TARRYTOWN, N.Y., April 11 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. today announced it has completed enrollment of the first 120 patients in its Phase II oral insulin clinical trial (the "Trial"), and has received permission from regulatory authorities in India to expand the Trial enrollment from 120 patients to 140 patients. By expanding the Trial, Emisphere will be able to evaluate the performance of all three active arms of the Trial against each other for statistical significance. Without the additional patients, Emisphere would have been limited to evaluating each of the active arms against only the placebo for statistical significance. Based on the current enrollment rate, the Company expects to complete the additional enrollment within the next few weeks.
"Expanding our trial enrollment will give us a more robust data set to compare the three different dosing regimens of oral insulin being tested in this Trial," commented Michael M. Goldberg, M.D., Chairman and Chief Executive Officer of Emisphere Technologies. "We are pleased with the safety and activities observed to date, and are delighted that the DCGI granted us permission to increase enrollment. We expect to complete the Trial, and look forward to un-blinding and reporting the results during the second half of this year."
Emisphere is closely monitoring the blinded data received from the Trial, and as of April 1, fifty nine (59) patients have had their 30-day visit, twenty two (22) patients have had their 60-day visit, and a small number of patients have completed the end of study 90-day visit. The Company is encouraged by the meaningful number of patients showing a greater than one percent drop in their hemoglobin A1c (HbA1c) at 60 days. In addition, these patients are not showing weight gain, which is very commonly seen with insulin treatment. There have been no reported cases of treatment-related serious adverse events or hypoglycemia. Hypoglycemia is also very commonly observed in diabetic patients treated with insulin, and as a result, insulin therapy requires patients to frequently monitor their blood sugar and adjust their insulin therapy accordingly. One of the primary objectives of the Trial is to test the hypothesis that oral insulin can be administered as a fixed dose without the need to frequently monitor the patients' blood.
In November 2005, Emisphere commenced enrollment for the 90-day, multi-center, randomized Trial. The four-arm study will evaluate the safety and efficacy of low and high fixed doses of oral insulin tablets versus placebo in 120 patients with Type 2 Diabetes Mellitus who have inadequate glycemic control with their existing oral metformin monotherapy. The primary efficacy endpoint of the Trial is related to the change in HbA1c, the standard for evaluating glucose control in Type II diabetics. Emisphere also will focus on the safety of oral insulin, specifically incidents of hypoglycemia, as well as the occurrence of insulin antibodies.
About Emisphere Technologies, Inc.
Emisphere Technologies, Inc. is a biopharmaceutical company pioneering the oral delivery of otherwise injectable drugs. Emisphere's business strategy is to develop oral forms of injectable drugs that are not currently available or have poor bioavailability in oral form, either alone or with corporate partners, by applying its proprietary eligen(R) technology to those drugs or licensing its eligen(R) technology to partners who typically apply it directly to their marketed drugs. Emisphere's eligen(R) technology enables the oral delivery of proteins, peptides, macromolecules and charged organics. Emisphere and its partners have advanced oral formulations or prototypes of salmon calcitonin, heparin, insulin, parathyroid hormone, human growth hormone and cromolyn sodium into clinical trials. Emisphere has strategic alliances with world-leading pharmaceutical companies. For further information, please visit http://www.emisphere.com .
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 collaborations or clinical trials, any market that might develop for any of Emisphere's product candidates and the sufficiency of Emisphere's cash and other capital resources) 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 (the "SEC"), including those factors discussed under the caption "Risk Factors" in Emisphere's Annual Report on Form 10-K (file no. 1-10615) filed on March 16, 2006.
Emisphere Technologies, Inc.CONTACT: Elliot M. Maza, CPA, J.D., Chief Financial Officer,+1-914-785-4703, or Stewart Siskind, Investor Relations, +1-914-785-4790,info@emisphere.com, both Emisphere Technologies, Inc.; or Dan Budwick ofBMC Communications, +1-212-477-9007 ext. 14, Media Relations for EmisphereTechnologies, Inc.
Web site: http://www.emisphere.com/
