CV THERAPEUTICS UPDATES PROGRESS WITH TECADENOSON
PALO ALTO, CALIF., OCTOBER 22, 2002 -- CV Therapeutics, Inc. (Nasdaq: CVTX)
today announced that a Phase III clinical trial of tecadenoson (CVT-510) in
patients with paroxysmal supraventricular tachycardia (PSVT), an abnormally
rapid heart rhythm, met its primary endpoint, which was the conversion of PSVT
to a normal, or sinus, heart rhythm without second or third degree
atrio-ventricular block. This Phase III, multi-center, randomized, double-blind,
placebo-controlled trial evaluated five doses of tecadenoson in 181 patients in
the electrophysiology laboratory. The company plans to present detailed data
from this trial at an upcoming medical conference.
CV Therapeutics has been investigating tecadenoson in a Phase IIb program for
use in patients with atrial fibrillation or atrial flutter. The company intends
to continue conducting additional studies to identify an appropriate potential
commercial dosing regimen for tecadenoson in individuals with atrial
fibrillation or atrial flutter.
Tecadenoson is a novel compound that selectively stimulates the A1 adenosine
receptor. Stimulation of the A1 adenosine receptor slows the conduction of
electrical impulses in the AV node of the heart, a region that controls the
transmission of electrical impulses from the atria to the ventricles. Adenosine
is a naturally occurring compound that stimulates all adenosine receptor
subtypes in the body, including the A2 adenosine receptor which lowers blood
pressure. In non-clinical trials, tecadenoson selectively stimulated the A1
adenosine receptor in the AV node and slowed the speed of electrical conduction
across the AV node, reducing the number of electrical impulses that reached the
ventricle, without affecting blood pressure. Clinical studies to date with
intravenous tecadenoson suggest that it may slow the speed of AV nodal
conduction by selectively stimulating the A1 adenosine receptor, and may avoid
blood pressure lowering by not stimulating the A2 adenosine receptor. Thus, it
may be possible to use intravenous tecadenoson to convert patients from PSVT to
normal sinus rhythm without lowering blood pressure or causing adverse events
related to vasodilitation such as flushing, palpitations or headache.
Each year more than 2.5 million U.S. hospital admissions occur with patients who
report symptoms such as palpitations, chest pain and/or shortness of breath
caused by an atrial arrhythmia. Approximately 160,000 episodes of PSVT, which
can be precipitated by increased caffeine intake, stress or concurrent illness,
are treated every year in hospitals around the country.
In PSVT, atrial fibrillation and atrial flutter, excessive electrical activity
causes too many electrical impulses to reach the AV node. When the frequency of
electrical signals passing through the AV node is too high, the ventricles, in
turn, begin to beat too rapidly. This results in insufficient time for filling
and
emptying the left ventricle, which causes low blood pressure and reduced blood
flow to the brain and other vital organs.
Tecadenoson has not been approved for marketing by the Food and Drug
Administration (FDA) or other foreign regulatory agencies. Tecadenoson presently
is being investigated under a United States IND and applicable foreign
regulatory filings. CV Therapeutics has not submitted a new drug application to
the FDA or an equivalent application to any other foreign regulatory agency for
tecadenoson, and tecadenoson has not been determined to be safe or effective in
humans for its intended uses. |
