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Spinifex Announces Start of Phase 2 Proof-of-Concept Trial of EMA401 in Chemotherapy-Induced Peripheral Neuropathy
Date:12/10/2012

MELBOURNE, Australia, December 10, 2012 /PRNewswire/ --

Spinifex Pharmaceuticals, an Australian pain drug development company, today announces that the first patients have been treated in its Phase 2 study of EMA401 in Chemotherapy-Induced Peripheral Neuropathy (CIPN), a painful and debilitating condition that develops in some patients receiving cancer chemotherapy.

The study is an open label biomarker study being conducted at Hammersmith Hospital, London, UK. The trial is designed to provide proof of concept of the use of EMA401, an angiotensin II type 2 (AT2) receptor antagonist, in CIPN. Approximately 50 patients are expected to be enrolled into the trial. Patients will have received either taxane or platinum chemotherapy for any cancer type.

The primary endpoint is the change in mean spontaneous pain intensity score between baseline and the last week of 28 days of dosing using the Numeric Pain Rating Scale (NPRS). A number of secondary endpoints will also be evaluated including changes in nerve characteristics in skin biopsies taken from the calf pre-treatment and after EMA401 treatment at day 29.

Spinifex recently announced positive results from its Phase 2 study of EMA401 in post-herpetic neuralgia (PHN), a neuropathic pain which follows herpes zoster (shingles) in some patients. The primary endpoint of reduction in mean daily pain score over the last week of 28 days of treatment was met, with EMA401 showing a clinically meaningful and statistically significant improvement versus placebo. In addition, a significantly greater proportion of patients on EMA401 reported a more than 30% reduction in mean pain intensity score compared to baseline, meeting a key secondary endpoint. EMA401 was also shown to be generally safe and well tolerated with no serious treatment related adverse events reported.

Despite being a large and growing market, current therapy for chronic and neuropathic pain needs to be improved as a sig
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SOURCE Spinifex Pharmaceuticals
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