutics Corp
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