Posted by tim on April 29, 1998 at 19:10:52:
All right it's a slow day so I'll add this. While oral insulin "might" help compliance, it's only an adjustment. We need new tires and rims.
TORONTO, April 29 /CNW-PRN/ - Generex Biotechnology Corporation (the ``Company'')
(OTC-NASD Bulletin Board: ``GNBT'') announced today that it has completed additional human
clinical trials to evaluate ORALIN the Company's oral insulin formulation. The most recent studies,
involving seven healthy volunteers, were conducted earlier this month at the IEMIR-Instituto
Endocrinologia Metabolismo y Reproduccion, an endocrinology clinic located in Quito, Ecuador,
which has conducted numerous clinical trials for a variety of international pharmaceutical companies.
The protocol for these studies was discussed with representatives of the Food and Drug
Administration earlier this year, and was designed to provide proof of concept for (oral insulin
absorption) based upon the suppression of endogenous insulin secretion in healthy individuals, as
demonstrated by circulating C-peptide levels. In the studies, the administration of ORALIN resulted
in the suppression of C-peptide to levels that were intermediate between the effect of an oral
placebo and subcutaneously injected insulin.
Samples from this study also have been analyzed by the Banting and Best Diabetes Centre Core
Laboratory at the University of Toronto. The Banting and Best Laboratory analysis included
C-peptide, glucose and insulin assays, and results are being used in determining a long term research
plan currently being developed by Dr. Bernard Zinman, Professor of Medicine at the University of
Toronto and a Director of the Banting and Best Diabetes Centre. The Company expects this
research plan to serve as a platform for pivotal studies directed towards registration and approval of
ORALIN by the Food and Drug Administration in the United States, and by the Health Protection
Branch in Canada.
ORALIN is based upon a proprietary drug delivery platform technology developed by the
Company to orally administer pharmaceuticals which, historically, have been administered only by
needle. The trials completed by the Company this month were the latest of approximately 50 clinical
trials which the Company has conducted since 1994 to evaluate the efficacy and safety of ORALIN
in the treatment of diabetes. The subjects of these trials have included animals (rodents, dogs),
healthy volunteers and diabetic patients, and each trial provided encouraging evidence for the
glucodynamic activity of ORALIN. While its efforts to date have focused primarily on the research
and development of ORALIN, the Company has identified approximately 150 proteins, peptides,
monoclonal antibodies, hormones and vaccines that are candidates for oral administration using its
platform technology.