Data Supportive of Phase 2 Clinical Development Program Currently Underway
PRINCETON, N.J., May 21 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) announced today positive safety data from two Phase 1 trials
that support the Phase 2 clinical development program of MDX-1100, a fully
human monoclonal antibody that targets CXCL10 (also known as IP-10), for
the treatment of inflammatory diseases. MDX-1100 could potentially treat
diseases such as ulcerative colitis (UC) and rheumatoid arthritis (RA) by
suppressing the inflammatory process characteristic of these diseases.
Results from the Phase 1 trials were presented at the Digestive Disease
Week (DDW), being held May 17-22, 2008 in San Diego. (Abstracts #704,
#T1145 and #W1170)
A Phase 1 open-label pilot study was conducted to evaluate the safety
(primary endpoint) and preliminary efficacy of escalating single doses of
MDX-1100 in 11 patients with moderate to severe UC. This study demonstrated
that single doses (ranging from 0.3 to 10.0 mg/kg) of MDX-1100 in patients
with active UC were safe and well-tolerated. Four patients in the study had
protocol-defined clinical responses, determined by the Ulcerative Colitis
Disease Activity Index (UCDAI) which scores the frequency and the amount of
bloody stool per day that is recorded in a patient diary, physician global
assessment and the assessment of colon mucosal inflammation ascertained by
endoscopy. None of the three serious adverse events reported in the study
were considered drug related. (Abstract #704)
A separate Phase 1 double-blind, placebo-controlled study was conducted
to determine safety and pharmacokinetics of escalating single doses
(ranging from 0.01 to 10 mg/kg) of MDX-1100 in 50 healthy volunteers.
MDX-1100 demonstrated dose-proportional pharmacokinetics, and a potential
pharmacodynamic effect that signaled a decrease in the production of CXCL10
was observed at 10 mg/kg. There were no infusion reactions, and the drug
was non-immunogenic. No serious adverse effects were observed in this
study. The most common drug related adverse events were drowsiness, cough
and shortness of breath. (Abstract #T1145)
"The safety and preliminary efficacy data from these Phase 1 studies
provide the foundation for our recently initiated Phase 2 program with MDX-
1100," said Geoffrey M. Nichol, Senior Vice President, Product Development
of Medarex. "We are excited with the Phase 2 program and look forward to
the outcome of the proof-of-concept studies in ulcerative colitis and
rheumatoid arthritis."
Additional studies presented at DDW demonstrated that CXCL10 induced
expression of several pro-inflammatory molecules and that these CXCL10
inducible genes were upregulated in patients with ulcerative colitis.
(Abstract #W1170)
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. Published data suggests that CXCL10 plays
key roles in murine models of inflammatory bowel disease (IBD) and RA.
Moreover, CXCL10 levels are increased in patients with these diseases.
Phase 2 proof-of-concept clinical trials of MDX-1100 in ulcerative colitis
and rheumatoid arthritis have been initiated.
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 http://www.medarex.com.
Medarex Statement on Cautionary Factors
Except for the historical information presented herein, matters
discussed herein relating to the development of MDX-1100 may 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.
SOURCE Medarex, Inc.
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CONTACT:
Laura S. Choi, Investor Relations,
+1-609-430-2880, ext. 2216, or Nichol Harber, Corporate
Communications (media), +1-609-430-2880, ext. 2214, both of
Medarex, Inc.
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