Saturday, May 25, 2013

Pushing Diabetes Into Remissions By Regenerating Islet Cells

By David Mendosa, Health Guide Wednesday, December 10, 2008

Maybe it won't cure diabetes. But a compound slated to begin a new Phase 2b clinical trial early next year stands a good chance of knocking diabetes back into remission.

Almost never do I write about new drugs unless they are at least in in the final stage of development, a Phase 3 trial. The odds are against them.

Of 100 drugs for which developers submit investigational new drug applications to the Food and Drug Administration for approval, about 70 will successfully complete Phase 1 trials and go on to Phase 2. About 33 of the original 100 will complete Phase 2 and go to Phase 3. And 25 to 30 of the original 100 will clear Phase 3.

And of the thousands of articles that I have written about diabetes in the past 14 years I can remember only three spotlighting drugs that hadn't entered Phase 3. One was my column on the American Diabetes Association's website in 2002 about the compound that came on the market three years later as Byetta.

The other two were both about INGAP peptide. Back in 1999 I broke the news about its potential to people with diabetes and followed up here two and one-half years ago.

But so many people keep asking me about about INGAP that I knew I had to check out its current status. And during the past two and one-half years INGAP has not only stayed the course but is beginning to move to market.

INGAP stands for islet neogenesis associated protein. That's not only a mouthful of a name, but also nowadays the term "regeneration of islet cells" is replacing the too technical "neogenesis." Maybe we should start calling it RICAP -- but that might confuse people even more.

By whatever name we call it, this natural protein stimulates regeneration of islet cells capable of producing insulin and other metabolic hormones. It stimulates the development not just of beta cells but also of fully functioning islet cells with all of the metabolic hormones that can be regenerated from precursor cells residing in the pancreas. We can think of it as turning back the clock on the diabetes.

The many calls and emails that I keep receiving prompted me to contact some of the top people at the start-up company that is developing INGAP. This week I interviewed Zoe Heinenman Myers, vice president of marketing for Kinexum Metabolics Inc. in Burnsville, Minnesota, and then at length with Lisa Jansa, the company's new CEO.

She is one of the company's co-founders, along with Alexander Fleming, MD, a former supervisory medical officer in the division of metabolic and endocrine drug products at the Food and Drug Administration, and Kevin Roche, a former CEO of Ingenix. Dr. Fleming and Lawrence Rosenberg MD, who together with Aaron Vinik, who now leads Eastern Virginia Medical School's Strelitz Diabetes Center, discovered INGAP, reviewed its status last year in "Prospects and Challenges for Islet Regeneration as a Treatment for Diabetes: A Review of Islet Neogenesis Associated Protein."

What other drug candidates might lead to regeneration of islet cells? Lisa says that she knows of only one such company that has a compound in a Phase 2 trial, Transition Therapeutics in Toronto, Canada. They call it TT223, and they are currently recruiting people with type 2 who are taking metformin and/or a thiazolidinedione.

By David Mendosa, Health Guide— Last Modified: 10/11/11, First Published: 12/10/08