Conor Medsystems Announces First Patient Treated with Dual-Drug Coronary Stent
May 18 2006 - 10:10AM
PR Newswire (US)
GENESIS Study to Compare New Corio(TM) and SymBio(TM) Stents to
CoStar(TM) Stent MENLO PARK, Calif., May 18 /PRNewswire-FirstCall/
-- Conor Medsystems, Inc. (NASDAQ:CONR) today announced that the
first patient has been treated with the company's novel dual-drug
coronary stent, SymBio(TM), as a special use lead-in case to the
initiation of the company's GENESIS clinical trial. The GENESIS
trial will be a randomized, multi-center study comparing the safety
and efficacy of Conor's two new drug-eluting coronary stents to its
CoStar(TM) cobalt chromium paclitaxel-eluting coronary stent system
for the prevention of restenosis. The two new stents that will be
evaluated in the GENESIS study are the company's Corio(TM)
pimecrolimus-eluting coronary stent system and the SymBio(TM)
pimecrolimus/paclitaxel-eluting coronary stent system. Enrollment
in the clinical trial is anticipated to commence this summer and be
completed in late 2006 or early 2007. "The SymBio stent capitalizes
on the advantages of Conor's reservoir-based stent design to
deliver more than one drug. In addition, the use of bioresorbable
polymers ensures that no permanent polymer residue or drug remains
at the target site, which may confer a long-term advantage with
respect to reduced rates of late stent thrombosis," said Keith D.
Dawkins, M.D., FRCP, FACC, Director of Cardiac Interventions at
Southampton University Hospital, Southampton, United Kingdom, and
one of the principal investigators for the GENESIS study. "I am
privileged to have treated the first patient with the SymBio stent
and to be part of this innovative clinical trial comparing Conor's
two new drug-eluting stents with the company's CoStar stent." "Our
goal is to bring innovative products to patients in the treatment
of coronary artery disease," said Azin Parhizgar, Ph.D., Chief
Operating Officer of Conor. "We are excited to begin a clinical
study that evaluates the anti-inflammatory pimecrolimus and the
anti-proliferative paclitaxel in a single stent with independent
drug release kinetics." The GENESIS trial will be a prospective,
randomized, multi-center, open label, three-arm, non-inferiority
trial designed to enroll up to 375 patients to compare the safety
and efficacy of the Corio and SymBio stents to the CoStar stent in
the treatment of de novo coronary lesions. Patients will be
asymmetrically randomized among the three stents and will undergo
clinical follow-up at 30 days and coronary angiography at six
months, with clinical follow-up at 12 months and annually
thereafter to five years. In addition, a 30-patient subset in each
treatment arm will undergo intravascular ultrasound (IVUS)
evaluation at six months. The primary endpoint for the GENESIS
study will be angiographic in-stent late lumen loss at six-month
follow-up. Other endpoints will 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 study will be conducted at up to 25 centers in
Europe and Israel. In addition to Dr. Dawkins, Stefan Verheye,
M.D., Ph.D. of the Middleheim Hospital, Antwerp, Belgium, is also a
principal investigator for the trial. 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. Paclitaxel is an
anti-proliferative drug initially developed to treat certain types
of cancer. 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. The
CoStar stent is not available for sale in the United States where
it is an investigational device limited by law to investigational
use. 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 and SymBio stents. 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 and SymBio stents,
which are in early stage clinical development, may not demonstrate
safety or efficacy in humans, (b) the risk that the GENESIS trial
may not begin on time, or at all, including as a result of patients
not enrolling in the trial at the rate the company expects, (c) the
risk that the GENESIS 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 or SymBio stents which could
result in termination of the trial, substantial delays or a
redesign of the trial, (d) 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, (e) the risk that issues
in the company's manufacturing processes could delay or impede the
company's clinical development plans, and (f) the risk that
clinical trial sites may decide not to participate or to cease
participation in the GENESIS 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: investor,
Michael Boennighausen, Chief Financial Officer of Conor Medsystems,
Inc., +1-650-614-4100; or Karen L. Bergman of BCC Partners,
+1-650-575-1509, for Conor Medsystems, Inc.; or Nan Foster,
+1-415-307-6955, for Conor Medsystems, Inc. Web site:
http://www.conormed.com/
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