Stem Cell Therapeutics Corp.

Stem Cell Therapeutics Corp.

October 17, 2006 08:30 ET

Stem Cell Therapeutics Announces Publication of Positive Phase II Efficacy Results of Schizophrenia Program Under Option

CALGARY, ALBERTA--(CCNMatthews - Oct. 17, 2006) -

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Stem Cell Therapeutics Corp. (TSX VENTURE:SSS) ("SCT") is pleased to announce the advance online publication of the results of a Phase II schizophrenia study using rhEPO by infusion (a therapy under option to SCT) in the journal, Molecular Psychiatry, a member of the Nature Publishing Group. The double-blind, placebo-controlled, proof-of-principle Phase II trial demonstrated a statistically significant improvement in patients receiving infusions of rhEPO over placebo in schizophrenia-related cognitive performance.

Phase II Trial Design

The Phase II trial, a double-blind, placebo-controlled, randomized, multi-center trial performed in Germany, evaluated cognitive function in chronic schizophrenic men with defined cognitive deficit, stable medication and disease state when treated with an infusion of rhEPO. Patients (N=39) aged 25-50 were randomly assigned to treatment (N=20) or placebo (N=19) groups. Patients received weekly 15 minute infusions of rhEPO (40,000 IU, EPO-beta, Roche) or placebo for a 12 week study duration. Study end points, tested over 2 days at baseline, and at 2, 4 and 12 weeks of study participation, included the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS; ARAB design) and the Wisconsin Card Sorting Test (WCST-64).

Phase II Results

172 patients were screened, with 43 patients fulfilling the enrolment criteria and 39 completing the study. No unexpected side effects, no adverse events and no complaints of the participating patients were identified throughout the study.

Repeated-measures ANCOVA using the composite score of the set of schizophrenia-related cognitive tests as the dependent variable and treatment as the independent variable, together with age as covariate, revealed a significantly better outcome of EPO as compared to placebo-treated patients, whether using raw data or calculating cognitive improvement based on the individual baseline level. Cognitive tests other than those selected as the "schizophrenia test set", and motor tests did not differ between groups upon inclusion or during follow-up.

In addition to the schizophrenic test set cognitive score results, serum levels of the glial damage marker S100B, starting from almost identical baseline concentrations, showed a significant decrease in the EPO group at week 12. S100B concentrations have been correlated with the extent of brain damage occurring in neurodegenerative disorders, as well as traumatic or focal insults.

"According to the study authors, until now no drug has been clearly shown to have lasting beneficial effects on cognition in schizophrenia", said Dr. Joseph Tucker, President and CEO. "We consider this early proof of concept data of a drug with effects specific to cognition to be very encouraging."

About the lead author of the study, Dr. Ehrenreich: Professor Dr. Hannelore Ehrenreich studied human and veterinary medicine in Hanover and Munich, Germany. In parallel to her clinical training in neurology and psychiatry (in Munich and Gottingen) she had several grant-funded research associations in the USA (NIAID, NIH, Bethesda, MD), the UK and the Philippines. She is professor and clinical consultant for neurology and psychiatry, with teaching responsibilities at the University of Gottingen. She is Head of the Division of Clinical Neuroscience at the Max Planck Institute of Experimental Medicine, Gottingen. Dr. Ehrenreich has over 110 original publications in peer-reviewed international journals. Dr. Ehrenreich is also a member of the Clinical Advisory Board of Stem Cell Therapeutics.

About the Option to Acquire agreement: On September 13, 2006, SCT announced that it entered into an Option to Acquire agreement for up to two additional clinical stage programs, one in schizophrenia and the other in multiple sclerosis, with researchers from the Max Planck Institute of Experimental Medicine in Germany. The agreement provides SCT with the right, but not the obligation, to acquire one or both of the clinical stage programs under option. The two clinical programs described in the agreement are each based on therapeutic approaches to treating CNS disorders with erythropoietin (EPO) and are protected by pending patent applications. SCT will pay no fees in association with the Option to Acquire unless exercised. If exercised SCT will pay certain upfront, milestone and clinical trial support costs in respect of any programs acquired. Conditions of exercising the Option to Acquire by SCT include satisfactory completion of due diligence, approval by SCT's board of directors, and the determination that sufficient resources are available so that SCT can advance the optioned program(s) without impeding the advancement of our lead NTx™-265 stroke program. The term of the agreement is for a period of six months beginning September 13, 2006, and may be extended at no cost for an additional six months upon mutual agreement.

The Phase II study results announced today are part of the schizophrenia program optioned to SCT under the Option to Acquire agreement. SCT has not yet determined whether, at its sole discretion, it will exercise the option for either or both of the schizophrenia or multiple sclerosis programs. There is no assurance that SCT will elect to exercise its option.

About NTx™-265: NTx™-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.

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. Our currently enrolling phase IIa clinical program for NTx™-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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