Researchers to Report on the Investigational Use of Alexion's Soliris® (Eculizumab) to Prevent Antibody-Mediated Rejection in High-Risk Kidney Transplant Patients
Abstracts Of Presentations at the American Transplant Congress
Available Online
CHESHIRE, Conn., May 28, 2009 (BUSINESS WIRE) -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that
researchers are scheduled to present early clinical and laboratory data
on the potential role of terminal complement inhibition with Soliris(R)
(eculizumab) for the treatment of a subset of kidney transplant patients
who are at high risk for antibody-mediated rejection (AMR) of their
grafts. These data will be included in three oral sessions and one
poster presentation at the American Transplant Congress being held May
30 to June 2, 2009 at the Hynes Convention Center in Boston. This
research includes interim results from an investigator-initiated study
of Soliris(R) for the prevention of AMR in this sub-population
of kidney transplant patients.
Abstracts listed below can be accessed at: http://www.abstracts2view.com/atc/sessionindex.php.
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Abstract #178 will be presented during an oral session (Concurrent
Session 25) on Sun., May 31 at 4:48 p.m.:
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- "Prevention of Acute Humoral Rejection with C5 Inhibition," Dr.
Mark D. Stegall, et al.
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Abstract #393 will be presented during a plenary session (Plenary
Session III) on Tues., June 2 at 9:45 a.m.:
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- "Prevention of Endothelial Activation with C5 Inhibition in
Positive-Crossmatch Kidney Transplants (+XMKTx)," Dr. Lynn D.
Cornell, et al.
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Abstract #62 will be presented during an oral session (Concurrent
Session 9) on Sun., May 31 at 2:15 p.m.:
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- "Anti-C5 mAb Plus Low Dose CTLA4 Ig Inhibit Alloreactive T Cells
and Prolong Heart Graft Survival in Mice," Dr. Staci A. Leisman,
et al.
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Abstract #755 will be presented during a poster session (Kidney
Immunosupression: Novel Agents) on Sat., May 30 from 5:30 - 7:00
p.m.:
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- "Complement C5 Inhibitor - Is It Useful in Antibody-Mediated
Rejection?" Rizwan Hamer, et al.
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About Soliris
Soliris has been approved by the U.S. Food and Drug Administration
(March 2007), the European Commission (June 2007), Health Canada
(January 2009) and Australia's Therapeutic Goods Administration
(February 2009) as the first treatment for all patients with paroxysmal
nocturnal hemoglobinuria (PNH), a rare, debilitating and
life-threatening blood disorder defined by hemolysis, or the destruction
of red blood cells. All four jurisdictions reviewed and approved their
respective marketing applications for Soliris under their priority
review or accelerated assessment procedures, and all four have
designated Soliris as an orphan drug. Soliris is not approved for the
treatment of transplant rejection. More information on Soliris is
available at www.soliris.net.
Important Safety Information
Soliris is generally well tolerated. The most frequent adverse events
observed in clinical studies were headache, nasopharyngitis (a runny
nose), back pain and nausea. Treatment with Soliris should not alter
anticoagulant management because the effect of withdrawal of
anticoagulant therapy during Soliris treatment has not been established.
The U.S. product label for Soliris also includes a boxed warning:
"Soliris increases the risk of meningococcal infections. Vaccinate
patients with a meningococcal vaccine at least two weeks prior to
receiving the first dose of Soliris; revaccinate according to current
medical guidelines for vaccine use. Monitor patients for early signs of
meningococcal infections, evaluate immediately if infection is
suspected, and treat with antibiotics if necessary." During clinical
studies, two out of 196 vaccinated PNH patients treated with Soliris
experienced a serious meningococcal infection. Prior to beginning
Soliris therapy, all patients and their prescribing physicians are
encouraged to enroll in the PNH Registry, which is part of a special
risk-management program that involves initial and continuing education
and long-term monitoring for detection of new safety findings.
About Alexion
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to
develop and deliver life-changing drug therapies for patients with
serious and life-threatening medical conditions. Alexion is engaged in
the discovery, development and commercialization of therapeutic products
aimed at treating patients with a wide array of severe disease states,
including hematologic and kidney diseases, transplant, cancer, and
autoimmune disorders. Soliris is Alexion's first marketed product,
approved in the U.S. and Europe in 2007, and Canada and Australia in
2009. Alexion is evaluating other potential indications for Soliris as
well as other formulations of eculizumab for additional clinical
indications, and is pursuing development of other antibody product
candidates in early stages of development. This press release and
further information about Alexion Pharmaceuticals, Inc. can be found at www.alexionpharma.com.
[ALXN-G]
SOURCE: Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Irving Adler, 203-271-8210
Sr. Director, Corporate Communications
or
Media:
Makovsky & Company
Kristie Kuhl, 212-508-9642
or
Investors
Rx Communications
Rhonda Chiger, 917-322-2569
Copyright Business Wire 2009