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Images from Before and After Treatment
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The slides depict a microscopic view of insulin-containing cells in an animal pancreas before and after the administration of INGAP. There are more insulin-positive cells in the INGAP-treated animal and they are brighter, which means they can produce larger quantities of insulin.
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December 17, 2001
NORFOLK, VA. -- A substance that encourages the growth of insulin-producing cells in the pancreas and has arrested diabetes mellitus in an animal model is now undergoing human testing in clinical trials at three sites in the United States.
This is the first clinical trial involving the INGAP (islet neogenesis gene associated protein) Peptide. It derives from discoveries made by Aaron I. Vinik, M.D., Ph.D., professor of medicine, pathology & neurobiology, and director of research at the Strelitz Diabetes Institutes at Eastern Virginia Medical School in Norfolk, Virginia, and Lawrence Rosenberg, M.D., Ph.D., professor of surgery and medicine, and director of the Division of Surgical Research at McGill University and the McGill University Health Center in Montreal, Canada.
GMP Companies, Inc., a privately held global healthcare company that seeks to develop and commercialize novel medical technologies, entered a licensing and research funding agreement with EVMS January 31, 2000, to help accelerate the INGAP work. The research funding agreement provided substantial funding over a five-year period.
Vinik and Rosenberg found that administration of the INGAP Peptide to certain species of diabetic animals increased insulin levels and lowered blood glucose levels.
"INGAP Peptide represents a potential anti-diabetic therapy directed at the basis of the disease," Vinik said. "It stimulates the growth of insulin-producing cells in neoislets in the pancreas, rather than treating the metabolic consequences of diabetes such as high blood sugar."
The researchers identified INGAP as a naturally occurring protein product that is associated with the generation of islets of Langerhans during normal development of the pancreas. Islets of Langerhans are areas within the pancreas that produce hormones, including insulin and glucagon, which
are largely responsible for keeping the blood glucose concentration within the normal range. Diabetes is a common disease that affects more than 16 million people in the United States and 130 million people worldwide.
Vinik and Rosenberg later identified the smaller, active portion of the INGAP protein, which was isolated and termed INGAP Peptide.
The Phase 1 / 2a clinical study will assess the safety and tolerability of single and multiple doses of INGAP Peptide in patients with type 1 and type 2 diabetes mellitus.
The trial is being conducted by three leading diabetes specialists at three study sites in the United States: Ralph A. DeFronzo, M.D., Texas Diabetes Institute/The University of Texas in San Antonio; John B. Buse, M.D., Ph.D., Diabetes Care Center / The University of North Carolina at Chapel Hill; and Robert E. Ratner, M.D., MedStar Research Institute in Washington, D.C.
If INGAP proves safe and tolerable during the initial trial, additional clinical studies involving a larger number of people may be conducted to study its effectiveness.
The start of clinical trials comes after decades of research. Many years ago, Vinik's research was considered too "avant garde" to attract research support, said Leon Paul Georges, M.D., professor and chairman of internal medicine and director of the Strelitz Diabetes Institutes at EVMS.
Georges recruited Vinik to Norfolk from the University of Michigan. Georges was impressed by the logical progression of Vinik's research, though he knew it would take many years to reach fruition.
"I'm incredibly enthusiastic," Georges said of the start of clinical trials. "I've been a believer and I remain a believer" in INGAP's potential.
"We believe that INGAP Peptide has the potential to be an important approach in the treatment of patients with diabetes mellitus," said Bart Chernow, M.D., president and CEO of GMP Companies, Inc. "As an endocrinologist who has seen many patients suffer from diabetes, I am hopeful that the treatment proves to be safe and efficacious so that we can help patients."
According to Michael Salem, M.D., executive vice president of research & development for GMP Companies, Inc., "the start of these initial clinical trials is an important first step in evaluating a potentially exciting treatment for the many patients worldwide suffering with diabetes. Since INGAP Peptide may stimulate new islet formation with the corresponding production of insulin, many diabetic patients may possibly benefit from this treatment approach." |
