Medarex, Inc.
(Nasdaq: MEDX) announced that it has initiated the Phase 2 clinical
development program of MDX-1100, a fully human monoclonal antibody that
targets CXCL10 (also known as IP-10), in ulcerative colitis (UC) and
rheumatoid arthritis (RA). MDX-1100 could potentially treat UC and RA by
suppressing the inflammatory process characteristic of these diseases.
"Based on positive safety data in Phase 1 studies, we have initiated
patient enrollment in Phase 2 studies that are designed to establish
proof-of-concept," said Geoffrey M. Nichol, M.B.Ch.B., Senior Vice
President of Product Development at Medarex. "We are optimistic about the
broad potential of MDX-1100 to address a range of inflammatory diseases."
Patients in the Phase 2 randomized, double-blind, placebo-controlled,
multi-center study in UC will be administered MDX-1100 at 10 mg/kg or
placebo every 2 weeks for a total of 4 doses. All patients will have active
UC and will continue standard UC therapy during the trial. The trial is
expected to enroll 106 patients at multiple sites internationally. The
primary endpoint of the study is the response rate at 8 weeks. Clinical
response is based on the Mayo score, a composite endpoint that assesses
stool frequency and the amount of bloody stool per day as recorded in a
patient diary, physician global assessment and the assessment of colon
mucosal inflammation ascertained by endoscopy.
Patients in the Phase 2 randomized, double-blind, placebo-controlled,
multi-center study in RA will be administered MDX-1100 at 10 mg/kg or
placebo every 2 weeks for a total of 6 doses. All patients will have active
RA while on methotrexate. The trial is expected to enroll 70 patients at
multiple sites in Europe. The primary endpoint of the study is the ACR20
response, a composite endpoint that indicates a 20% improvement in RA signs
and symptoms, at 12 weeks.
Medarex also announced that results from the MDX-1100 Phase 1 trials
will be presented at the Digestive Disease Week (DDW) meeting, being held
May 17 - 22, 2008 in San Diego. The following abstracts are expected to be
the subject of presentations at the DDW 2008 conference:
-- "A Double-Blind, Placebo-Controlled, Dose-Escalation, Safety and
Pharmacokinetic Study of MDX-1100, a Fully Human Anti-CXCL10 Monoclonal
Antibody, in Healthy Subjects" (Abstract #T1145) - Poster presentation
on May 20, 2008 from 12:00 to 2:00 PM CDT.
-- "A Phase 1 Open-Label, Single-Dose, Dose-Escalation Study of MDX-1100,
a High-Affinity, Neutralizing, Fully Human IgG1k Anti-CXCL10 (IP10)
Monoclonal Antibody, in Ulcerative Colitis" (Abstract #704) - Oral
presentation on May 20, 2008 from 3:00 to 3:15 PM CDT.
-- "CXCL10 Expression and Biological Activities in Inflammatory Bowel
Disease" (Abstract #W1170) - Poster presentation on May 21, 2008 from
12:00 to 2:00 PM CDT.
These presentations support the development of MDX-1100 for the
treatment of inflammatory diseases such as ulcerative colitis and
rheumatoid arthritis.
About MDX-1100
MDX-1100 is a fully human antibody that targets CXCL10 (also known as
IP-10), a chemokine expressed in association with multiple inflammatory
disease indications such as rheumatoid arthritis, inflammatory bowel
disease and multiple sclerosis.
About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic inflammatory bowel disease of the
colon and is characterized by inflammation and ulceration of the lining of
the colon. Symptoms typically include bloody diarrhea and abdominal pain
and in severe cases may require colectomy. According to the Crohn's &
Colitis Foundation of America, it is estimated that there are up to
approximately 500,000 Americans with ulcerative colitis.
About Rheumatoid Arthritis
According to the American College of Rheumatology, more than two
million Americans suffer from rheumatoid arthritis (RA), a chronic
autoimmune disease that develops when certain cells of the immune system
inappropriately attack healthy joint tissue, thereby causing swelling,
inflammation and damage of joints, as well as systemic inflammation and
damage of other tissues.
About Medarex
Medarex is a biopharmaceutical company focused on the discovery,
development and potential commercialization of fully human antibody-based
therapeutics to treat life-threatening and debilitating diseases, including
cancer, inflammation, autoimmune disorders and infectious diseases. Medarex
applies its UltiMAb(R) technology and product development and clinical
manufacturing experience to generate, support and potentially commercialize
a broad range of fully human antibody product candidates for itself and its
partners. Over forty of these therapeutic product candidates derived from
Medarex technology are in human clinical testing or have had INDs submitted
for such trials, with seven of the most advanced product candidates
currently in Phase 3 clinical trials or the subject of regulatory
applications for marketing authorization. Medarex is committed to building
value by developing a diverse pipeline of antibody products to address the
world's unmet healthcare needs. For more information about Medarex, visit
its website at medarex.
Medarex Statement on Cautionary Factors
Except for the historical information presented herein, matters
discussed herein relating to the development of MDX-1100 constitute
forward-looking statements, as defined by the Private Securities Litigation
Reform Act of 1995, that are subject to certain risks and uncertainties
that could cause actual results to differ materially from any future
results, performance or achievements expressed or implied by such
statements. Statements that are not historical facts, including statements
preceded by, followed by, or that include the words "preliminary";
"potential"; "may"; or similar statements are forward-looking statements.
Medarex disclaims, however, any intent or obligation to update these
forward-looking statements. Risks and uncertainties include risks
associated with the development of MDX-1100, unforeseen safety issues
resulting from the administration of antibody products in humans, as well
as risks detailed from time to time in Medarex's public disclosure filings
with the U.S. Securities and Exchange Commission (SEC), including its
Annual Report on Form 10-K for the fiscal year ended December 31, 2007 and
its quarterly reports on Form 10-Q. There can be no assurance that such
product development efforts will succeed, or whether other developed
products will receive required regulatory clearance or that, even if such
regulatory clearance were received, such products would ultimately achieve
commercial success. Copies of Medarex's public disclosure filings are
available from its investor relations department.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks
of Medarex, Inc. All rights are reserved.
Medarex, Inc.
medarex
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