Emisphere Technologies Inc. said it has started a Europeanclinical study of its proprietary oral delivery system (ODS)using a low molecular weight heparin.
The study is intended to demonstrate the safety of the ODS,which Emisphere sees as a potential means for administeringlarge-molecule compounds, such as proteins, to thebloodstream. "We want to demonstrate a correlation betweenhuman and primate data," said Michael M. Goldberg,Emisphere's president and chief executive officer.
Emisphere (NASDAQ:EMIS) of Hawthorne, N.Y., reported in lateJuly to the Controlled Release Society meeting that it hadsuccessfully administered an active monoclonal antibody(MAb) into the bloodstreams of rats by placing the ODS-encapsulated MAb in the animals' stomachs.
Animal tests of the ODS showed that raising the dose levels ofthe encapsulated compounds could achieve a level of biologicalactivity comparable to intravenous delivery, the company said.
The new study, at an undisclosed site, will involve about 10healthy people in a dose-escalating trial, Goldberg said.Participants will be removed from the study as heparin reachesa clinically significant level in their bloodstreams. Heparin of alow molecular weight was chosen because it shows lessvariability in individual responses.
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