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Logical Therapeutics Inc. Announces Results of Phase 1b Clinical Study of its Naproxen Prodrug

Monday, August 18, 2008 General News
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WALTHAM, Mass., Aug. 18 Logical Therapeutics, Inc., abiotechnology company focused on the development of medicines that treatdiseases associated with poorly controlled inflammation, announced today thesuccessful completion of its Phase 1b randomized controlled multi-dose safetyand pharmacokinetics study of LT-NS001, the Company's proprietary naproxenprodrug. The study, which was conducted from December, 2007 through July,2008 in normal adult volunteers, showed that LT-NS001 was well-tolerated bythe recipients. Moreover, when the subjects in the study were dosed twicedaily with LT-NS001 for seven days, plasma concentrations of naproxen werewithin the therapeutic range.
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LT-NS001 is a prodrug, which is converted in the bloodstream intonaproxen, a non-steroidal anti-inflammatory drug (NSAID). Naproxen is widelyregarded as the NSAID with the most favorable cardiovascular safety profileamong all of the drugs in this class. In pre-clinical studies in rats anddogs, LT-NS001 was shown to cause significantly less damage to thegastrointestinal tract than equivalent doses of naproxen. LT-NS001 hascompleted pre-clinical toxicology testing and was previously evaluated in aPhase 1a randomized controlled single-dose and multiple-dose study and shownto be well tolerated.
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"The robust pre-clinical data package for LT-NS001 suggests that thisnovel compound will provide patients with a drug that combines the efficacyand cardiovascular safety of naproxen while substantially decreasing the riskfor gastrointestinal ulceration," said Dr. Mitchell Fink, the President andCEO of Logical Therapeutics, Inc. "The results from our recently completed P1bstudy of LT-NS001 are very encouraging, because they show that administrationof the pro-drug leads to clinically useful circulating levels of naproxen."

Physicians and patients have accumulated more than 30 years of experiencewith naproxen, which is widely prescribed to treat pain and other signs andsymptoms of inflammation caused by chronic conditions, such as osteoarthritisand rheumatoid arthritis. Despite its considerable efficacy and its goodcardiovascular safety profile, naproxen, like most NSAIDs, can cause serious,even life-threatening, gastrointestinal complications. A safer alternativewould fulfill a significant unmet medical need.

The company expects to begin enrolling subjects in its next clinical studyof LT-NS001 later this year.

About Logical Therapeutics Inc.

Logical Therapeutics, Inc. is a privately held biotechnology company basedin Waltham, Massachusetts. Logical Therapeutics is developing drugs to treata variety of medical conditions that are associated with excessiveinflammation, including osteoarthritis and rheumatoid arthritis. For moreinformation on Logical Therapeutics, visit the company's website atwww.logicaltherapeutics.com or send an email to [email protected]

SOURCE Logical Therapeutics, Inc.
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