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Human clinical trials begin of potential novel treatment for diabetes

Posted: Friday, January 11, 2002

NORFOLK, Va. (AP) -- A substance that has cured diabetes in some laboratory animals is now being tested on people.

The INGAP -- Islets Neogenesis Associated Protein -- Peptide encourages the growth of insulin-producing cells in the pancreas. The body needs insulin to process sugar, and diabetes results from the inability to make or use insulin.

While the ultimate goal is to cure diabetes, INGAP has the potential to at least help diabetics manage their illness better, said Dr. Aaron I. Vinik, director of research at the Strelitz Diabetes Institutes at Eastern Virginia Medical School.

''It can change people's lives a huge amount if they don't have to take insulin anymore ... if they don't have to stick themselves seven to 10 times a day'' to test their blood sugar level, Vinik said.

The peptide derives from discoveries made by Vinik, professor of medicine, pathology and neurobiology at EVMS, and Dr. Lawrence Rosenberg, professor of surgery and medicine at McGill University in Montreal.

Vinik and Rosenberg found that injecting INGAP in certain species of diabetic animals increased insulin levels and lowered glucose levels. Some animals were cured 39 days after they began the therapy and had normal blood sugar levels even after stopping treatment for eight days, Vinik said.

An estimated 16 million Americans, and 130 million people worldwide, have diabetes. The disease requires patients to prick their fingers to check blood sugar levels several times a day and inject themselves with insulin or wear an abdominal insulin pump. It can cause nerve damage, blindness and kidney and heart failure.

It can also be fatal.

INGAP is a gene that encodes proteins that have the potential to produce cells capable of making the hormones necessary for keeping people's blood sugar levels normal, Vinik said. INGAP gets directly at the ''biological ineptitude'' of the pancreas while other drugs treat the symptoms and complications of diabetes, he said.

Vinik and Rosenberg identified the smaller, active portion of the INGAP protein, which was isolated and termed the INGAP Peptide. It can be synthesized in a test tube, Vinik said.

In July, the researchers applied to the U.S. Food and Drug Administration for permission to test the peptide on people. Approval was granted in September.

The study will assess the safety and tolerability of injections of various daily dosages of INGAP Peptide in 62 people. Participants must be insulin-dependent diabetics between 18 and 65 who are relatively healthy.

Three people began the injections in early December. More patients are needed for the trial being conducting by diabetes specialists at three study sites: the Texas Diabetes Institute at the University of Texas at San Antonio; the Diabetes Care Center at The University of North Carolina at Chapel Hill; and the MedStar Research Institute in Washington.

The trial should be finished by summer, Vinik said. If INGAP proves safe and tolerable, additional clinical studies involving more people would be needed to study its effectiveness.

The drug could be on the market within 10 years, said Scott Mohrland, vice president of the therapeutics division of GMP Companies Inc., a medical technology company in Fort Lauderdale, Fla., that has a licensing and funding agreement with EVMS to accelerate INGAP research.

''We're very cautiously optimistic and excited about the potential that this could have for patients suffering from this disease,'' he said.

Vinik is a respected diabetes researcher and his approach is novel, but it's too soon to tell whether this will work, cautioned Scott Campbell, vice president of research programs at the American Diabetes Association in Alexandria.

''We're looking forward to the next rounds (of tests) and hope this goes somewhere,'' he said.

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On the Net:

Eastern Virginia Medical School: http://www.evms.edu/about/news

GMP Companies Inc.: http://www.gmpcompanies.com

End advance for Monday, Jan. 14, and thereafter



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