Medarex, Inc.
(Nasdaq: MEDX) announced the allowance of two separate
investigational new drug applications (IND) filed with the U.S. Food & Drug
Administration (FDA) for MDX-1342, one for the treatment of chronic
lymphocytic leukemia (CLL) and the other for rheumatoid arthritis. MDX-1342
is a fully human antibody that targets CD19, a molecule specifically
expressed on normal B-cells and malignant B-cells in diseases such as CLL,
acute lymphoblastic leukemia, follicular non-Hodgkins lymphoma, diffuse
large B-cell lymphoma and mantle cell lymphoma.
The IND for the treatment of CLL is for an open-label, multi-dose,
dose-escalation Phase I clinical trial for cancer that is expected to
enroll up to 52 patients with relapsed or refractory CLL. This trial is
designed to establish and evaluate the safety, tolerability and maximum
tolerated dose, as well as preliminary pharmacodynamics and efficacy of
MDX-1342.
The IND for the treatment of rheumatoid arthritis is for a randomized,
single-dose, dose-escalation, placebo-controlled Phase I clinical trial
that is expected to enroll up to 90 patients with rheumatoid arthritis.
This trial is designed to evaluate the safety and tolerability profile of
MDX-1342 and to determine the dose range for B-cell depletion.
"We are pleased with the advancement of a new product candidate from
Medarex's proprietary pipeline into clinical trials," said Howard H. Pien,
President and CEO of Medarex. "We look forward to the continued development
of MDX-1342, which could provide new treatment options for a number of
serious conditions."
About CD19 and MDX-1342
CD19 is a B-cell specific membrane protein that is broadly expressed
during B-cell development, from the pro-B-cell to the early plasma cell
stage.
Clinical studies have demonstrated that depleting monoclonal antibodies
directed against CD20, another B-cell specific membrane protein that has a
more restricted expression pattern than CD19 during B-cell development, are
effective in treating rheumatoid arthritis and various B-cell malignancies,
and show promise in treating other inflammatory diseases such as systemic
lupus erythematosis and multiple sclerosis.
MDX-1342 is a fully human antibody that binds selectively to CD19
expressed on B-cells (without targeting stem cells or fully differentiated
plasma cells, which lack CD19 expression) and induces the depletion and
elimination of CD19-positive B-cells.
About Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia (CLL) is a cancer that affects B-cell
lymphocytes, an important component of the immune system that helps the
body fight infection or cancer. The American Cancer Society estimates that
in 2007, approximately 15,340 new cases of chronic lymphocytic leukemia
will occur in the United States, and approximately 4,500 people will die of
the disease in 2007.
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. More than 30 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 III clinical trials. 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.
Statement on Cautionary Factors
Except for the historical information presented herein, matters
discussed herein may constitute forward-looking statements 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 "expect"; "potential"; "could"; "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 product discovery and
development, uncertainties related to the outcome of clinical trials,
slower than expected rates of patient recruitment, unforeseen safety issues
resulting from the administration of MDX-1342 in patients, uncertainties
related to product manufacturing 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, 2006 and its quarterly reports on Form 10-Q.
There can be no assurance that such development efforts will succeed or
that 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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