CV Therapeutics: Dritter Medikamenten-Kandidat in Phase 3 - 500 Beiträge pro Seite

[Nachrichten [wO]]

Der Medikamentenkandidat CVT-510 aus dem Hause CV Therapeutics tritt in die Phase-3 der klinischen Erprobung ein. Der Wirkstoff soll zur Bekämpfung von Herzrhythmus-Störungen eingesetzt werden. Damit hat das Unternehmen drei Kandidaten in der abschließenden klinischen Testphase. Ranolazine, das am weitesten fortgeschrittene Produkt, soll bei der Behandlung von Angina Pectoris eingesetzt werden. CV Therapeutics ist eine Beteiligung im Portfolio von BB Biotech.

[gholzbauer]

Von wegen 3. Kandidat in Phase III ...
CVT-124 (gg. Congestive Heart Failure, CHF, an Biogen lizensiert) ist erst in Phase II; III folgt hoffentlich bald. Ranolazine ist in Phase III für chronische Angina und in Phase II für CHF. CVT-3146 wird erst in Phase II kommen.
Damit ist CVT-510 #2 in Phase III.

s. auch
http://www.prnewswire.com/gh/cnoc/comp/166425.html





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CV Therapeutics Initiates Phase III Clinical Trial of CVT-510




PALO ALTO, Calif., June 29 /PRNewswire/ --
CV Therapeutics, Inc. (Nasdaq: CVTX) today announced that it has initiated a
Phase III clinical trial of CVT-510, a selective A1 adenosine receptor
agonist, in patients with paroxysmal supraventricular tachycardia (PSVT).
CVT-510 is being developed for the potential reduction of rapid heart rate
during atrial arrhythmias.
"We are pleased with the progress that we have made with our CVT-510
program as we begin Phase III clinical trials," said Louis G. Lange, M.D.,
Ph.D., Chairman and Chief Executive Officer of CV Therapeutics, Inc. "CVT-510
now joins ranolazine as one of our two Phase III programs within our pipeline
of cardiovascular products."
The purpose of this Phase III, multi-center, randomized, double-blind,
placebo-controlled trial, is to determine the safety and efficacy of CVT-510
in the conversion of PSVT to normal sinus rhythm.
Atrial arrhythmias occur when electrical signals in the atria cause the
heart to beat too rapidly or uncontrollably. The most common atrial
arrhythmias are atrial fibrillation, atrial flutter, and PSVT.
The AV node controls the transmission of electrical impulses from the
atria to the ventricles. When the frequency of signals passing through the AV
node is too high, the ventricles, in turn, begin to beat too rapidly. The
resulting insufficient time for filling and emptying the left ventricle can
result in hypotension and reduced blood flow to the brain and other vital
organs. Therefore, the heart rate needs to be controlled immediately.
Since ventricular rate is determined by the speed at which electrical
impulses pass through the AV node, prompt slowing of AV nodal transmission can
reduce ventricular heart rate and improve cardiac output. Intravenous
therapies can allow for rapid stabilization of the patient while treating the
underlying condition.
Intravenous CVT-510 is designed to slow the speed of AV nodal conduction
by selectively stimulating the A1 adenosine receptor. Selective stimulation
of the A1 adenosine receptor avoids blood pressure lowering that can be caused
by stimulation of the A2 adenosine receptor. Since CVT-510 selectively
stimulates the A1 adenosine receptor without significantly stimulating the A2
adenosine receptor, it may be possible to use intravenous CVT-510 for rapid
intervention in the control of atrial arrhythmias without lowering blood
pressure.
CV Therapeutics, Inc., headquartered in Palo Alto, CA, is a
biopharmaceutical company focused on applying molecular cardiology to the
discovery, development and commercialization of novel, small molecule drugs
for the treatment of cardiovascular diseases. CVT currently has three
compounds in clinical trials. Ranolazine, the first in a new class of
compounds known as partial fatty acid oxidation (pFOX) inhibitors, is in Phase
III clinical trials for the potential treatment of chronic angina. CVT-510,
an A1 adenosine receptor agonist, is in Phase III clinical trials for the
potential reduction of rapid heart rate during atrial arrhythmias. CVT-3146,
an A2A adenosine receptor agonist, is in Phase I clinical trials for the
potential use as an adjunctive pharmacologic agent in cardiac perfusion
imaging studies. For more information, please visit CV Therapeutics` web site
at http://www.cvt.com .
Except for the historical information contained herein, the matters set
forth in this press release, including statements as to commercialization of
the company`s products, are forward-looking statements within the meaning of
the "safe harbor" provisions of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially, including,
early stage of development; the timing of clinical trials; the dependence on
collaborative and licensing agreements; and other risks detailed from time to
time in CVT`s SEC reports, including its Annual Report on Form 10-K for the
year ended December 31, 2000. CVT disclaims any intent or obligation to
update these forward-looking statements.

