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.