Results of NeuroThera Effectiveness and Safety Trial - 2 (NEST-2) Presented at International Stroke Confe...( Encouraging Safety and Efficacy Resul...),Health

Encouraging Safety and Efficacy Results Support Follow-on NEST-3 Trial

CARLSBAD, Calif., Feb. 20 /PRNewswire/ -- In a clinical trial sponsored by PhotoThera, Inc., transcranial laser therapy (TLT) for acute ischemic stroke within 24 hours of stroke onset demonstrated improved outcomes for patients, but did not meet statistical significance for efficacy. A post-hoc analysis in patients who had moderate to moderately severe strokes revealed a statistically significant treatment effect. These encouraging results support a follow-on phase III trial, NEST-3.

The results of the NEST-2 study (NeuroThera(R) Effectiveness and Safety Trial - 2) were presented at the American Heart Association's International Stroke Conference in San Diego, CA by Justin Zivin, M.D., Ph.D., Professor of Neurosciences at the University of California San Diego and Principal Investigator for the NEST-2 study. The results were also published online today in Stroke: Journal of the American Heart Association.

NEST-2 was a double-blind, sham-controlled (placebo) trial which enrolled 660 patients. Patients were eligible for inclusion in the study if they were 40-90 years of age, had moderate to severe strokes, and had not received tissue plasminogen activator (tPA). Initiation of treatment had to occur within 24 hours after stroke onset.

In NEST-2, TLT achieved a favorable outcome in 36.3% of patients compared to only 30.9% of patients in the sham group (p-value 0.094). The primary efficacy endpoint was a favorable 90-day score of 0-2 using the modified Rankin Scale (mRS). Mortality rates and serious adverse events (SAEs) did not differ between groups, providing further evidence of the safety of TLT.

A post-hoc analysis of 434 patients who suffered moderate to moderately severe strokes showed a favorable outcome in 51.6% of patients in the TLT group compared to 41.9% of patients in the
'/>"/>