�Medarex, Inc.
(Nasdaq: MEDX) announced that its collaborator MedImmune, Inc. has
initiated a Phase 2A multi-dose clinical test of MEDI-545 for the
potential handling of systemic lupus erythematosus (SLE or lupus).
MEDI-545 is a fully human antibody generated by Medarex's UltiMAb Human
Antibody Development System(R). Under the footing of the agreement, Medarex
will welcome a milestone payment of an undisclosed amount.
The Phase 2A clinical visitation is intentional to appraise the guard and
tolerability of multiple subcutaneous loony toons schedules of MEDI-545 or placebo
in adult patients with control to austere active lupus. The study will also
assess the effects of MEDI-545 on disease activity in lupus patients. This
randomized, double blind, placebo-controlled run is expected to enrol 80
patients and testament be conducted at 20 sites in the United States.
MedImmune is as well conducting a Phase 1 clinical trial for MEDI-545 in
idiopathic inflammatory myositis, an immunologic disease that involves
chronic muscle fervour, pain and weakness.
"Data from an earlier reported placebo-controlled Phase 1 study
suggested curative activity with single doses in patients with lupus and
demonstrated an acceptable safety profile," said Geoffrey M. Nichol,
M.B.Ch.B., Senior Vice President of Product Development at Medarex. "We are
selfsame excited about the office of the interferon alpha inflammatory tract
and front forward to exploring its potential in treating patients with lupus
and other autoimmune diseases."
About MEDI-545
MEDI-545 (previously known as MDX-1103) is a fully human monoclonal
antibody targeting interferon-alpha. Published data indicate that levels of
interferon-alpha ar elevated in many patients with active SLE and other
autoimmune disorders, and may be associated with disease activity.
Preclinical information from creature models suggest that MEDI-545 may suppress the
abnormal immune activity associated with lupus by binding to multiple
interferon-alpha subtypes seen in the serum of lupus patients.
In November 2004, MedImmune entered into a collaborationism with Medarex
to focal point on two specific antibodies, one of which was MDX-1103 (now known
as MEDI-545). Under the footing of the agreement, MedImmune is responsible
for all ongoing clinical development activities. Prior to the root of
polar studies, Medarex may elect to co-develop the products in refund for
the opportunity to co-promote and to welcome a portion of the commercial
winnings in the United States. In all other cases, Medarex will be entitled
to have milestone payments and royalties.
About Lupus
Approximately 350,000 individuals in the United States are affected
with lupus, a chronic rabble-rousing disease that causes the body to attack
its own tissues and organs, including the skin, joints, blood and kidneys.
Treatments for lupus include anti-inflammatory drug drugs, antimalarials,
corticosteroids and drugs approved for other purposes, such as
immunosuppressive drug agents minded to cancer patients undergoing chemotherapy
or medicines developed to regale arthritis patients. Lupus occurs about 10
times more frequently in adult females than grownup males, and is two to
iII times more common among African Americans, Hispanics, Asians and
Native Americans.
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
malignant neoplastic disease, inflammation, autoimmune disorders and infectious diseases. Medarex
applies its UltiMAb(R) technology and product evolution and clinical
manufacturing go through to sire, support and potentially commercialise
a broad range of fully human antibody product candidates for itself and its
partners. More than 40 of these therapeutic product candidates derived from
Medarex applied science are in human clinical testing or have had INDs submitted
for such trials, with seven of the almost advanced mathematical product candidates
currently in Phase 3 clinical trials or the subject of regulative
applications for marketing sanction. Medarex is committed to building
value by development a various 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.
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