REYKJAVIK, Iceland, June 30 deCODE genetics(Nasdaq: DCGN) today announced positive topline results from its latestclinical pharmacology study of DG041, the company's first-in-class antagonistof the EP3 receptor for prostaglandin E2, developed as a next-generation oralanti-platelet therapy for preventing arterial thrombosis without increasingbleeding risk. The prospective, randomized, blinded, crossover study comparedthe effects on platelet activation and bleeding time of DG041 alone and incombination with the mainstays of current antiplatelet treatment, Plavix(TM)(clopidogrel) and aspirin. The results confirm previous clinical findings thatDG041 inhibits platelet aggregation without increasing bleeding time asmonotherapy, and further demonstrated that in combination with clopidogrelalone, as well as with clopidogrel and aspirin, DG041 provided additionalantiplatelet effect without prolonging bleeding time.
deCODE's product development team will discuss the results of this studyin detail at the company's annual R&D event to be webcast live today beginningat 1pm Eastern Time through the investor's page of the company's website,www.decode.com.
"These findings underscore the potential of DG041 as a next-generationoral anti-platelet: a compound that can reduce the risk of thrombi formationwithout increasing overall bleeding risk. While the current standard of care,clopidogrel and aspirin, has been shown to be effective in decreasing the riskof blood clots leading to heart attack and stroke, they do so in an untargetedmanner and thus raise the likelihood of unwanted bleeding. By targeting EP3,which we identified through our human genetics work in peripheral arterydisease, stroke and heart attack, DG041 has been shown to offer a novelapproach to inhibiting platelet aggregation where it is needed -- at the siteof lesions in the vasculature. One of the most compelling results coming outof this study is that DG041 was shown to substantially inhibit EP3 mediatedplatelet activation that is not being addressed by current therapy. Thissuggests that DG041 may have a favourable profile not only as a first-linetherapy, but also as a combination therapy with existing standard of care. Weare encouraged by these results and look forward to advancing DG041 into laterstage trials with a strategic partner," said Kari Stefansson, CEO of deCODE.
deCODE's medicinal chemistry group discovered DG041 as a means to preventarterial thrombosis by inhibiting the activity of EP3. In Phase I and PhaseIIa clinical trials and follow-on clinical pharmacology studies, DG041 hasbeen shown to dramatically inhibit platelet aggregation as well as plateletactivation mediated specifically through vasodilator-stimulated phosphoprotein(VASP), a biomarker useful for measuring platelet activity. Following deCODE'sgene discovery work linking this pathway with arterial disease, work byleading international scientists demonstrated in mice that PGE2 is produced inatherosclerotic plaques, promoting the formation of clots immediately at thesites of plaque but not over normal blood vessels. The formation of thesethrombi is dependent on signaling through EP3. This pathway is left largelyunaffected by existing anti-platelet drugs such as aspirin and Plavix(TM).deCODE is actively pursuing partnership opportunities for the latter phases ofthe clinical development of DG041.
deCODE is a biopharmaceutical company applying its discoveries in humangenetics to the development of diagnostics and drugs for common diseases.deCODE is a global leader in gene discovery - our population approach andresources have enabled us to isolate key genes contributing to major publichealth challenges from cardiovascular disease to cancer, genes that areproviding us with drug targets rooted in the basic biology of disease. Throughits CLIA-registered laboratory, deCODE is offeri