Bob from Houston.
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Forwarded message:
Subj: Emisphere Presents Oral Heparin Clinical Data and Oral Low Molecular
Weight Hepa
Date: 97-11-07 09:55:14 EST
From: AOL News
HAWTHORNE, N.Y., Nov. 7 /PRNewswire/ -- Emisphere Technologies, Inc.
(Nasdaq-NNM: EMIS) presented data from recent oral heparin studies, as well
as
other findings, at the Annual Meeting of the American Association of
Pharmaceutical Scientists in Boston, Massachusetts.
Oral Heparin Clinical Study. This poster presented the clinical
data from
Emisphere's second clinical study using an oral formulation of heparin USP.
As noted in a company press release dated July 14, 1997, the trial
demonstrated evidence of the oral delivery of clinically relevant levels of
heparin, as measured by blood clotting time (activated partial thromboplastin
time, or APTT) and anti-Factor Xa activity. Dose-dependent increases in
clotting times for the oral heparin were observed, and were well within the
therapeutic range for heparin. All formulations were well tolerated, and
none
of the subjects reported any treatment-related gastrointestinal effects or
other adverse experiences.
The trial consisted of five arms; four groups received a fixed
amount of
Emisphere's carrier and escalating doses of heparin ranging from 30,000 to
150,000 IU, administered as a drink in a 30 ml (two tablespoon) solution.
The
fifth group received a subcutaneous injection of heparin alone. In the
study,
a single oral dose of 2.25g of Emisphere's proprietary carrier SNAC
(sodium-N-amino caprylate, formerly designated E-414) in combination with
90,000 IU heparin produced a mean 50% increase in APTT and a mean peak
anti-Factor Xa of 0.17 IU/ml.
Oral Low Molecular Weight Heparin Primate Study. Emisphere
scientists
also presented data in which a low molecular weight heparin was orally
delivered to primates. The study employed two carriers: SNAC, and a new
carrier SNAD (sodium-N-amino decanoate).
Using SNAD, these data showed that low molecular weight heparin can
be
delivered orally in primates with a bioavailability of 38% relative to
subcutaneous injection. In addition, this oral formulation of low molecular
weight heparin was well tolerated by the primates. These studies showed SNAD
to be about four times more efficient than SNAC for oral heparin delivery.
Emisphere scientists also presented data from five other projects
including ongoing studies toward the development of oral recombinant human
growth hormone and oral vaccines.
Heparin, an anticoagulant, antithrombotic compound, is prescribed
for a
variety of cardiovascular indications. Current annual worldwide sales of
this
class of compounds, including heparin and low-molecular-weight heparins are
believed to exceed $1.5 billion.
Emisphere Technologies, Inc. is a drug delivery company focused on
the
discovery and application of proprietary synthetic chemical compounds that
enable the oral delivery of therapeutic macromolecules and other compounds
that are not currently deliverable by oral means. Emisphere has a joint
venture with Elan Corporation plc (NYSE: ELN) to develop oral formulations of
heparin products, and a strategic alliance with Eli Lilly & Co. (NYSE: LLY)
to
develop oral formulations of two therapeutic proteins in the area of
endocrinology. Further information about the Company can be found on the
Internet at www.emisphere.com.
The statements in this release relating to matters that are not
historical
facts are forward-looking statements that involve risks and uncertainties,
including, but not limited to, the ability of either Emisphere or its joint
venture with Elan to develop and commercialize an oral form of heparin and
other risks and uncertainties detailed in the Company's Securities and
Exchange Commission filings.
SOURCE Emisphere Technologies, Inc.
CO: Emisphere Technologies, Inc.; Elan Corporation; Eli Lilly & Co.
ST: New York
IN: MTC
SU:
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