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news.Canadian biopharmaceutical company Isotechnika has completed patient recruitment for its pivotal phase III European/Canadian trial of its psoriasis drug.
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As of July 20, 2007, the company closed recruitment at 638 patients. The patient population is made up of 228 Canadian patients, 294 patients from Germany and 116 patients from Poland.
“We are pleased that patient recruitment was achieved in the anticipated timeframe,” stated Dr Randall Yatscoff, Isotechnika’s president and CEO. “The ability to complete recruitment quickly speaks to the unmet medical need for a treatment for this serious and debilitating disease. This is a major milestone in facilitating the advancement of ISA247 towards final marketing approval for the treatment of psoriasis.”
A second pivotal phase III European psoriasis trial including approximately 360 patients is expected to commence in the first quarter of 2008. The company anticipates that the two trials, will provide sufficient patient numbers to file for regulatory approval in Europe and Canada.