People often ask me whatever happened to INGAP Peptide, which looked like one of the most promising ways to regenerate islet cells. Until this week the news wasn't good.
In 2002 I first wrote about INGAP - islet neogenesis associated protein - in my column on the Web site of the American Diabetes Association. At that time it already has suffered one major setback, when Lilly backed out of an agreement with the licensee, GMP Companies, to commercialize it.
Then, Procter & Gamble, sublicensed INGAP Peptide. But, after the Phase 2 clinical trials "did not consistently demonstrate a clinically meaningful therapeutic benefit," P&G too gave up and returned the license to GMP Companies.
Now, Kinexum Metabolics Inc., located in Harpers Ferry, West Virginia, has sublicensed INGAP Peptide from GMP Companies for more clinical trials. Created just last year, Kinexum considers INGAP Peptide to be its "lead compound," according to a corporate summary that Dr. G. Alexander Fleming sent me.
Dr. Fleming is Kinexum's president and CEO. Earlier he served for 12 years as the Food and Drug Administration's senior endocrinologist and clinical group leader for the evaluation and regulation of diabetes and metabolic therapies.
Dr. Fleming and his company have analyzed P&G's Phase 2 trials and concluded that they were poorly designed. So Kinexum is going back to the drawing boards with more trials.
Dr. Fleming says that he believes that INGAP Peptide "offers excellent prospects for a breakthrough therapy and the achievement of a major scientific milestone." He told me that it will help both people with type 1 diabetes and those of us with type 2 who use insulin.
"If you look at the Procter & Gamble type 2 study, you will see that there was nearly a 1 percent improvement in A1C," he says.
Developing a new diabetes drug always takes years. In this case, Dr. Aaron Vinik and Dr. Lawrence Rosenberg, then at the University of Michigan, began to investigate islet cell regeneration in 1983. Their research announcing the discovery of INGAP was reported in the May 1997 issue of the Journal of Clinical Investigation.
Then came the setbacks with Lilly and P&G. The news about INGAP is a lot better now.
But there is still a long way to go. Dr. Fleming believes that if the trials are successful and if the FDA agrees, INGAP Peptide could be available for commercialization in 2009.
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