New Delhi, Jan. 28: A biochemical engineer in Chile has chosen India as the site for animal studies to test what he says could be the world’s first “vaccine” against alcoholism to get problem drinkers to quit on their own.
Juan Asenjo, director at the Centre for Biochemical Engineering and Biotechnology at the University of Chile, said the pre-clinical studies of the candidate vaccine developed there would be conducted in India.
“We’re hoping these studies will begin next month,” Asenjo told The Telegraph over phone. He said the University of Chile had contacted the Sanctuary for Research and Development (SA-FORD), a clinical research agency in Navi Mumbai for pre-clinical studies. SA-FORD specialises in toxicological studies on rodents.
Pre-clinical studies typically involve administering mice or rats a new candidate drug or vaccine to determine whether it has any harmful side effects. Pre-clinical studies always precede human trials of any product.
Asenjo said the vaccine made from genetic material was called an anti-sense molecule that blocked synthesis of the second of two key enzymes that are involved in the normal breakdown of alcohol in the body.
The anti-sense molecule inactivates a gene in the liver that blocks synthesis of the enzyme which leads to an accumulation of aldehyde in the body. The aldehyde accumulation is expected to cause nausea and headache and make heavy drinkers feel so terrible after drinking that they will stop the habit on their own, Asenjo said.
Asenjo, who is also the president of the Chilean Academy of Sciences, said the idea of treating alcoholism by inactivating a gene emerged after studies showed that some populations in eastern Asia were unable to tolerate alcohol because of genetic variations that couldn’t break down aldehyde.
“We’re awaiting a final go-ahead from the University of Chile,” Shashi Nair, head of operations at SA-FORD told The Telegraph. “We’ll then submit the testing protocols for approval by an institutional animal ethics panel. If all goes according to plan, we could begin the studies in February.”
He said first phase clinical trials of the candidate vaccine against alcoholism would be conducted in Chile later this year after results from the pre-clinical studies in India had been received. Phase I trials are the first set of trials in humans, primarily intended to evaluate the safety of the product.
Five years ago, biologist Yedy Israel at the University of Chile and his colleagues demonstrated what some scientists believe was the “proof-of-principle” that administering an anti-sense molecule to “alcoholic” rodents can curb their urge to drink.
In research published in the journal Alcoholism: Clinical and Experimental Research, the Chilean scientists reported that rats initially bred into heavy alcohol drinkers and made alcohol-dependent reduced their alcohol intake by nearly half after a single injection of the anti-sense therapy.
People who are naturally born with such a mutation experience nausea, facial redness, and a pounding heart when they drink alcohol, Israel had said in a media release issued by the University of Chile in 2008.
The anti-sense molecule inactivates a gene in the liver that manufactures the aldehyde dehydrogenase-2 enzyme that is needed to break down the products of alcohol in the body.