WYNNEWOOD, Pa.—The founders and scientists of CureDM Inc. are among those in the pharma world looking for novel ways to treat diabetes—many of those methods involving ways to stimulate the pancreas to regenerate cells destroyed by diabetes. But what sets CureDM apart from most, and what got them some exposure in the peer-reviewed journal Endocrine Practice near the end of January, is their novel peptide that may actually lead to a method of recreating entire insulin-producing islets in the pancreas.
"A lot of people are pretty focused on replacing or regenerating beta cells in the pancreas, but that is just one of four cell types found in the islets," points out Loraine V. Upham, chief operating officer of CureDM. "What we need for people with diabetes is restoration of glucose control, and beta cells alone don't do that. You need other hormones besides insulin. Restoring insulin production or giving someone insulin doesn't control glucose really—it mostly just keeps them from dying because the insulin is what they most desperately need."
What CureDM has been focused on for the past couple years in particular is producing, stabilizing and characterizing a 14-amino acid human peptide, Human proIslet Peptide (HIP), consisting of the bioactive region in the human REG3a gene responsible for regenerating pancreatic islets, a process also known as islet neogenesis.
"Utilizing an innovative and proprietary approach to evaluate the human genome and proteome from a physiologic perspective, we were able to identify a highly conserved bioactive gene product that triggers islet neogenesis," says Dr. Claresa S. Levetan, chief medical officer and a founder of CureDM. "Restoring functional islets as a therapeutic approach is fundamental to curing the underlying disease."
In the Endocrine Practice article, CureDM shares preclinical research about HIP that demonstrates how HIP stimulates insulin secretion in human pancreatic ductal tissue devoid of islets. HIP was also shown to stimulate new islet formation with a threefold increase in islet numbers in validated diabetic animal models compared to placebo, effectively reversing the disease in such animals.
There is at least one other company, based in Canada, that is doing work similar to CureDM, Upham notes, but she says they are focused on proteins farther away from the pancreas in the pathway.
"When you go too far down the pathway and get too much distance from your target point, you can stimulate other things along the way, which can cause problems," Upham says. "We want to get to the heart of the matter, and we believe we can do that with HIP."
The incidence of diabetes has been growing at a double-digit rate worldwide, and projections have indicated that we may have nearly 300 million patients suffering from diabetes by 2030. At the time of diagnosis, islet mass is often reduced by 80 percent in patients with type 1 diabetes and 50 percent in patients with type 2 diabetes, which Upham notes supports the importance of islet restoration as a therapeutic approach.
"Having demonstrated the preclinical proof of concept of this promising and novel therapeutic approach, we look forward to obtain regulatory approval and initiation of clinical testing of HIP in 2009," says Dr. H. Joseph Reiser CEO of CureDM. DDN
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