Results of NeuroThera Effectiveness and Safety Trial - 2 (NEST-2) Presented at International...

Results of NeuroThera Effectiveness and Safety Trial - 2 (NEST-2) Presented at
International Stroke Conference 2009

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 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.

About PhotoThera
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.

Thomas C. Wilder, III, President and Chief Executive Officer of PhotoThera,
Inc., +1-760-496-3700, ext. 214, twilder@photothera.com