WORCESTER, Mass. and TORONTO, July 8, 2011 /PRNewswire/ —
Generex Biotechnology Corporation (OTC Bulletin Board:
GNBT) (www.generex.com) today announced
preliminary clinical results of two major trials using the Generex
Oral-lyn™ formulation that will be used for registration and
marketing. Unlike prior reported results from studies using
older versions of the formulation, the combined data from the now
completed 084 Trial in Type 1 patients and the Prevoral Trial in
patients with Impaired Glucose Tolerance provide key insights into
both the short-term pharmacokinetic and glucodynamic effectiveness
of Generex Oral-lyn™ in reducing post-prandial increases in
blood sugar as well as the long-term (one year) safety and positive
effect on metabolic control using the registration formulation of
Generex Oral-lyn™.
(Logo: http://photos.prnewswire.com/prnh/20110106/NY25057LOGO-b)
In the 084 Trial the final patient completed last visit in June
providing 463 type 1 diabetes patients completing the study.
The Prevoral trial had 31 patients with obesity and Impaired
Glucose Tolerance (a pre-diabetes syndrome) completing the
study.
Generex Oral-lyn™ was designed as a prandial (meal-time)
insulin to replace the failing rapid secretion of insulin, which a
healthy person’s insulin secreting cells in the pancreas normally
produce in response to eating a meal. While equally important
in both type 1 and type 2 diabetes patients, this rapid release of
insulin (first phase release) is one of the first abnormalities to
occur in type 2 patients and in those individuals with
pre-diabetes. The ability to reduce post meal hyperglycemia
by replacing this first phase insulin release is key to providing
glucose control in all patients
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