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

Raptor
Pharmaceuticals Corp. ("Raptor" or the "Company") (OTC Bulletin Board:
RPTP), announced that its clinical development subsidiary, Bennu
Pharmaceuticals Inc. ("Bennu"), has initiated the Company's first
clinical-stage program after dosing the first cohort in a 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 Bennu's proprietary, oral formulation of 4-MP
designed to reduce peak systemic acetaldehyde levels in ALDH2 deficient
persons following alcohol consumption.


ALDH2 deficiency, sometimes referred to as "Asian flushing syndrome,"
is an inherited metabolic disorder affecting 40% to 50% of East Asian
populations, impairing the activity of the liver enzyme aldehyde
dehydrogenase ("ALDH2"). When people with ALDH2 deficiency drink alcoholic
beverages, there is an accumulation of acetaldehyde, a carcinogenic
intermediate in the metabolism of ethanol, in blood and tissues. Published
retrospective studies have observed a significant correlation between
recurrent drinkers with ALDH2 deficiency and an increase in risk for
digestive tract cancers, liver diseases, late-onset Alzheimer's disease and
other serious health disorders. In addition to the long-term health risks,
elevated acetaldehyde levels produce acute symptoms, including facial
flushing, tachycardia (rapid heart rate), headache, nausea and dizziness.



Although ALDH2 deficient people suffer from unpleasant reactions and
face long-term health risks, a substantial proportion of them are recurring
drinkers of alcoholic beverages. Currently there are no approved treatments
for ALDH2 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