REYKJAVIK, Iceland, June 30 /PRNewswire-FirstCall/ -- deCODE genetics (Nasdaq: DCGN) today announced positive topline results from its latest clinical pharmacology study of DG041, the company's first-in-class antagonist of the EP3 receptor for prostaglandin E2, developed as a next-generation oral anti-platelet therapy for preventing arterial thrombosis without increasing bleeding risk. The prospective, randomized, blinded, crossover study compared the effects on platelet activation and bleeding time of DG041 alone and in combination with the mainstays of current antiplatelet treatment, Plavix(TM) (clopidogrel) and aspirin. The results confirm previous clinical findings that DG041 inhibits platelet aggregation without increasing bleeding time as monotherapy, and further demonstrated that in combination with clopidogrel alone, as well as with clopidogrel and aspirin, DG041 provided additional antiplatelet effect without prolonging bleeding time.
deCODE's product development team will discuss the results of this study in detail at the company's annual R&D event to be webcast live today beginning at 1pm Eastern Time through the investor's page of the company's website, http://www.decode.com.
"These findings underscore the potential of DG041 as a next-generation oral anti-platelet: a compound that can reduce the risk of thrombi formation without increasing overall bleeding risk. While the current standard of care, clopidogrel and aspirin, has been shown to be effective in decreasing the risk of blood clots leading to heart attack and stroke, they do so in an untargeted manner and thus raise the likelihood of unwanted bleeding. By targeting EP3, which we identified through our human genetics work in peripheral artery disease, stroke and heart attack, DG041 has been shown to offer a novel approach to inhibiting platelet aggregation where it is needed -- at the site of lesions in the vasculature. One of the most compelling results coming out of this study is that DG041 was shown to substantially inhibit EP3 mediated platelet activation that is not being addressed by current therapy. This suggests that DG041 may have a favourable profile not only as a first-line therapy, but also as a combination therapy with existing standard of care. We are encouraged by these results and look forward to advancing DG041 into later stage trials with a strategic partner," said Kari Stefansson, CEO of deCODE.
deCODE's medicinal chemistry group discovered DG041 as a means to prevent arterial thrombosis by inhibiting the activity of EP3. In Phase I and Phase IIa clinical trials and follow-on clinical pharmacology studies, DG041 has been shown to dramatically inhibit platelet aggregation as well as platelet activation mediated specifically through vasodilator-stimulated phosphoprotein (VASP), a biomarker useful for measuring platelet activity. Following deCODE's gene discovery work linking this pathway with arterial disease, work by leading international scientists demonstrated in mice that PGE2 is produced in atherosclerotic plaques, promoting the formation of clots immediately at the sites of plaque but not over normal blood vessels. The formation of these thrombi is dependent on signaling through EP3. This pathway is left largely unaffected by existing anti-platelet drugs such as aspirin and Plavix(TM). deCODE is actively pursuing partnership opportunities for the latter phases of the clinical development of DG041.
deCODE is a biopharmaceutical company applying its discoveries in human genetics to the development of diagnostics and drugs for common diseases. deCODE is a global leader in gene discovery - our population approach and resources have enabled us to isolate key genes contributing to major public health challenges from cardiovascular disease to cancer, genes that are providing us with drug targets rooted in the basic biology of disease. Through its CLIA-registered laboratory, deCODE is offering a growing range of DNA- based tests for gauging risk and empowering prevention of common diseases, including deCODE T2(TM) for type 2 diabetes; deCODE AF(TM) for atrial fibrillation and stroke; deCODE MI(TM) for heart attack; deCODE ProCa(TM) for prostate cancer; and deCODE Glaucoma(TM) for risk of exfoliation glaucoma. deCODE is delivering on the promise of the new genetics(SM). Visit us on the web at http://www.decode.com; on our diagnostics website at http://www.decodediagnostics.com; and, for our pioneering personal genome analysis service, at http://www.decodeme.com.
Any statements contained in this presentation that relate to future
plans, events or performance are forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are subject to a number of risks and
uncertainties that could cause actual results, and the timing of events, to
differ materially from those described in the forward-looking statements.
These risks and uncertainties include, among others, those relating to our
ability to obtain financing and to form collaborative relationships,
uncertainty regarding potential future deterioration in the market for
auction rate securities which could result in additional permanent
impairment charges, our ability to develop and market diagnostic products,
the level of third party reimbursement for our products, risks related to
preclinical and clinical development of pharmaceutical products, including
the identification of compounds and the completion of clinical trials, the
effect of government regulation and the regulatory approval processes,
market acceptance, our ability to obtain and protect intellectual property
rights for our products, dependence on collaborative relationships, the
effect of competitive products, industry trends and other risks identified
in deCODE's filings with the Securities and Exchange Commission, including,
without limitation, the risk factors identified in our most recent Annual
Report on Form 10-K and any updates to those risk factors filed from time
to time in our Quarterly Reports on Form 10-Q or Current Reports on Form
8-K. deCODE undertakes no obligation to update or alter these
forward-looking statements as a result of new information, future events or
Edward Farmer Gisli Arnason Joy Bessenger
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|SOURCE deCODE genetics|
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