competitor starts Phase 1GMP Companies, Inc. Announces Start of Clinical Trials For Novel Treatment of Diabetes Mellitus
FORT LAUDERDALE, Florida, Dec. 17 /CNW/ - GMP Companies, Inc. (privately-
held), a global healthcare company that seeks to develop and commercialize
novel medical technologies, announced today the initiation of the first
clinical trial of INGAP Peptide for the treatment of patients with diabetes
mellitus.
INGAP Peptide derives from discoveries made by Aaron I. Vinik, M.D.,
Ph.D., Professor of Medicine, Anatomy & 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.
Drs. Vinik and Rosenberg found that administration of INGAP Peptide to
certain species of diabetic animals increases insulin levels and lowers blood
glucose levels. "INGAP Peptide represents a potentially novel anti-diabetic
therapy directed at the basis of the disease," said Dr. Vinik. "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." Dr. Rosenberg added, "Inducing the patient's own pancreas to regrow
new insulin-producing cells may well prevent the metabolic consequences in the
first place, or at least stabilize those that have already occurred."
They identified a naturally occurring protein product INGAP 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. In diabetes, the pancreas fails to make enough insulin to meet
the body's requirement. Diabetes is a common disease that affects more than 16
million people in the United States and 130 million people worldwide.
Drs. Vinik and Rosenberg named their discovery islet neogenesis gene
associated protein (INGAP). They later identified the smaller, active portion
of this 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 in Chapel Hill;
and, Robert E. Ratner, M.D., MedStar Research Institute in Washington, D.C.
"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." He added,
"Since INGAP Peptide may stimulate new islet formation with the corresponding
production of insulin, many diabetic patients may possibly benefit from this
treatment approach."
BACKGROUND ON GMP COMPANIES, INC.
---------------------------------
GMP Companies, Inc. is a global healthcare company headquartered in Fort
Lauderdale, Florida. The Company seeks to develop and commercialize novel
medical technologies. These technologies are typically licensed from academic
medical centers, individual inventors, research institutions and partner
companies. GMP Companies, Inc. has established 14 business units and is
organized in three divisions: Therapeutics, Diagnostics and Devices. These
divisions have products in various stages of development and commercialization
relating to the care of patients with medical conditions including diabetes
mellitus, cardiovascular diseases, neurological disorders, glaucoma and
genetic disorders. To learn more about the company or the diabetes clinical
trials, visit GMP's Web site at www.gmpcompanies.com.
The statements in this news release include statements which may
constitute forward-looking statements. Although GMP Companies, Inc. believes
the expectations contained in such forward-looking statements are reasonable,
it can give no assurance that such expectations will prove correct. These
statements may involve risks and uncertainties that could cause actual results
to differ materially from the expected results. Such risks include, but are
not limited to, the ability to obtain regulatory approval for and market
acceptance of products, the ability to effectively manage multiple
subsidiaries and diverse products, and the ability to manage growth.
For further information: MEDIA: Gisele Galoustian, (954) 745-3537;
INVESTORS: Brennen Arndt, (954) 745-3566