Kinexum Metabolics, Inc. (KMI) announced two abstracts will be presented on INGAP Peptide at the Keystone Symposia on Islet and Beta Cell Biology to be held April 6-10, 2008. These two studies demonstrate important new data to advance the development of INGAP Peptide as a treatment to regenerate fully functioning islet cells that can restore insulin secretion for Type 1 diabetes patients. “We are encouraged by these new studies and believe they demonstrate great potential for INGAP Peptide as a therapeutic approach for Type 1 diabetes and insulin-dependent Type 2 diabetes,” stated Dr. Alexander Fleming, founder and Chief Medical Officer of KMI and a well-known authority on metabolic drug development. “These new data demonstrate for the first time induction of endocrine cells from a human pancreatic ductal cell line in vitro and the use of combination therapy to induce islet regeneration and clinical remission in a model of established (not new onset) T1 diabetes.”
Further Demonstration of INGAP Neogenesis Activity in Humans
One study to be presented was conducted by Dr. Lawrence Rosenberg and colleagues at McGill University Health Centre (MUHC). Adult human pancreatic duct cells treated with INGAP Peptide for 24 hours resulted in substantial increases in expression of insulin and PDX, an endocrine cell marker. These results not only demonstrate INGAP’s endocrine cell-induction activity in human tissue, they also suggest that islet progenitor or stem cells reside in the ductal tissue of the pancreas. This study speaks directly to the ongoing controversy about the potential of people with T1 diabetes to regenerate lost insulin-secreting beta cells from progenitor cells. These new findings support previous evidence that adult human pancreatic duct cells possess endocrine differentiation potential and suggest that even adults with established T1 diabetes retain the potential for INGAP-induced regeneration of islets, which secrete insulin and other important hormones.
Combination of INGAP and an Immune Modulator Shows Full Remission of Type 1 Diabetes
A second study to be presented was conducted by Dr. Jerry Nadler and colleagues at the University of Virginia. A combination therapy regimen of Lisofylline (LSF), an immune modulator and INGAP Peptide was given to diabetic NOD mice. Two consecutive blood glucose measurements greater than 250mg/dl were required to demonstrate established T1 diabetes, and the mice were randomly placed into five treatment groups: 1) Saline, 2) LSF alone, 3) INGAP alone, 4) LSF+INGAP 5) Pretreatment with LSF followed by LSF+INGAP. Neither saline, LSF or INGAP alone reversed diabetes, but the combination of INGAP and LSF had remission rates of 70%. Histologic examination confirmed new islet formation. T1 diabetes is associated with loss of beta-cell mass resulting from an autoimmune response that destroys the islet cells. “The robust efficacy and response rate demonstrated by the combination of INGAP and LSF in this model is compelling,” stated Dr. Fleming. “The combination regimen likely addresses two of the important underlying causes of diabetes — the autoimmune attack and the loss of beta cells and insulin secretion — and may portend a durable therapeutic effect in patients.”
INGAP Clinical Development Resumes in 2008
KMI will conduct a clinical trial in Canada to test a refined formulation and delivery regimen of INGAP in T1 diabetes patients later this year through the generous donation from John and Pattie Cleghorn and MUHC’s Best Care for Life campaign.
About Kinexum Metabolics, Inc.
Kinexum Metabolics, Inc. is a biopharmaceutical company focused on the development of therapies for the treatment of Type 1 and Type 2 diabetes and other metabolic conditions.
Contacts: Media: Zoe Heineman Myers 202-415-6547 [email protected] Investors: Lisa Jansa 952-898-8914 [email protected]
SOURCE: Kinexum
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