Study seeks fix for Asian alcohol intolerance
Clinical trials in isles try to undo ‘Asian flushing’ effect of alcohol
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Thirty-two Hawaii residents are mixing science and vodka cocktails to test a drug to combat a condition known as "flushing" that occurs when Asians drink alcohol.
An undisclosed local research facility is conducting clinical trials with a drug called Convivia for Raptor Pharmaceuticals Corp.
The red-faced syndrome affects nearly half of East Asian populations, said Ted Daley, president of Bennu Pharmaceuticals, Raptor's clinical development subsidiary. It's caused by a metabolic disorder known as ALDH-2 (acetaldehyde deficiency), he said.
The volunteers, men and women of Japanese ancestry, undergo medical tests after drinking less than two glasses of vodka with and without the drug.
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Some days start with cocktail hour for 32 Hawaii residents of Japanese descent who are drinking vodka to help medical science.
They're participating in a clinical trial of a drug developed to treat "Asian flushing," or alcohol intolerance.
An underlying metabolic disorder known as ALDH-2 (acetaldehyde deficiency), it affects 40 percent to 50 percent of East Asian populations, said Ted Daley, president of Bennu Pharmaceuticals, clinical development subsidiary of Raptor Pharmaceuticals Corp.
Asians with ALDH-2 don't get just a little red-faced or have heart palpitations when they drink, Daley said in a telephone interview from California.
"Over time, they are repeatedly exposing themselves to a carcinogen at higher levels than would occur in the normal population."
Raptor Pharmaceuticals Corp., in Novato, Calif., purchased a San Diego pharmaceutical company and rights to a product called Convivia to reduce high acetaldehyde levels when people drink alcohol.
An undisclosed Honolulu research facility recruited 32 Japanese residents -- men and women -- with a history of flushing and side effects from alcohol for the study, Daley said.
He said the clinical trial is designed to test the impact of Convivia on acute physical responses to alcohol. It would be used to reduce symptomatic effects and uncomfortable reactions of drinking and, more importantly, reduce exposure to the toxin acetaldehyde, he said.
More likely, the next phase of clinical trials would be somewhere in Asia, Daley said.
If the drug is a success, it would be a boon for Raptor Pharmaceuticals, which estimated the potential market at $880 million just in Japan.
Daley said any alcohol could be used for the trials but vodka was chosen because it can be mixed with juices and may be more palatable to some participants.
On alternate days, they are given the alcohol and a substitute for the drug, or the alcohol with Convivia, he said.
They receive a measured amount of alcohol at the beginning of the day based on their body weight -- the equivalent of less than two drinks, he said.
They're in the clinic all day for tests of their blood, heart rate and temperature, their degree of flushing and more subjective responses, such as how they feel, Daley said.
The clinical program began April 21 and will be completed in a few weeks, he said. Patients have been studied in a series of groups over the weeks, he said. The total involvement for a participant is a couple of days, he said.
The next step in the clinical development of Convivia will be based on what they learn from the Honolulu residents, he said.
When he first became interested in the Asian flushing syndrome, Daley said, "I was really surprised that for something that affects so many people, there is nothing on the market for it.
"Up until recently, people tended to look at this as just a lifestyle issue. ... If somebody has enough alcohol, probably anybody is going to turn red after awhile," Daley added, "but this is a response to even a small amount of alcohol, an inborn metabolic disorder."
He said there was little awareness about the risks of digestive tract cancers, liver diseases and other serious health problems from the disorder, demonstrated only in the past 10 years.