Stem cell therapy for stroke NTx-265 flunks in patient studies

NTx-265, en experimental stem cell-based therapy to treat acute ischemic stroke, has failed in human trials, announced Stem Cell Therapeutics Corp.

NTx-265 for ischemic stroke is already underway in India.

Drug Controller General of India (DCGI) gave approval for  NTx-265 for ischemic stroke protocol on July 21, 2009 issuing the company a No Objection Letter (NOL) for the same protocol.

The clinical trials NTx-265 for ischemic strokeare being conducted in India, Canada and the U.S.

96 patients have been enrolled to-date in Stem Cell Therapeutics’ modified REGENESIS Phase IIb acute ischemic stroke study.

Results for Phase IIb stroke trial showed that no substantial improvement in the patients who received NTx-265.

The modified REGENESIS- Phase IIb trial, has bee a placebo controlled, double blinded,  randomized clinical study, enrolled 96 patients with acute ischemic stroke between August 2009 and January 24, 2010.

NTx-265 was well tolerated in treated patients with no adverse affect on mortality.

Of the 96 patients enrolled in the trial, 72 patients were administered a course of NTx-265, sequential administration of human chorionic gandotropin (hCG).

It was followed by erythropoietin (EPO), with the first dose at 24-48 hours after stroke onset while 24 patients were treated with placebo.

All patients were then monitored for 90 days.

“We are currently conducting a validation review process of the full trial. We expect to report on the outcome of this within the next 2-3 weeks, together with results from a number of secondary endpoints such as modified Rankin and Barthel index, which may provide an alternative to NIHSS as a pathway forwards,” stated Dr. Alan Moore, CEO and President of Stem Cell Therapeutics.

Stem Cell Therapeutics Corp. is a public biotechnology company focused on the development and commercialization of drug-based therapies to treat central nervous system diseases.

SCT’s programmes aim to repair brain and nerve function lost due to disease or injury.

The company’s extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases such as traumatic brain injury, multiple sclerosis, Huntington’s disease, Alzheimer’s disease, and ALS.

On May 21, 2009 Stem Cell Therapeutics 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.