WYNNEWOOD, Pa., April 30 /PRNewswire/ -- CureDM, Inc., a biopharmaceutical company developing new therapies that prevent, ameliorate, or reverse both type 1 and 2 diabetes, announces its achievement of a major drug development milestone for Human proIslet Peptide (HIP). CureDM has successfully stabilized HIP to improve its bioavailability with recent dose response studies indicating that the dosage used in man may be as much as 100-fold lower than the native form. HIP is a 14-amino acid human peptide derived from a specific human gene responsible for populating the pancreas with islets, which contain the cells that secrete insulin and other hormones necessary to prevent diabetes.
"Meeting this milestone has a significant impact on the commercial value of Human proIslet Peptide," according to Loraine V. Upham, CEO. "Not only does this mean lower costs associated with the manufacture and commercialization, but also potentially better safety and tolerability outcomes in human trials." CureDM has filed with the FDA and anticipates approval for commencement of human studies in early 2009.
Further studies are underway to determine just how low of a dose is possible. Previous studies have confirmed that the stabilization of HIP did not adversely affect the efficacy and demonstrated that normal glucose levels were achieved after 25 days of treatment and remained normal after the therapy was stopped.
Human proIslet Peptide (HIP) stimulates the differentiation of pancreatic progenitor cells, which are present in the adult pancreas, into new insulin-producing islets. Each new islet contains pools of beta cells which make insulin. It is hypothesized that treatment with this therapeutic will restore human pancreatic function without the use of stem cells.
The CureDM approach to restore new insulin-producing cells through islet neogenesis can potentially reverse both type 1 and type 2 diabetes. Patients with type 1 diabetes will require pretreatment with an immune tolerance agent to protect new islets formed by HIP. CureDM, Inc., located at the Lankenau Institute for Medical Research on the Lankenau Hospital campus in Wynnewood, PA, is developing peptide therapeutics using a platform that combines bioinformatics, proteomics and Human Genome sequence data. This method has enabled the CureDM scientific team to determine the proteins involved in, and probable mechanisms of islet neogenesis in humans. For more information about CureDM, visit www.curedm.com.
SOURCE CureDM, Inc.