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The data were presented today at the American College of Cardiology 57thAnnual Scientific Session in Chicago by Arthur Moss, MD, professor of medicine(cardiology) and director of the heart research follow-up program at theUniversity of Rochester Medical School.
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"Since individuals with LQT3 syndrome have a defect in the specific sodiumchannel where ranolazine has its activity, it makes sense that we are seeingranolazine shorten the QT interval and improve cardiac relaxation in thesepatients," Moss said.
Five patients with LQT3 syndrome were prospectively investigated during aneight hour intravenous infusion of ranolazine, with ECG and ECHO evaluationbefore, during and after ranolazine administration.
In December 2007, the U.S. Food and Drug Administration approved newlanguage for the product labeling for Ranexa(R) (ranolazine extended-releasetablets) which describes the ability of ranolazine to inhibit the late sodiumcurrent at therapeutic levels.
Published data on ranolazine's mechanism of action suggests that duringischemic episodes excess sodium can flow into cardiac cells through sodiumchannels. This excess sodium can lead to calcium overload, which in turn canlead to impaired relaxation of the heart. Late sodium current inhibition hasbeen shown to improve mechanical and electrical dysfunctions of cardiac cellsunder these circumstances.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is abiopharmaceutical company focused on applying molecular cardiology to thediscovery, development and commercialization of novel, small molecule drugsfor the treatment of cardiovascular diseases.
CV Therapeutics' approved product, Ranexa(R) (ranolazine extended-releasetablets), is indicated for the treatment of chronic angina in patients whohave not achieved an adequate response with other antianginal drugs, andshould be used in combination with amlodipine, beta-blockers or nitrates.
CV Therapeutics also has other clinical and preclinical drug developmentcandidates and programs, including regadenoson, which is being developed forpotential use as a pharmacologic stress agent in myocardial perfusion imagingstudies. Regadenoson has not been determined by any regulatory authorities tobe safe or effective in humans for any use.
Except for the historical information contained herein, the matters setforth in this press release, including statements as to research anddevelopment and commercialization of products, are forward-looking statementswithin the meaning of the "safe harbor" provisions of the Private SecuritiesLitigation Reform Act of 1995. These forward-looking statements are subject torisks and uncertainties that may cause actual results to differ materially,including operating losses and fluctuations in operating results; capitalrequirements; regulatory review and approval of our products; special protocolassessment agreement; the conduct and timing of clinical trials;commercialization of products; market acceptance of products; productlabeling; concentrated customer base; reliance on strategic partnerships andcollaborations; uncertainties in drug development; uncertainties regardingintellectual property and other risks detailed from time to time in CVTherapeutics' SEC reports, including its Annual Report on Form 10-K for theyear ended December 31, 2007. CV Therapeutics disclaims any intent orobligation to update these forward-looking statements.
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