Detailed account of the Abbas et.al presentation:
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Researcher From Emisphere Technologies Presents Oral Insulin Clinical Data At American Diabetes Association (ADA) 62nd Scientific Session
Oral Insulin Product Candidate Demonstrates Potential Benefits to Diabetics
SAN FRANCISCO, June 16 /PRNewswire-FirstCall/ -- At the American Diabetes Association (ADA) 62nd Scientific Session, held this week, a researcher from Emisphere Technologies, Inc. (Nasdaq: EMIS - News) today presented proof-of-concept clinical results from a study conducted at Medeval Limited in Manchester, United Kingdom, which showed that an oral formulation of insulin resulted in clinically significant absorption from the gastrointestinal tract. Data from the study confirms Emisphere's oral drug delivery technology is effective in orally delivering insulin because insulin when given orally cannot be absorbed into the bloodstream due in part to the relative large size of the molecule.
The data also demonstrated clinically significant reductions in blood glucose levels, consistent with reductions in glucose seen with injectable insulin. High blood glucose levels in diabetics may cause serious complications such as blindness, kidney disease, heart disease, stroke, neurological diseases, and amputations. The study demonstrated safety and tolerability and there were no serious adverse events.
The oral presentation was made today at The Moscone Center in San Francisco, CA in the session entitled, "Insulin: Alternative Administration Routes".
Orally delivered insulin is expected to have distinct advantages over systemic delivery options, because it is delivered directly to the portal vein and then to the liver, which is consistent with normal physiology and prevents residual insulin from lingering in the body. Excess insulin in the body is commonly associated with toxicity and other factors such as hypoglycemia.
It has been suggested by physicians specializing in the treatment of diabetes that an oral insulin product has the added potential to benefit diabetics currently using subcutaneous insulin since it offers greater convenience, no risk of injection related infections and/or needle stick injuries, and eliminates the pain and complications associated with injection. All of these benefits, should they be met, would aid in improving patient compliance.
The study's lead author, Richat Abbas, Ph.D., Director of Biopharmaceutics at Emisphere, who commented today stated at an ADA media briefing, "We are honored to present these data at an ADA Scientific Session, and to be considered among the leaders in the global effort to improve insulin delivery. We consider the data presented today to be very exciting because being able to deliver insulin to the liver first, before it reaches the systemic circulation, is consistent with normal physiology. Further, when the insulin is delivered with an EMISPHERE® delivery agent, it offers the same insulin that patients receive by injection and the same insulin that physicians have routinely prescribed to their patients for years. The Phase I data presented today is part of a growing clinical experience base that we are compiling with our oral insulin program."
Study Background
The double-blind, placebo-controlled study, conducted at Medeval Limited in Manchester, United Kingdom, consisted of the administration of insulin with an EMISPHERE® carrier in a capsule formulation to a total of 20 healthy human volunteers in the fasted state who received five different dose regimens, ranging from 100 to 150 units of insulin and 100 mg to 600 mg of carrier, and a subcutaneous control, with another two subjects who received placebo. Nine subjects received only the EMISPHERE® carrier.
In the study, researchers demonstrated insulin absorption from the gastrointestinal tract of clinically significant levels following oral dosing, with systemic concentrations reaching as high as 26.6uU/mL. The data also demonstrated a rapid drop in blood sugar following oral insulin administration, with mean reductions up to 23.7% as well as declines in mean C-Peptide levels up to 37.5%. In other studies for which the results were announced in September 2001, Emisphere reported absorption from the gastrointestinal tract with oral formulations of insulin as well as significant reductions in blood glucose levels with reductions up to 63%, and consistent compensatory declines in C-Peptide levels. The studies, presented on September 7, 2001 at an Emisphere sponsored investor day, dosed as high as 405 units of insulin. However, in the studies presented today, insulin was dosed at 100 to 150 uU/mL to avoid any hypoglycemic reactions (defined per protocol as blood glucose levels that dropped below 54 mg/dl).
The orally delivered insulin had favorable pharmacokinetic and pharmacodynamic profiles, in that systemic blood insulin levels peaked within 25 minutes. Such favorable profiles are considered to be significant by physicians, because the primary potential use of oral insulin would be before meals, and the more rapid the delivery, the better patients can time their medication to their meal.
In addition, data from studies conducted at the Hadassah Medical Center in Israel demonstrated the oral delivery of insulin using an EMISPHERE® carrier, and were presented at the Meeting as a poster, entitled, "A Novel Pre-Oral Insulin Formulation for Human Subjects." (Abstract no. 526-P)
Dr. Abbas concluded, "These data collectively provide proof-of-concept for Emisphere's oral drug delivery technology with insulin as evaluated in healthy, fasted volunteers. We are now in Phase II testing and conducting a clinical study focused on evaluating Type 2 diabetics under 'real life' conditions, after they have ingested a solid meal. In addition, we are planning to initiate a clinical study with Type 1 diabetics."
Diabetes Background
Diabetes is a disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches and other food into energy needed for daily life. Type 2 diabetes, previously known as adult-onset diabetes, is estimated to account for approximately 90-95% of all diagnosed cases. Type 1 diabetes, previously known as juvenile onset diabetes, is estimated to account for approximately 5-10% of all diagnosed cases.
Last year, diabetes affected approximately 17 million people in the United States and approximately 135 million people worldwide. The U.S. market for pharmaceuticals used to treat diabetes is estimated to exceed $6 billion, while the burden of treating the complications of diabetes is estimated to exceed $100 billon annually in the U.S. Emisphere plans to evaluate the use of oral insulin formulations in both Type 1 and Type 2 diabetics.
Medeval Background
Medeval Limited is a contract research organization dedicated to the early development of new medicines. With specific expertise in clinical pharmacology, pharmacokinetics and bioanalysis, Medeval works with most of the world's leading pharmaceutical and biotechnology companies. Based in Manchester, England, over 75% of Medeval's business originates from outside of the United Kingdom; an achievement that was recognized earlier this year by a Queen's Award for Enterprise: International Trade, bestowed by Queen Elizabeth II.
Emisphere Background
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. Seven Emisphere formulations are now in 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 Regarding Forward-Looking Statements
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 studies or clinical trials and any market that might develop for Emisphere's oral insulin product candidate, 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. 1-10615) filed on April 1, 2002.
For additional information, please visit Emisphere's web site at emisphere.com
Abstract is available on request.
Abstract #197-OR
"Oral Insulin: Pharmacokinetics and Pharmacodynamics of Human Insulin Following Oral Administration of an Insulin/Delivery Agent Capsule in Healthy
Volunteers"
Richat Abbas, Andrea Leone-Bay, Rajesh Agawal, Singai Majuri, Paul Rolan, Cyril Clarke, Colin Scott, Ehud Arbit, Robert Baughman. Paul Rolan and Cyril Clarke are from Medeval Limited, Manchester, UK. All other researchers were affiliated with Emisphere at the time of the study.
SOURCE: Emisphere Technologies, Inc. |
