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Raptor Pharmaceuticals Corp. Announces Positive Phase IIa Clinical Study Results for Convivia(TM) Program
Date:11/11/2008

Reduction in Tachycardia and Blood Acetaldehyde Levels in Subset of Subjects with Inborn Error of Alcohol Metabolism

NOVATO, Calif., Nov. 11 /PRNewswire-FirstCall/ -- Raptor Pharmaceuticals Corp. ("Raptor" or the "Company") (OTC Bulletin Board: RPTP), today announced positive results in its Phase IIa study of oral 4-methylpyrazole ("4-MP") in subjects with ALDH2 deficiency, or ethanol intolerance, as the initial development stage of its Convivia(TM) program. Convivia(TM) is Raptor's proprietary oral formulation of 4-MP designed to reduce systemic acetaldehyde exposure and related symptoms in ALDH2 deficient persons following alcohol consumption. 4-MP, the active ingredient in Convivia(TM) and used in this Phase IIa study, is marketed in an injectible formulation for other indications, but is investigational for treatment of acetaldehyde toxicity associated with ethanol exposure in ALDH2 deficient subjects.

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Conducted in Hawaii, the blinded, intra-subject controlled, single dose, dose escalation study enrolled 32 subjects of Japanese descent with a history of symptoms of inborn altered ethanol metabolism with concomitant ethanol exposure. At the time of enrollment, study subjects also submitted to alcohol dehydrogenase ("ADH") and aldehyde dehydrogenase ("ALDH2") genotyping. The objectives of the study were to investigate the safety and efficacy of 4-MP as a potential treatment of symptoms resulting from acetaldehyde toxicity in ALDH2 deficient subjects who drink alcohol. The trial also sought to provide information leading to the most efficacious dose and dosage timing range.

The study results demonstrated that the active ingredient in Convivia(TM) significantly reduced heart palpitations (tachycardia), which are commonly experienced by ALDH2 deficient people who drink, at all dose level
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SOURCE Raptor Pharmaceuticals Corp.
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