CALGARY, ALBERTA--(Marketwire - December 22, 2010) - Stem Cell Therapeutics Corp. (TSX VENTURE: SSS) ("SCT" or the "Company") announced today that on Monday Dec 20, 2010 SCT met with the U.S. Food and Drug Administration ("FDA") and participated in an End of Phase 2 (EOP2) meeting. The outcome of the meeting discussion clarified the regulatory path forward for the NTx®-265 program, regarding minimum steps necessary to submit a marketing application for NTx®-265 in acute ischemic stroke. The next steps for SCT are to design a path forward to advance the NTx®-265 program, based on the valuable information gained from the REGENESIS-LED trial and this FDA meeting.
Discussions between SCT and FDA included a review of safety and exploratory efficacy data accumulated during phase 2 trials: BETAS, REGENESIS and REGENESIS-LED. Further discussion focused on the path of development for NTx®-265 and included potential pivotal trial designs, efficacy endpoints and statistical analysis options. SCT expects to receive the official FDA minutes of the meeting in the New Year. After the FDA minutes are received, SCT will determine the most strategic path forward for the NTx®-265 program, then work to implement that plan. Further detailed announcements are anticipated after that date.
The purpose of this type of meeting is to assess the project's data to date and to discuss parameters for proceeding to pivotal studies (Phase 3). Meeting discussion evaluates FDA's view of the future clinical plan, including protocol design details and the adequacy of current studies to support the future studies. An EOP2 meeting is also useful to identify any additional information FDA thinks necessary to support a marketing application for the uses under investigation.
SCT's was pleased with the positive and constructive outcome of this meeting.
During 2010 SCT has undergone considerable changes, including re-evaluation of programs and company structure. As a result of the changes the company has emerged revitalized with a strong focus on building a business aimed at translating the company's broad intellectual property portfolio into business opportunities and strategic alliances.
SCT's revitalized focus for 2011-2012 is to direct carefully managed finances, personnel and time toward the following programs and creating value for our various stakeholders.
The following are general timelines for key milestones of SCT's three clinical programs:
-- Q1, 2011 - Receive FDA minutes from End of Phase 2 meeting
-- H1, 2011 - Plan and initiate the next stroke study
-- H2, 2011 - Initiate enrollment in Stroke Study
-- Q1, 2012 - Optional interim analysis of Stroke Study
-- Q4, 2012 - Complete Enrollment in Stroke Study
Traumatic Brain Injury (TBI):
-- Q1, 2011 - Continue enrollment in Phase IIa Trial
-- Q4, 2011 - Report top line data
Multiple Sclerosis (MS):
-- H1, 2011 - Complete strategic analysis to advance this program.
An SCT-supported Investigator-Initiated study is currently enrolling patients in its 10 patient traumatic brain injury (TBI) Phase IIa trial. This trial is being conducted at Foothill Medical Center, Calgary Canada and is designed to characterize the safety of hCG and EPO in traumatic brain injury. SCT will update our stakeholders as this trial progresses.
The Company has received considerable support from its various stakeholders. SCT will start fiscal 2011 with approximately $2,865,000 in cash and cash equivalents. This capital has enabled SCT to advance program plans for future activities. As Fiscal 2011 opens, SCT will be working on the initiation, enrollment and completion of clinical trials, continuing to strategically evaluate programs and reviewing new opportunities. The company anticipates announcements regarding these activities throughout 2011.
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.
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.