Emisphere Technologies, Inc. today announced results of a clinical study designed to compare heparin administered in the company's proprietary oral formulation to heparin administered by the two standard methods of injection. The purpose of the study was to demonstrate that heparin's molecular configuration when delivered by the oral route using the Emisphere's eligen technology is unaltered as compared to heparin when administered by either the subcutaneous or intravenous routes of administration. The results show that heparin delivered orally utilizing Emisphere's eligen drug delivery technology, is chemically identical to heparin delivered by injection. The study was conducted as a result of discussions with the U.S. Food and Drug Administration ("FDA") regarding potential expedited registration pathways for oral heparin.
Previous studies have repeatedly demonstrated that Emisphere's oral heparin formulation can elevate the key parameters of anticoagulation (aptt, anti-Factor Xa, Anti-Factor IIa and TFPI) similar to injectable heparin. The data from the recently completed study is expected to support a claim that heparin is unchanged by the oral route of administration using Emisphere's eligen® technology.
"Our data confirms that the eligen technology makes it possible to deliver heparin to the blood stream in an oral formulation," commented Robert J. Linhardt, Ph.D., professor of chemistry and chemical biology at the Rensselaer Polytechnic Institute. "The data show that heparin delivered to the blood in an oral formulation has the same molecular properties as native heparin (naturally occurring heparin) and heparin delivered by injection. We look forward to submitting these results to peer reviewed publications with additional data in the near term."
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