Stem Cell Therapeutics Corp. Announces Positive Interim Results From its Currently Enrolling Phase IIa Clinical Program for NTx(TM)-265 in Acute Stroke
- Category: Proteins and Peptides
- Published on Wednesday, 11 April 2007 03:00
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CALGARY, Canada | April 10, 2007 | Stem Cell Therapeutics Corp. ("SCT")(TSX VENTURE: SSS) is pleased to announce positive interim results from its currently enrolling Phase IIa- Safety Trial study "Beta-hCG + Erythropoietin in Acute Stroke".
This uncontrolled open label safety trial was designed to determine whether NTx(TM)-265 could be safely administered to a population of patients with acute stroke. In addition to the trial's primary safety endpoint, a number of secondary endpoints are being studied to characterize early indicators of efficacy in patients receiving this novel stroke therapy. A review of the design of this clinical trial can be viewed at www.clinicaltrials.gov/ct/show/NCT00362414 and on SCT's website under Dr. Steven Cramer's poster presentation from the International Stroke Conference, Feb 2007.
To date, five patients have been enrolled. Each had a moderate to severe stroke, defined by study entry criterion of National Institute of Health Stroke Scale (NIHSS; http://www.ninds.nih.gov) score between 6 (moderate) and 24 (severe); 0 being normal and 30 being non-responsive or comatose. Of these, four patients have safely completed the NTx(TM)-265 regimen of human chorionic gonadotropin (hCG) and erythropoietin (EPO), initiated 24-48 hours after stroke. Thus far, no drug-related Serious Adverse Events (SAE's) have been noted. A fifth study patient, a 79 year-old female with concomitant myocardial infarct and multi-organ failure, died before dosing was completed. This SAE was judged completely unrelated to the study drug regimen.
Accompanying the primary safety endpoint measures in this study is a battery of secondary endpoints that measure functional recovery. An earlier preclinical stroke study in rats established the proof of principle and impetus for proceeding into this clinical trial by demonstrating that administration of NTx(TM)-265, as compared to a placebo, was associated with rapid and robust recovery of visual and tactile motor control of forelimb function, as well as reduced final infarct volume. Infarct volume is the term used to describe the volume of brain tissue affected by blockage of blood flow to that tissue. Interim results from the current Phase IIa NTx(TM)-265 stroke clinical trial show that each of the patients who completed the therapy demonstrated significant recovery from their stroke symptoms. In addition, MRI readings at days 1 and 90 post-stroke, available from two of the patients, indicate that infarct volume had been reduced by 39-79% over this 90-day period. A copy of the MRI photos from one of the patients can be viewed at: http://www.ccnmatthews.com/docs/sct-link1.pdf.
Each of the four patients who completed therapy to date was screened, enrolled, and had a stroke of moderate severity (enrolees have had baseline NIHSS score ranging from 6 to 10), and presented with a constellation of symptoms. The most common symptoms have been weakness and neglect, the latter referring to reduced attention to half of the visual space. Prior studies suggest that as many as 30% of patients hospitalized with a moderate-severe stroke can spontaneously recover within 90 days of stroke onset, with recovery being defined as achieving either a final NIHSS score of 0 or 1, or a decrease of at least 4 points in this scale. In the present study, all patients who have completed treatment and been evaluated out to day 90 have shown such a level of recovery. Further, each of these patients demonstrated a multifaceted improvement across their constellation of neurological deficits. An example of a patient's recovery from neglect after receiving NTx(TM)-265 can be viewed here: http://www.ccnmatthews.com/docs/sct-link2.pdf.
Dr. Steven Cramer, Principal Investigator, commented as follows:
"While the number of patients studied thus far is small and interpretation is complicated by absence of a placebo control group, the level of recovery seen is remarkable and parallels results from the preclinical studies."
Dr. Alan Moore, President and CEO of SCT, commented as follows:
"The results to date are extremely promising. All of the patients that were fully treated had at least one significant impairment resulting from their stroke and in each case the measured recovery was substantial. The MRI data, which shows substantial regeneration of lost brain tissue, lends strong support to the efficacy of our therapy. We are hoping to complete enrolment of the final eight patients in the Phase IIa study by the end of Q3 and report final results from this study in Q4. Given the positive initial results, we are already preparing for a Phase IIb double-blind, randomized, placebo-controlled clinical trial focused on functional outcome measures. This would involve approximately 120 stroke patients in a number of different centers in North America and we hope to begin this program before year-end. Dr. Steven Cramer at the University of California, Irvine and Dr. Michael Hill at the University of Calgary, Calgary Health Region, have agreed to serve as co-Principal Investigators for this Phase IIb program."
About NTx(TM)-265: NTx(TM)-265 is a therapeutic regimen of two drugs being developed by SCT for the treatment of stroke. Human chorionic gonadotropin (hCG) is the first drug administered in the regimen, and aims to increase the number of neural stem cells (NSCs) located in the brain of a patient suffering from a recent stroke. Erythropoietin (EPO) is the second drug administered in the regimen, and aims to promote the differentiation of these newly formed NSCs into new neurons. New neurons thus formed are anticipated to provide benefit to the patient through the replacement of the brain cells that were lost or damaged by the stroke. Animal studies have shown a significant recovery in motor function in animals that have been given a stroke and subsequently been treated with the NTx(TM)-265 therapy. SCT is currently enrolling patients in a phase IIa clinical trial in the United States in order to investigate the safety and efficacy of NTx(TM)-265 in humans.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. (SCT) is a biotechnology company 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 currently enrolling phase IIa clinical program for NTx(TM)-265 targets the treatment of stroke by repurposing approved and clinically well defined drugs. The company's extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases.
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SOURCE: Stem Cell Therapeutics Corp.