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Logical Therapeutics Announces Positive Results of LT-NS001 vs. Naproxen Clinical Study
Date:10/27/2009

-NS001 with our next study scheduled to begin later this year."

Key Findings Presented at ACG

In this study, 120 normal volunteers aged 45 to 70 years received either LT-NS001 (n=61) or Naprosyn(®) (naproxen) (n=59) for seven days and underwent an upper GI endoscopy at baseline and on day seven to visualize the extent of GI injury. At the conclusion of the study, nine subjects (15.8%) had developed gastric ulcers while taking naproxen, compared with only two subjects (3.3%) on LT-NS001, a 78 percent reduction in the incidence of gastric ulcers (p=0.02). The total number of ulcers that developed in the naproxen arm was twenty-nine (29) compared to only three (3) in the LT-NS001 arm, leading to a significant difference in the mean number of gastric ulcers per subject (p=0.03). Additionally, subjects receiving LT-NS001 developed no duodenal ulcers. The primary endpoint for the trial, total modified gastroduodenal Lanza score (an indicator of GI injury) demonstrated less overall GI mucosal injury in the LT-NS001 subjects as compared to subjects receiving naproxen (p=0.03). Treatment emergent adverse events also favored LT-NS001 with no serious or severe adverse events, including fewer incidences of abdominal pain, gastritis and dyspepsia.

"The results of this initial study demonstrate a potential new approach to the treatment of patients who suffer from chronic painful diseases such as osteoarthritis with the use of an NSAID having the possibility of a lower incidence of GI side effects traditionally associated with naproxen," said Thomas J. Schnitzer, MD, PhD, Professor of Medicine, Internal Medicine/Rheumatology at Northwestern University Feinberg School of Medicine. "LT-NS001 has the potential to be a very valuable option for patients and health care providers if further studies with LT-NS001 demonstrate a reduced risk for NSAID-induced GI complications, a side effect which often results in discontinuation of arthriti
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SOURCE Logical Therapeutics, Inc.
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