SBIR-STTR Award

Canine Studies To Restore Endogenous Insulin
Award last edited on: 4/15/10

Sponsored Program
SBIR
Awarding Agency
NIH : NIDDK
Total Award Amount
$277,416
Award Phase
1
Solicitation Topic Code
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Principal Investigator
B Brooke Ligon

Company Information

Mitokine Bioscience LLC

Po Box 275
Hancock, ME 04640
   (207) 422-6838
   bligon@mitokine.com
   www.mitokine.com
Location: Single
Congr. District: 02
County: Hancock

Phase I

Contract Number: 1R43DK079434-01A2
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2009
Phase I Amount
$277,416
Identifying a safe, oral treatment capable of both restoring the natural mechanisms that regenerate pancreatic beta cells and improving function would be a major advance in therapeutic options for diabetes. The objective of the proposed research is to test the hypothesis that oral administration of a natural beta cell product, that has been depleted by the disease, will result in improved beta cell function as measured by Cpeptide, fasting glucose, glycosylated hemoglobin and fructosamine. Twelve companion dogs that are naturally insulin-dependent will be studied in collaboration with the Clinical Sciences Department at Purdue University School of Veterinary Medicine. The aims of this research are 1) to test the feasibility and safety of this new diabetes therapy by measuring glycemic control before and after treatment and 2) test the pharmacokinetics of the treatment at various dosages. The long-term goal is to provide an oral product for both veterinary and human diabetes that offers sustained resolution of blood glucose abnormalities by restoring endogenous insulin without side effects or toxicity.

Public Health Relevance:
The proposed research will test the hypothesis that restoring a natural product of the cells that make insulin will improve their function and the symptoms of diabetes. The project will assess whether this treatment offers sustained improvement in glucose control without side effects or toxicity. If proven safe and effective, this treatment could be a major advance forward in therapeutic interventions for both type 1 and type 2 diabetes.

Public Health Relevance Statement:
Project Narrative The proposed research will test the hypothesis that restoring a natural product of the cells that make insulin will improve their function and the symptoms of diabetes. The project will assess whether this treatment offers sustained improvement in glucose control without side effects or toxicity. If proven safe and effective, this treatment could be a major advance forward in therapeutic interventions for both type 1 and type 2 diabetes.

NIH Spending Category:
Autoimmune Disease; Diabetes

Project Terms:
4-Aminobutanoic Acid; 4-Aminobutyric Acid; Administration, Oral; Adverse effects; After Care; After-Treatment; Aftercare; Aminalon; Aminalone; Aminobutyric Acids; Analysis, Data; Animals; Autoimmune Responses; Autoimmune Status; Autoimmunity; Beta Cell; Biological Factors; Blinded; Blood Glucose; Blood Plasma; Blood Sugar; Body Tissues; Body Weight; Butanoic acid, 4-amino-; C-Peptide; Canine Species; Canis familiaris; Cell Communication and Signaling; Cell Function; Cell Process; Cell Signaling; Cell division; Cell physiology; Cells; Cellular Function; Cellular Physiology; Cellular Process; Clinical Sciences; Collaborations; Companions; Connecting Peptide; D-Glucose; D-Isoglucosamine; Data; Data Analyses; Dextrose; Diabetes Mellitus; Disease; Disorder; Dogs; Dose; Drug Administration, Oral; Drug Kinetics; Enrollment; Factor, Biologic; Fasting; Fructosamine; GABA; Glucose; Glycated Hemoglobins; Glycosylated Hemoglobin; Goals; Hemoglobin, Glycosylated; Hour; Human; Human, General; Humulin R; Infiltration; Insulin; Insulin (ox), 8A-L-threonine-10A-L-isoleucine-30B-L-threonine-; Insulin Cell; Insulin Secreting Cell; Insulin, Regular; Intracellular Communication and Signaling; Kilogram; Life; Mammals, Dogs; Mammals, Rodents; Man (Taxonomy); Man, Modern; Masks; Measurement; Measures; Molecular; Mononuclear; Natural Products; Natural regeneration; Novolin R; Oral; Oral Administration; Outcome Measure; PBO; Pancreatic beta Cell; Pharmacokinetics; Phase; Placebos; Plasma; Proteins; Protocol; Protocols documentation; Regeneration; Research; Residual; Residual state; Resolution; Reticuloendothelial System, Serum, Plasma; Risk; Rodent; Rodent Model; Rodentia; Rodentias; Safety; Sampling; Schools; Schools, Veterinary; Serum, Plasma; Sham Treatment; Signal Transduction; Signal Transduction Systems; Signaling; Stimulus; Structure of beta Cell of islet; Subcellular Process; Symptoms; Syndrome; T-Cell Development; T-Cell Ontogeny; T-Cells; T-Lymphocyte; T-Lymphocyte Development; Testing; Therapeutic; Therapeutic Intervention; Thymus-Dependent Lymphocytes; Tissues; Toxic effect; Toxicities; Transplantation; Treatment Side Effects; Universities; Veterinarians; Veterinary Medicine; Veterinary Schools; Weight; biological signal transduction; blood glucose regulation; canine; diabetes; diabetes mellitus therapy; diabetes therapy; diabetic; disease/disorder; domestic dog; dosage; effective therapy; enroll; fasted; fasting glucose; fasts; functional restoration; gamma-Aminobutyric Acid; gene product; glucose control; glucose homeostasis; glucose meter; glucose monitor; glucose regulation; glycemic control; improved; improved functioning; intervention therapy; intraoral drug delivery; islet; pancreas beta cell; primary outcome; public health relevance; regenerate; restore function; restore functionality; restore lost function; secondary outcome; self recognition (immune); sham therapy; side effect; therapy adverse effect; thymus derived lymphocyte; transplant; treatment adverse effect; type I and type II diabetes

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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Phase II Amount
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