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.
About DG041
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.
About deCODE
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
otherwise.
Contacts:
Edward Farmer Gisli Arnason Joy Bessenger
+1 212 343 2819 +354 570 1825 +1 212 481 3891
edward.farmer@decode.is gisli.arnason@decode.is joy.bessenger@decode.is
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[Via Healthcare]
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