Healthcare Industry News: Stem Cell Therapeutics Corp
News Release - February 20, 2008
Stem Cell Therapeutics Announces Favorable Results From the Phase IIa BETAS Stroke TrialCALGARY, ALBERTA--(Healthcare Sales & Marketing Network)--Feb 20, 2008 -- Stem Cell Therapeutics Corp. ("SCT") (CDNX:SSS.V ) is pleased to announce favorable results from the investigator led BETAS (Beta-hCG + Erythropoietin in Acute Stroke), Phase IIa, open label, safety trial conducted at the University of California, Irvine and Hoag Presbyterian Memorial Hospital, Newport Beach, CA. This trial is the first to test the safety of NTx(TM)-265 in patients suffering acute ischemic stroke and to conduct a preliminary assessment of functional recovery in this patient population.
Results from the BETAS trial showed no serious adverse events related to NTx(TM)-265 in the 13 patients enrolled. Of these, 8 patients completed the 90 day assessment term and each of them showed a clinically relevant improvement in their National Institutes of Health Stroke Scale (NIHSS) score of 4 points or greater. Patients entered the trial with NIHSS scores ranging from 6-19 (moderate to severe). In these patients, average baseline NIHSS was 8.3 plus/minus 4.1 (mean plus/minus SD) and improved in 8 of 8 patients to an average day 90 NIHSS of 2.5 plus/minus 1.8, an improvement in NIHSS score of 5.8 plus/minus 2.5 points. Five of these 8 patients had a day 90 Barthel Index score of 95-100 (out of 100); consistent with excellent outcome. Specific assessments of neurological recovery affected by NTx(TM)-265 were also favorable, including the Arm Motor Fugl-Meyer Scale, an arm motor recovery assessment; Trailmaking A test, a measure of cognitive function; and measures of neglect and aphasia. Further, the drug regimen decreased the size of the infarct in 6 out of 8 patients overall, given a mean decrement in all 8 of about 10%.
Dr. Alan Moore, President and CEO of SCT, commented as follows:
"The encouraging results from this trial are consistent with results previously reported as an interim analysis on April 10, 2007 and suggest great promise for our NTx(TM)-265 treatment for stroke, but interpretation of results from the BETAS trial is limited by small patient sample size and absence of a placebo control group. Nevertheless, these results represent an important first step in defining the safety of the NTx(TM)-265 regimen in patients with acute neurologic injury. Equally promising is early evidence in a small group of patients that consistent recovery of motor, cognitive and visual function may occur as a result of NTx(TM)-265 neuro-regenerative therapy for stroke."
The next development step for SCT is to build upon the promising results from the BETAS clinical trial with the initiation of the REGENESIS proof of concept study. REGENESIS is a Phase IIb prospective, randomized, double-blind, placebo controlled study of NTx(TM)-265: human Chorionic Gonadotropin (hCG) and epoetin alfa (EPO) in acute ischemic stroke patients. The REGENESIS trial will be conducted at approximately 15-20 Canadian clinical trial centers and aims to enroll 134 patients in 2008.
The BETAS clinical data will be formally presented at the International Stroke Conference in New Orleans, LA, February 20-22, 2008. SCT will also be hosting a live audio webcast to review the results with Dr. Steven Cramer on Tuesday February 26, 2008.
Stem Cell Therapeutics Conference Call
SCT will be hosting a live audio webcast on Tuesday, February 26, 2008 at 1:00 PM EST to review the BETAS Phase IIa results with Dr. Steven Cramer. Participants may listen via audio webcast, accessible through the Company's website at www.stemcellthera.com or via telephone. The telephone conference number is 416-849-2698 or toll-free at 1-866-400-2270.
About NTx(TM)-265: NTx(TM)-265 is a therapeutic regimen of two approved and clinically well-defined drugs, human Chorionic Gonadotropin (hCG) and Erythropoietin (EPO), targeting the treatment of stroke. The objective of the regimen is to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the stroke. Animal studies have shown a significant recovery in motor function after receiving the NTx(TM)-265 regimen 24-48 hours post stroke. Similar results have been found in SCT's Phase IIa BETAS safety trial, as announced on April 10, 2007. SCT has initiated a multi-centre, double-blind, placebo-controlled Phase IIb REGENESIS study for NTx(TM)-265 with primary endpoints of efficacy.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (CDNX:SSS.V ) 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. The company's extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases.
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
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