[script]

wird ranozaline auch gegen chf getestet? ich aber das so verstanden, dass die nebenwirkungen bei patienten die angina und chf haben getestet werden sollen.

[script]

CV Therapeutics, Inc. (Nasdaq: CVTX) today announced the initiation of a
Phase II clinical trial of ranolazine in patients with congestive heart
failure (CHF). Ranolazine is the first of a new class of investigational
drugs known as pFOX (partial Fatty Acid Oxidation) inhibitors.
CV Therapeutics is currently conducting a second Phase III clinical trial with
ranolazine, in patients with chronic angina, called CARISA (Combination
Assessment of Ranolazine In Stable Angina) to examine the safety and
effectiveness of the drug when compared to placebo, in combination with other
anti-anginal medications.
"We are excited to begin our evaluation of the safety and tolerability of
ranolazine in patients with CHF, a disease affecting more than four million
people in the U.S.," said Louis G. Lange, M.D., Ph.D., Chairman and
Chief Executive Officer of CV Therapeutics. "Because CHF afflicts
approximately one quarter of chronic angina patients, the results from this
study can be used to support an NDA for ranolazine in chronic angina. In
addition, we will evaluate pilot efficacy endpoints in CHF, which will guide
us on how to study ranolazine for the treatment of CHF in the future."

[gholzbauer]

Hallo script,
primäres Ziel ist wohl, die Sicherheit von Ranolazine bei Patienten, die neben Angina noch CHF haben, nachzuweisen. Offenbar wirkt Ranolazine aber auch direkt positiv auf CHF, siehe auch die Fortsetzung des Textes:

"...This multicenter Phase II clinical trial is a randomized, double-blind,
placebo-controlled trial of orally administered ranolazine in patients with
New York Heart Association Class III and IV CHF. The study evaluates the
pharmacokinetics, safety and tolerability of ranolazine in patients with
severe CHF.

Rationale for Ranolazine in CHF: Pre-clinical data
In November 2000, CVT and its collaborators were judged to have presented
the "Best Overall" Heart Failure poster at Scientific Sessions 2000 of the
American Heart Association. In this pre-clinical study, animals with
experimentally-induced CHF were compared to normal, non-affected animals to
evaluate the potential use of ranolazine for the acute treatment of CHF.
Within 30 minutes of an intravenous infusion of ranolazine, global left
ventricular function increased in animals with CHF, as evidenced by an
increase in left ventricular ejection fraction and stroke volume (p<0.001),
without significant effects on blood pressure or heart rate. In contrast,
ranolazine did not have any effects on left ventricular function, nor on blood
pressure or heart rate, in normal animals. These data were interpreted to
suggest that a brief exposure of ranolazine increased the pumping function of
the failing hearts by increasing the efficiency of their energy use, rather
than by increasing their overall energy expenditures. The poster will be
published in an upcoming issue of the American Heart Association`s journal,
Circulation: Journal of the American Heart Association.
CHF occurs when the heart muscle is weakened by disease so it cannot
adequately pump blood throughout the body. As a result of this pump failure,
fluid accumulates throughout the body; in the lungs, this results in shortness
of breath. Approximately 4.6 million people in the U.S. suffer from CHF, with
an estimated 400,000 new cases each year. CHF is the leading cause of
hospitalizations for people age 65 and over. In addition, the five-year
mortality rate for CHF is approximately 50%.
..."

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=105&STORY=…




Für mich als Laien klingt es plausibel, daß Ranolazine als herzleistungserhöhendes Medikament auch bei CHF wirkt. ("CHF occurs when the heart muscle is weakened by disease so it cannot
adequately pump blood throughout the body.")

Das Zeug müßte man doch auch als Dopingmittel im Sport einsetzen können!?! Wird aber evtl. leicht nachzuweisen sein.