11 Dec 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Spinifex Pharmaceuticals, an Australian pain drug development company, announced that the first set of patients have been treated in its phase II study of EMA401 in chemotherapy-induced peripheral neuropathy (CIPN), a painful and debilitating condition that develops in some patients receiving cancer chemotherapy. Use of EMA401, an AT2 receptor antagonist, as an innovative approach for treating neuropathic and inflammatory pain was originally discovered by Professor Maree Smith at the University of Queensland.
The primary endpoint of the study 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 II 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. I
In addition, a significantly greater proportion of patients on EMA401 reported a more than 30 percent 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.
Spinifex Pharmaceuticals CEO, Mr Tom McCarthy, said that, "Today's announcement marks another significant step in the development of EMA401 and for Spinifex. Our recent results for EMA401 in PHN served to highlight its potential as an entirely novel approach for the treatment of neuropathic pain. We look forward to completing this study in a second key indication and to moving EMA401 further towards being an important treatment for broader chronic and neuropathic pain indications."