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
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 sham group. This 9.7% treatment effect was statistically significant (p-value 0.044).
"TLT is one of the most promising new therapies that we've seen in a long time, especially as it may expand the treatment window for ischemic stroke to 24 hours. We look forward to commencing NEST-3 to further investigate TLT," stated Professor Werner Hacke, M.D., Ph.D., Chairman of Neurology at the University of Heidelberg, who will join Professor Zivin as Co-Chairman of the NEST-3 Steering Committee.
About Acute Ischemic Stroke
According to the American Stroke Association, stroke is the third leading cause of death in the United States. Ischemic stroke, which accounts for about 83 percent of all strokes, occurs as a result of an obstruction within a blood vessel supplying blood to the brain.
PhotoThera, Inc. (www.photothera.com), located in Carlsbad, CA, is developing transcranial laser therapy (TLT) for the treatment of acute ischemic stroke and other neurological diseases and disorders. The company was founded by Jackson Streeter, M.D., a former U.S. Navy flight surgeon and TOPGUN instructor.
|SOURCE PhotoThera, Inc.|
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