Raptor Pharmaceuticals Corp. Initiates Phase IIa Clinical Study for Co... (DH2 deficiency and people with this diso...)

Raptor Pharmaceuticals Corp. Initiates Phase IIa Clinical Study for Convivia(TM)

Date:4/21/2008

DH2 deficiency, and people with this disorder could potentially benefit from a treatment that reduces acetaldehyde toxicities.

Convivia(TM) is designed to reduce peak systemic acetaldehyde levels in ALDH2 deficient persons following alcohol consumption. 4-MP, the active ingredient in Convivia(TM) and used in this Phase IIa study, is FDA-approved in an injectible formulation for other indications, but is investigational for treatment of acetaldehyde toxicities associated with ethanol exposure in ALDH2 deficient subjects.

Ted Daley, president of Bennu, stated, "ALDH2 deficiency is fueling a public health concern among clinical geneticists within the Asian medical community, which underscores the need to address this patient population with an effective treatment option. Although the risks of cancers and other health problems associated with this disorder have been documented in numerous studies over the past several years, they are not widely known to the general population or to the substantial proportion of Asians who are at risk. Even light to moderate ethanol intake may expose people with this condition to increased risks for serious diseases without them realizing it."

Phase IIa Clinical Trial of Oral 4MP

Bennu's Phase IIa clinical study is being conducted in Hawaii. The study is examining an oral administration of the current liquid injectible dose form of 4-MP that is marketed in the United States for other indications. Up to 32 subjects of Japanese descent who have a history of flushing reactions from alcohol will participate in a randomized, double-blind, placebo-controlled, dose escalation study of this orally administered liquid 4-MP or placebo, concomitant with ethanol. Participants will give subjective responses on severity of their symptomatic reactions and investigators will measure their blood levels of acetaldehyde and ethanol as well as heart rate and skin temperature, in order to evaluate tolerability, safety and efficacy
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