|The news about INGAP Protein is good now for the first time in years. Please see my blog at The INGAP Revival.|
When a major company like Eli Lilly withdraws its support for a potential drug, it's often the kiss of death. In April 1997 Lilly signed a licensing agreement with Eastern Virginia Medical School in Norfolk, Virginia, and McGill University in Montreal, Canada, to develop and commercialize a new way to treat diabetes. But the company cancelled the agreement in 1999.
“Chance favors the prepared mind.”
The research that Lilly supported looked promising when I wrote about it for the website of the American Diabetes Association.Now with a large cash infusion from the Procter & Gamble Company the chance of this treatment eventually coming to market appears positive again.
The deal was a P&G investment this April of about $30 million in GMP Companies with the promise of much more to come. GMP, a small healthcare company in Fort Lauderdale, Florida, in March 2000 had taken over the license that Lilly dropped for INGAP Peptide, which could reverse diabetes.
INGAP Peptide may be a long way from market, but it has already come far. The work began almost 20 years ago.
Dr. Aaron Vinik and Dr. Lawrence Rosenberg were young colleagues at the University of Michigan when they began to investigate islet cell regeneration. Subsequently Dr. Vinik moved on to the Strelitz Diabetes Institutes and Eastern Virginia Medical School. Dr. Rosenberg went to McGill University and the McGill University Health Center. But they continued to work together and eventually their universities patented their discoveries.
"When we started this work back in 1983, nobody believed that it was possible to cause a stem cell to grow into a new islet," Dr. Vinik recalls in an online discussion. "But we believed the pancreas had adult stem cells that we could reawaken."
As Louis Pasteur said in 1854, "Chance favors the prepared mind." Drs. Vinik and Rosenberg were prepared when their key discovery happened by chance. It was "SARANdipity."
They were actually trying to do something else. They wanted to know why pancreatitis became relentless once it started.
"We failed in this mission but noted that all the pancreases we wrapped in Saran had two-to-four fold the number of islets," Dr. Vinik said. "Instead of damaging a pancreas, it led to new islet generation. Afterwards, we showed that the Saran Wrap reversed streptozotocin-induced diabetes in hamsters, and we realized that we were on the path of discovery of an active principle."
At the time they called the principle "ilotropin." Ilotropin was the original crude extract of regenerating pancreases that they gave to animals, reversing their diabetes. For years they tried in vain to isolate a pure form of ilotropin, but its nature eluded them and they had to change course.
"We had to look within the pancreas that was growing again for a protein that was capable of stimulating new growth," Dr. Vinik says. "A new technology enabled us to go after the gene rather than the protein."
And in doing that they discovered Islet NeoGenesis Associated Protein (INGAP). This gene stimulates the growth of insulin-producing cells in the pancreas. In 1997 The Journal of Clinical Investigation announced their discovery.
Drs. Vinik and Rosenberg later identified the smaller, active portion of the INGAP gene. They isolated it and named it INGAP Peptide.
They initially met with the Food and Drug Administration in February 2001 and in July submitted the formal application of more than 2,800 pages. The FDA approved the testing program just two months later, "the fastest that any biologic compound for the potential treatment of diabetes has gone through the FDA for human testing," Dr. Vinik says.
GMP's interest is to make INGAP Peptide into a drug to treat diabetes. Last December the company began early human trials, which are scheduled for completion this summer. The study sites are research institutions in San Antonio, Texas, Chapel Hill, North Carolina, and Washington, D.C.
They haven't seen any side effects to INGAP Peptide, and it would appear to benefit people with either type 1 or type 2 diabetes. They don't know yet if people with type 1 diabetes will require immunosuppressive drugs. Many other questions remain, including the optimum dose and its frequency.
There are still miles to go, but this discovery could be really big. Dr. Vinik notes that some publications have hailed INGAP as important as insulin. In fact, he says, "When this all comes to fruition it will be more important. Insulin is not a cure but a panacea, and we hope that one day we will get beyond that."
The American Diabetes Association originally published this article on its Web site as one of my “About the Internet” columns.
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