WASHINGTON, DC -- (MARKET WIRE) -- 04/04/08 -- Kinexum Metabolics, Inc. (KMI) announced twoabstracts will be presented on INGAP Peptide at the Keystone Symposia onIslet and Beta Cell Biology to be held April 6-10, 2008. These two studiesdemonstrate important new data to advance the development of INGAP Peptideas a treatment to regenerate fully functioning islet cells that can restoreinsulin secretion for Type 1 diabetes patients. "We are encouraged bythese new studies and believe they demonstrate great potential for INGAPPeptide as a therapeutic approach for Type 1 diabetes and insulin-dependentType 2 diabetes," stated Dr. Alexander Fleming, founder and Chief MedicalOfficer of KMI and a well-known authority on metabolic drug development."These new data demonstrate for the first time induction of endocrine cellsfrom a human pancreatic ductal cell line in vitro and the use ofcombination therapy to induce islet regeneration and clinical remission ina 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 andcolleagues at McGill University Health Centre (MUHC). Adult humanpancreatic duct cells treated with INGAP Peptide for 24 hours resulted insubstantial increases in expression of insulin and PDX, an endocrine cellmarker. These results not only demonstrate INGAP's endocrine cell-inductionactivity in human tissue, they also suggest that islet progenitor or stemcells reside in the ductal tissue of the pancreas. This study speaksdirectly to the ongoing controversy about the potential of people with T1diabetes to regenerate lost insulin-secreting beta cells from progenitorcells. These new findings support previous evidence that adult humanpancreatic duct cells possess endocrine differentiation potential andsuggest that even adults with established T1 diabetes retain the potentialfor INGAP-induced regeneration of islets, which secrete insulin and otherimportant hormones.
Combination of INGAP and an Immune Modulator Shows Full Remission of Type 1Diabetes
A second study to be presented was conducted by Dr. Jerry Nadler andcolleagues at the University of Virginia. A combination therapy regimen ofLisofylline (LSF), an immune modulator and INGAP Peptide was given todiabetic NOD mice. Two consecutive blood glucose measurements greater than250mg/dl were required to demonstrate established T1 diabetes, and the micewere randomly placed into five treatment groups: 1) Saline, 2) LSF alone,3) INGAP alone, 4) LSF+INGAP 5) Pretreatment with LSF followed byLSF+INGAP. Neither saline, LSF or INGAP alone reversed diabetes, but thecombination of INGAP and LSF had remission rates of 70%. Histologicexamination confirmed new islet formation. T1 diabetes is associated withloss of beta-cell mass resulting from an autoimmune response that destroysthe islet cells. "The robust efficacy and response rate demonstrated bythe combination of INGAP and LSF in this model is compelling," stated Dr.Fleming. "The combination regimen likely addresses two of the importantunderlying causes of diabetes -- the autoimmune attack and the loss of betacells and insulin secretion -- and may portend a durable therapeutic effectin patients."
INGAP Clinical Development Resumes in 2008
KMI will conduct a clinical trial in Canada to test a refined formulationand delivery regimen of INGAP in T1 diabetes patients later this yearthrough the generous donation from John and Pattie Cleghorn and MUHC's BestCare for Life campaign.
About Kinexum Metabolics, Inc.
Kinexum Metabolics, Inc. is a biopharmaceutical company focused on thedevelopment of therapies for the treatment of Type 1 and Type 2 diabetesand other metabolic conditions.
Contacts:
Media:
Zoe Heineman Myers
202-415-6547
Zoe@kinexum.com
Investors:
Lisa Jansa
952-898-8914
LisaJansa@kinexum.com
