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Spinifex Announces Start of Phase 2 Proof-of-Concept Trial of EMA401 in Postherpetic Neuralgia
Date:9/19/2011

MELBOURNE, Australia, September 19, 2011 /PRNewswire/ --

Spinifex Pharmaceuticals, an Australian pain drug development company, today announced the first patients have been treated in its Phase 2 clinical trial of EMA401 in postherpetic neuralgia (PHN), a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals.

The double-blind, placebo-controlled randomised trial is being conducted at centers in five countries and the first patient was treated at the clinic of Dr. Douwe De Jong in Pretoria, South Africa. Approximately 170 patients are expected to be enrolled in total.

The trial is designed to prove the concept of the use of EMA401, an angiotensin II type 2 (AT2) receptor antagonist, in PHN and determine its safety, tolerability and pharmacokinetic profile. The primary endpoint of the trial is reduction in mean daily pain score versus placebo over the last week of 28 days of treatment. Secondary endpoints include a number of further measures of pain and quality of life.

The discovery that AT2 receptor agonists offer an innovative approach to the treatment of neuropathic and inflammatory pain was originally made by Professor Maree Smith at The University of Queensland. Having acquired the technology, Spinifex has conducted a comprehensive pre-clinical and early clinical development program. EMA401 has shown efficacy in a number of relevant models and good human safety and pharmacokinetics in Phase 1 studies.

Spinifex Pharmaceuticals CEO Tom McCarthy said: "Today marks an important new step in the development of EMA401 and of Spinifex. We have successfully applied our development expertise to take a scientific discovery through early clinical development and now into proof-of-concept trials. This is the first of three Phase 2 trials to be initiated and we look forward to confirming the promise for EMA401 we ha
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SOURCE Spiniflex
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