Alternative delivery technologies (see also the "additional second study" in the PR)
SOURCE: Emisphere Technologies, Inc
Emisphere Oral Insulin Studies to be Presented at International Diabetes Technology Meeting
- Abstract Selected as 'One of The Best' Presented -
SAN FRANCISCO, Nov. 5 /PRNewswire/ -- Emisphere Technologies, Inc. (Nasdaq: EMIS - news) today announced that a study evaluating the oral delivery of insulin combined with one of the Company's proprietary delivery agents was selected as ``one of the best'' at the first international Diabetes Technology Meeting in San Francisco, CA (11/2/01-11/3/01). The study was selected by the meeting's Planning Committee, which is chaired by David Klonoff, M.D., Medical Director of Mills-Peninsula Diabetes Research Institute, San Mateo, CA.
The Phase I study, ``Pharmacokinetics of Human Insulin Delivered Orally in Healthy Volunteers,'' combining an EMISPHERE® carrier with insulin in an oral formulation demonstrated absorption from the gastrointestinal tract at clinically significant levels following oral dosing. The data, preliminarily presented at an Emisphere-sponsored Investor Day on September 7, 2001, demonstrated a rapid drop in blood sugar following oral insulin administration, with mean reductions in plasma glucose of approximately 30% at the highest insulin dose, as well as a consistent compensatory decline in C-peptide levels. In addition, it was demonstrated that the orally delivered insulin had favorable pharmacokinetic and pharmacodynamic profiles, in that systemic blood insulin levels peaked at less than 30 minutes, and the maximum drop in blood glucose levels were seen in under one hour after dosings. Further, the study demonstrated the tolerability of the combination, with no serious adverse events or drug related side effects in the study.
``It is a great honor, and a testament to the strength of Emisphere's oral insulin program, for this study to be selected as one of the best at the inaugural Diabetes Technology Meeting,'' said Richat Abbas, Ph.D., Director of Biopharmaceutics at Emisphere Technologies, Inc., and lead author of the study. ``Based partly on the positive results of this study, we have moved forward with dosing in Type II diabetic patients to determine additional pharmacokinetics, pharmacodynamics, and relative bioavailability of our oral insulin formulation.''
Additional Presentation
A second Emisphere study, presented by Cooper Woods, Ph.D., Department Head, Genomics, Emisphere Technologies, Inc., assessed the safety of pulmonary insulin in a rat model, utilizing gene micro-arrays to identify possible unforeseen effects. Following pulmonary administration of insulin, the study demonstrated an increase in the mRNA's encoding a number of markers of lung inflammation, which was not seen following subcutaneous insulin administration -- the standard route of administration. Of note, using Emisphere's proprietary delivery technology to enhance the pulmonary delivery of insulin, there was a significant decrease in markers of pulmonary inflammation. The study suggested that further investigation into the safety of pulmonary insulin was warranted.
Emisphere Technologies, Inc., is a biopharmaceutical company pioneering the oral delivery of otherwise injectable or inhaled drugs. By applying its unique carrier technology, Emisphere has taken a leadership position in solving the oral delivery of proteins, peptides and other macromolecules produced by both pharmaceutical and biotechnology companies. Six Emisphere formulations have advanced into clinical trials being conducted by Emisphere and its partners. Emisphere develops pharmaceutical products for its own portfolio and has several strategic alliances and ongoing feasibility studies with many of the world's leading pharmaceutical and biotechnology companies, including Novartis Pharma AG, Eli Lilly and Company, Regeneron Pharmaceuticals, Inc. and Cubist Pharmaceuticals, Inc.
Emisphere Safe Harbor Statement
The statements in this release and oral statements made by representatives of Emisphere relating to matters that are not historical facts (including without limitation those regarding the timing or potential outcomes of research collaborations or clinical trials and any market that might develop for Emisphere's oral insulin product or any of Emisphere's other product candidates) are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, the ability of Emisphere and/or its partners to develop, manufacture and commercialize products using Emisphere's drug delivery technology, Emisphere's ability to fund such efforts with or without partners, and other risks and uncertainties detailed in Emisphere's filings with the Securities and Exchange Commission, including those factors discussed under the caption ``Risk Factors'' in Emisphere's Annual Report on Form 10-K (file no. 001-10615) filed on October 25, 2000.
For additional information, please visit Emisphere's web site at
emisphere.com
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