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news.Raptor Pharmaceuticals, a development-stage biotechnology company, has entered into an agreement with the Centre Hospitalier Universitaire d'Angers of France to evaluate the company's proprietary delayed-release cysteamine bitartrate in a Phase II clinical trial in patients with Huntington's disease.
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Centre Hospitalier Universitaire d’Angers (CHU d’Angers) has received a grant from the Programme Hospitalier de Recherche Clinique – National, a program under the French Ministry of Health, to fund the two-year, multi-center Phase II clinical trial in Huntington’s patients. Under the terms of the agreement, Raptor will provide clinical supplies of delayed-release (DR) cysteamine for the trial.
The primary endpoint of the Phase II trial will be evaluated using the Unified Hungtington’s Disease Rating Scale. The secondary endpoint will measure brain-derived neurotrophic factor levels, known to be deficient in Huntington’s patients.
Ted Daley, president of Raptor’s clinical division, said: “We look forward to collaborating with CHU d’Angers to evaluate DR cysteamine in patients with Huntington’s Disease. Our formation work with DR cysteamine in conjunction with the CHU d’Angers studies in Huntington’s fits our strategic plan to explore multiple potential indications for cysteamine and DR cysteamine .
“Cysteamine has demonstrated neuroprotective effects in preclinical studies, and the planned Phase II study led by CHU d’Angers could confirm existing data regarding cysteamine’s safety and potential efficacy in Huntington’s.”