STROKE:  NTx®-265

The primary focus of SCT’s development activities is aimed at rapidly advancing NTx®-265 for the treatment of acute ischemic stroke. Stroke was chosen as the lead program because it represents both a large, attractive market opportunity with few competitors and a key first application for our neuro-regeneration technology platform.


A human stroke can be compared to a heart attack but located in the brain, and occurs due to a reduction in blood flow to certain regions due to a blockage, or rupture of a blood vessel’s wall. This interrupted blood flow causes a reduction in oxygen available to affected regions of the brain, and cells located there subsequently die. After an acute ischemic injury (stroke), brain tissue dies quickly in the absence of gas and nutrient exchange and has a limited capacity to spontaneously repair, regenerate or regain lost functionality. For this reason, injury due to stroke is frequently irreversible, recovery is insufficient and extensive recovery periods that range from months to years accompanied by intensive physiotherapy are required. Moderate to severe acute ischemic stroke is accompanied by the loss of a large number of neural cells within a patient’s brain. Loss of brain matter is accompanied by a varied array of symptoms including loss of cognitive function, loss of motor control to one side or both sides of the body, loss of visual and other symptoms that create a syndrome from which patient, family and medical practitioners must address. It is generally accepted that improved prognosis is directly related to maintenance of brain matter. Thus, this therapeutic approach using NTx®-265 for increasing regeneration of new, functional brain matter represents a novel approach that may directly influence a patient’s prognosis and the degree of improvement of a stroke patient’s symptoms. A final benefit that results from improved speed and robustness of recovery is decreased dependence of recovering patients on family and the medical system.

CLINICAL TRIALS

SCT conducted animal studies that showed a significant recovery in motor function in animals that received a stroke followed by the NTx®-265 therapy. SCT sponsored the investigator led BETAS (Beta-hCG + Erythropoietin in Acute Stroke) Phase IIa acute ischemic stroke trial in the United States and Canada in order to investigate the safety and efficacy of NTx®-265 in human stroke patients. This trial was the first to test the safety of NTx®-265 in patients suffering acute ischemic stroke and to conduct a preliminary assessment of functional recovery in this patient population. On April 10, 2007, the Company released interim results from the BETAS Phase IIa acute ischemic stroke trial and on February 20, 2008 SCT released further results from the BETAS trial, both of which showed positive outcomes.


SCT announced enrollment of the first patient in its original REGENESIS Phase IIb stroke trial on May 28, 2008. Enrollment in the U.S. Phase IIb study was expected to begin in Q4 2008 and finish in Q2 2009. Due to an unrelated German clinical study, the REGENESIS Phase IIb clinical trial was officially placed on clinical hold in September 2008 at the request of Health Canada and the U.S. Food and Drug Administration (“FDA”). At the time the clinical hold occurred on the REGENESIS Phase IIb stroke trial, 7 patients had been enrolled in the study. The clinical hold was formally lifted by the FDA on May 14, 2009. Health Canada approved the modified REGENESIS Phase IIb stroke trial on July 20, 2009 and the Drug Controller General of India (“DCGI”) followed shortly thereafter on July 21, 2009 issuing the Company a No Objection Letter (“NOL”) for the same protocol. The result of which allowed the Company to proceed with a modified REGENESIS Phase IIb stroke trial.


On May 21, 2009 the Company announced encouraging results from the original 7 patients enrolled in the trial prior to the clinical hold. The results of the Phase IIb trial from the 7 patients indicated an improvement in the treated group as compared to the placebo group. Of the 7 patients enrolled, 5 received placebo and 2 were treated with NTx®-265. A decrease in the NIHSS score represents an improvement in a patient’s functionality. A change of 4 units in the NIHSS scale is considered clinically significant. The placebo patients score decreased by an average of 1.4 units, which did not attain this level of clinical significance. The treated patients, however, showed an average decrease of 9 units, exceeding the level for clinical significance. While the results of this study were not statistically significant due to the small number of patients enrolled before the study was halted, the large numerical difference in response to drug regimen versus placebo is encouraging.


The next step in the clinical development for NTx®-265 is completion of the modified REGENESIS Phase IIb double-blind, randomized, placebo-controlled clinical stroke trial focused on functional outcome measures. This will involve approximately 128 stroke patients in a number of different centers in India, Canada and the U.S. Dr. Steven C. Cramer at the University of California, Irvine and Dr. Michael D. Hill at the University of Calgary, Calgary Health Region, are serving as co-Principal Investigators for this Phase IIb clinical stroke trial.


The Company is currently recruiting patients for the modified REGENESIS Phase IIb stroke trial and expects to complete all patient recruitment by the end of Q1 2010. Given that the protocol has a 90 day end-point, we anticipate a top-line data read by the end of Q2 2010.

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Date: 9/3/2010
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