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news.Stem Cell Therapeutics' NTx-265 therapy for the treatment of stroke has posted positive interim results in a key preclinical study designed to prepare the way for the company to initiate a clinical phase IIa trial of the compound.
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This study utilized a clinically relevant model of stroke to validate the NTx-265 dose, timing and regimen anticipated for the proposed phase IIa study. The drugs used, the dose, the initiation time following stroke onset, and the treatment regimen all mimic the protocol anticipated to be tested in human stroke patients in the proposed phase IIa clinical study.
The results of this independently conducted, blinded, placebo-controlled six week study demonstrate a substantial and significant recovery of motor function following NTx-265 administration in the rat middle cerebral artery model of stroke.
NTx-265 therapy initiated 24 hours after stroke significantly improved composite neurological motor scores in rats compared to control animals that received saline treatment.
In addition, the company said that these findings support the premise that the therapeutic window for initiation of NTx-265 administration extends beyond the restrictive three hour window for thrombolytic therapies to a more clinically feasible treatment time of at least 24 hours following onset of stroke.