Background Overview
«Recombinant Human Growth Hormone (hGH) with Extended Half-Life»
«Type 2 Diabetes Mellitus»
«Aging»
hGH with Extended Half-Life
hGH was introduced into
the market in 1985. It was originally approved for GH deficient (D) children. Since that time, hGH has been
approved for several conditions including: adult GHD, Turner syndrome, chronic renal
insufficiency, small for gestational age or intrauterine growth retarded children, Prader-Willi syndrome, and
continued height deficit individuals at puberty. Since 1985, thousands of children with growth failure due to
GHD have been treated with hGH replacement therapy and have achieved positive outcomes. hGH is
given daily to these individuals and is deemed to be safe and efficacious. However, with daily injections
come the problem of compliance; for instance, nearly half of the pediatric patients fail to comply with the treatment
plan. In order to simplify the dosing schedule, hGH with longer half life would be convenient and valuable.
Methods for the production of long acting hGH included Pegylation and generation of sustained release
formulations. Pegylation technology is rather expensive and relatively low yields of the final product are
recovered, relative to hGH produced and purified directly from the host expression system. No long acting version
of hGH is currently in use.
We have licensed from Ohio University long acting hGH O-linked glycosylation
(g) technology and are currently modifying the technology to produce new long acting hGH therapeutics. The
molecule is produced in cultured plant cells and the g-hGH is purified directly from the
culture media. The half life of the g-hGH molecule is considerably longer than hGH, and the ability to
stimulate IGF-1 production in vivo is equally enhanced.
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Diabetes, Obesity and Aging
Type 2 Diabetes Mellitus
Diabetes mellitus is a disorder characterized by elevated blood glucose (hyperglycemia). Type 1 diabetes
(insulin dependent diabetes mellitus) is characterized by a deficiency of insulin due to the autoimmune destruction
of the insulin-producing pancreatic ß-cells. Type 1 diabetes is relatively rare, affecting roughly 1 million
individuals in the USA.
In contrast, Type 2 diabetes is extremely prevalent; it affects approximately 16 million individuals in the United States and is predicted to affect 300 million people worldwide by 2025. Type 2 diabetes is characterized by insulin resistance, impaired glucose-stimulated insulin secretion, and ß-cell dysfunction. Although the pathogenesis of Type 2 diabetes is not completely understood, the relationship between obesity and the onset of Type 2 diabetes is intriguing.
DiAthegen is using mouse models of Type 1 and Type 2 diabetes to discover novel human therapeutics,
therapeutic targets, and diagnostics.
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Aging
It has been suggested that Type 2 diabetes may be, in part, associated with aging. DiAthegen has devoted a
portion of its research program toward understanding the molecular aspects of aging focusing on key organs and tissue.
Again, the goal is to discover therapeutics, therapeutic targets, and diagnostics that are specific for tissues
that show progressive decline as a function of age.