Conor Medsystems Initiates RAPID Clinical Study for First Pimecrolimus Drug-Eluting Stent
May 11 2006 - 10:12AM
PR Newswire (US)
Study to Evaluate Reduced Duration of Anti-Platelet Therapy
Following Stent Implantation MENLO PARK, Calif., May 11
/PRNewswire-FirstCall/ -- Conor Medsystems, Inc. (NASDAQ:CONR)
today announced that the company has initiated the RAPID (Reduced
Anti-platelet therapy with Pimecrolimus Drug-eluting stent)
clinical trial to evaluate the safety and efficacy of the company's
pimecrolimus-eluting cobalt chromium coronary stent system, known
as Corio(TM). The study will also evaluate a reduced duration of
post-procedure anti-platelet therapy. The Corio stent combines
Conor's novel reservoir-based stent platform with pimecrolimus for
the prevention of restenosis. Pimecrolimus, which was in-licensed
by Conor from Novartis Pharma AG in March 2006, is a cell-selective
inhibitor of the production and release of pro-inflammatory
cytokines. Inflammation is believed to be one of the key mechanisms
causing restenosis, or the excess proliferation of vascular smooth
muscle cells, as well as other vascular diseases such as unstable
plaques and diabetic lesions. Because pimecrolimus is not an
anti-mitotic compound, it is believed not to inhibit
re-endothelialization, or the growth of the endothelial cells that
line the interior surface and maintain the healthy functioning of
blood vessels. Following implantation of the Corio stent, the drug
is released and the polymer is absorbed after a number of months.
"Conor is committed to developing innovative drug-eluting stents
that improve patient outcomes," said Azin Parhizgar, Ph.D., Chief
Operating Officer of Conor. "The ability to potentially eliminate
months of post-procedure anti-platelet therapy would represent a
significant benefit to patients in terms of safety, convenience and
cost." "Conor's novel reservoir-based stent platform allows for the
complete delivery of the drug and the elimination of any polymer
residues; all that ultimately remains is a bare metal stent," said
Alexandre Abizaid, M.D., of the Institute Dante Pazzanese, Brazil,
and principal investigator for the study. "Conor's use of a polymer
that is absorbed by the body may reduce the incidence of late stent
thrombosis, a very serious complication that may be associated with
conventional surface-coated drug-eluting stents utilizing
non-bioresorbable polymers." The RAPID trial is a prospective, open
label, multi-center registry designed to enroll up to 150 patients
who, after implantation of the Corio stent, will receive two months
of aspirin and clopidogrel dual anti-platelet therapy. Thereafter,
the patients will be treated with aspirin only. All subjects will
undergo clinical follow-up at 30 days and coronary angiography at
six months, with clinical follow-up at 12 and 24 months. In
addition, a subset of 50 patients will also undergo intravascular
ultrasound (IVUS) evaluation at six months. The primary endpoint
for the RAPID study will be angiographic in-stent late loss at
six-month follow-up. Other endpoints include major adverse cardiac
events (MACE), target lesion revascularization (TLR), in-segment
and in-stent binary restenosis and in-segment late loss as measured
by angiography. The RAPID study is being conducted at up to 15
centers in Brazil and Europe. Data from the RAPID study will be
compared with historical controls from Arm 1 of Conor's EuroSTAR
study which evaluated the company's CoStar(TM) cobalt chromium
paclitaxel-eluting coronary stent system. Enrollment is anticipated
to be completed in the second half of this year, and the company
expects the initial results of the trial to be available in 2007.
In contrast to conventional surface-coated stents, Conor's stents
have been specifically designed for vascular drug delivery. The
company's stents incorporate hundreds of small holes, each acting
as a reservoir into which drug-polymer compositions can be loaded.
Through this reservoir design, Conor believes that it can greatly
enhance control over the rate and direction of drug release and
enable a wider range of drug therapies. In addition, Conor's cobalt
chromium drug-eluting stents use bioresorbable polymers that are
absorbed by the body after the drug is released, leaving no
permanent polymer residues at the target site. About Conor
Medsystems Conor Medsystems, Inc. develops innovative controlled
vascular drug delivery technologies, and has initially focused on
the development of drug eluting stents to treat coronary artery
disease. For further information on Conor Medsystems and controlled
vascular delivery, visit http://www.conormed.com/. Forward-looking
Statements Except for the historical information contained herein,
this press release contains certain forward-looking statements that
involve risks and uncertainties, including without limitation the
statements related to clinical development of the Corio stent. All
forward-looking statements and other information included in this
press release are based on information available to Conor
Medsystems as of the date hereof, and the company assumes no
obligation to update any such forward-looking statements or
information. The company's actual results could differ materially
from those described in the company's forward-looking statements.
Factors that could cause or contribute to such differences include,
but are not limited to, those discussed in detail under "Item 1A.
Risk Factors" in the company's Quarterly Report on Form 10-Q for
the quarter ended March 31, 2006, filed with the SEC on May 10,
2006, including (i) risks related to the uncertain, lengthy and
expensive clinical development process, including, among other
things, (a) the risk that the company's Corio stent, which is in
early stage clinical development, may not demonstrate safety or
efficacy in humans, (b) the risk that the RAPID trial may not be
completed on schedule, or at all, including as a result of patients
experiencing adverse side effects or events related to the Corio
stent which could result in termination of the trial, substantial
delays or a redesign of the trial, (c) the risk that the third
parties on whom the company relies to conduct its clinical trials
may not perform as contractually required or as expected, (d) the
risk that issues in the company's manufacturing processes could
delay or impede the company's clinical development plans, and (e)
the risk that clinical trial sites may decide to cease
participation in the RAPID trial; and (ii) risks related to patent
infringement, including, among other things, (a) the risk that if
any patent infringement claims or other intellectual property
claims against the company are successful, the company may, among
other things (1) be enjoined from, or required to cease, the
development, manufacture, use and sale of products that infringe
the patent rights of others, (2) be required to expend significant
resources to redesign its technology so that it does not infringe
others' patent rights, which may not be possible, and/or (3) be
required to obtain licenses to the infringed intellectual property,
which may not be available to the company on acceptable terms, or
at all, and (b) the risk that intellectual property litigation
against the company could significantly disrupt the company's
development and commercialization efforts, divert management's
attention and quickly consume the company's financial resources.
The risks and other factors discussed above should be considered
only in connection with the fully discussed risks and other factors
discussed in detail in the company's periodic reports filed with
the SEC, including the company's Quarterly Report on Form 10-Q for
the year ended March 31, 2006, filed with the SEC on May 10, 2006.
DATASOURCE: Conor Medsystems, Inc. CONTACT: investors, Michael
Boennighausen, Chief Financial Officer, of Conor Medsystems, Inc.,
+1-650-614-4100; or media, Karen L. Bergman, +1-650-575-1509, or
Nan Foster, +1-415-307-6955, both of BCC Partners, for Conor
Medsystems, Inc. Web site: http://www.conormed.com/
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