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A new treatment for diabetes may soon be available to millions of sufferers, thanks to a collaborative breakthrough by doctors Lawrence Rosenberg and Aaron Vinik. Pharmaceutical giant Procter & Gamble and biotechnology firm GMP Companies announced they are joining forces to develop and commercialize the Rosenberg-Vinik discovery.
PHOTO: Claudio Calligaris
This is big news for diabetics, since close to 500,000 people suffer from the disease in Quebec alone. Worldwide, diabetes is said to affect 130 million people. Diabetes occurs when the pancreas fails to produce enough insulin to break down sugar in the blood. Diabetes complications include vascular disease, kidney failure and blindness, and sometimes require amputations.
So far, the most common diabetes treatment has been synthetic insulin injections. When the Rosenberg-Vinik discovery comes onto the market, daily insulin injections could be a thing of the past.
Rosenberg, director of the division of surgical research in McGill's Department of Surgery and a researcher at the McGill University Health Centre, accidentally made his discovery while studying pancreatic cell proliferation in 1981, under the mentorship of the late William Duguid, a McGill pathology professor and pathologist-in-chief at the Montreal General Hospital site of the MUHC.
The two discovered that the adult pancreas possesses the ability to grow new insulin-producing cells. Vinik, director of the Strelitz Diabetes Research Institutes at Eastern Virginia Medical School (EVMS), teamed up with his McGill counterparts in 1986 to aid in the refinement of their breakthrough.
Now that Big Pharma is working on commercializing their discovery, says Rosenberg, two decades of work have been validated. "Our research is very controversial," he says, adding scientists are racing to find a diabetes cure. "It's a very competitive area and everybody believes theirs is the right approach."
Simply put, Rosenberg and Vinik discovered and cloned a gene that appears to treat the underlying causes of both type 1 (juvenile onset) and type 2 (adult onset) diabetes. The Rosenberg-Vinik discovery is called INGAP, for islet neogenesis associated protein, which is found in the pancreas.
INGAP is a protein that's responsible for the formation of new insulin-producing beta-cells and holds great promise for the regulation of glucose levels in diabetics. The treatment under development involves the injection of a small fragment of native INGAP, called INGAP peptide.
What's exciting about the treatment is how it's already proved successful in clinical studies in animals: mice, hamsters and dogs. In the animal trials, says Rosenberg, "we were able to reverse the disease and none of the animals suffered any side effects."
INGAP is currently in its first phase of human testing at three sites in the United States. So far, 20 patients have already been tested to determine if INGAP peptide produced any side effects in people. "To date," says Rosenberg, "no adverse events have been reported."
INGAP peptide will now be tested for its efficacy in a trial. Rosenberg cautions, however, that it could take several years before INGAP can be prescribed. "In a best case scenario it will be available on the market in five years," he says, adding that the U.S. Food and Drug Administration will conduct further INGAP testing before it is approved for commercialization.
If INGAP does prove to cure diabetes, it could potentially earn McGill, the MUHC and EVMS hundreds of millions of dollars in licensing revenues. How many millions isn't a matter of public record yet, though the MUHC and McGill will split their share 50-50 with EVMS.
However, Alex Navarre, director of the Office for Technology Transfer, which manages intellectual property and markets technologies from McGill and its affiliated hospitals through licences, cautions that the MUHC and McGill will not earn dividends on the Rosenberg-Vinik discovery overnight.
"While this is a very important licensing agreement that could potentially earn McGill millions of dollars in royalties," he says, "INGAP must hit the market before we earn any revenue. For all we know the discovery could take up to 10 years to be commercialized or hit a stumbling block one year from now, which is always possible."
Rosenberg is confident INGAP peptide will successfully pass its clinical tests and will help heal people. "It really looks like we're going to be helping millions of diabetics," he says.
The doctor, who before working at McGill studied at the University from 1971 to 1985, says he's glad his discovery will allow him to give back to his alma mater and employer. "I've been at McGill for the better part of my life," he says. "This discovery will be a tremendous boost for McGill, the University's Faculty of Medicine and the MUHC."