No Safety Concerns Raised to Date on Oral Insulin Product
Company Receives Approval to Expand Study from 120 to 140 Patients
TARRYTOWN, N.Y., April 11 /PRNewswire-FirstCall/ -- Emisphere
Technologies, Inc. (Nasdaq: EMIS) 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.
SOURCE Emisphere Technologies, Inc.
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Related links:
http://www.emisphere.com
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 of BMC Communications, +1-212-477-9007 ext.
14, Media Relations for Emisphere Technologies, Inc.
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