>>TARRYTOWN, N.Y., May 14 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. (Nasdaq: EMIS - News), today announced initial results from its Phase III study with an oral heparin formulation for the prevention of deep vein thrombosis (DVT, or blood clots) in total hip replacement surgery patients. The results did not demonstrate the superiority of oral heparin, when dosed in a 30-day treatment regimen, compared to Aventis' Lovenox® (enoxaparin) administered by injection in a 10-day dosing regimen in preventing DVTs.
"The rigorous study design of PROTECT sought at least an absolute 10% reduction in DVT events, to claim clinical superiority to the FDA," said Russell Hull, M.D., Director of the Thrombosis Research Unit, University of Calgary, Canada, PROTECT Steering Committee Chairman and the study's lead investigator for its North American study sites. "Data from the recently completed PROTECT study suggests that there was lower efficacy due to limitations related to the dosage form and that an improved formulation would result in higher patient compliance. While we are disappointed that we missed the anticipated primary endpoint, we are encouraged by the fact that orally administered heparin is clearly active and therefore a major advance in oral macromolecule delivery."
"We are disappointed that we did not meet the primary efficacy endpoint of the PROTECT Trial. Although we did not prove superiority of oral heparin compared to injected Lovenox, it was clear that with our carrier technology we were able to demonstrate the effectiveness of oral heparin in preventing deep vein thrombosis," said Michael M. Goldberg, M.D., Emisphere's Chairman and Chief Executive Officer. "While we acknowledge our disappointment with the results of the PROTECT study, we remain encouraged by the potential of our broadly applicable technology platform."
"Most importantly, this study reinforces the Emisphere technology for the oral delivery of macromolecules," stated Alan W. Dunton, M.D., President and Chief Operating Officer. "We will redefine our oral heparin program in the context of the performance of the product in the PROTECT study and remain committed to our other products currently in clinical development."
About PROTECT
The PROTECT Trial enrolled 2,288 patients to evaluate the safety and efficacy of oral heparin formulation using Emisphere's proprietary oral drug delivery technology for the prevention of DVT in total hip replacement surgery patients (a surgical patient population that historically has had the highest rate of these events). The goal of the PROTECT Trial was to demonstrate the superior efficacy and comparable safety of Emisphere's oral heparin when dosed postoperatively for a 30-day regimen, as compared to injectable enoxaparin, when dosed postoperatively for a 10-day regimen. (A 10-day regimen of injectable Lovenox is a standard of practice in the prevention of DVT, as determined by the American College of Chest Physicians' Sixth Consensus Conference.)
Study Design
The endpoint of PROTECT (Prophylaxis with Oral Heparin/Emisphere® SNAC against ThromboEmbolic Complications following Total Hip Replacement Surgery was DVT occurrence in the 30 days following surgery, or pulmonary embolism or death. Investigators at more than 120 sites, worldwide, evaluated a liquid form of heparin, consisting of the Emisphere® carrier, SNAC (Sodium N-[8-(2 hydroxybenzoyl)amino] caprylate) in combination with unfractionated heparin, when dosed orally in a 30-day regimen, compared to Lovenox (enoxaparin), when dosed subcutaneously (by injection) in a 10-day regimen. The study design was double-blind and double-dummy. Total DVTs were determined by bilateral venogram, the FDA standard for measurement, measured at 30 days following surgery. All venographies produced were read by radiologists at Boston's Massachusetts General Hospital to determine the presence of a blood clot (thrombus).<<
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