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MorphoSys Announces Completion of First Dosing in Phase 1 Trial for
MOR103 Program |
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MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today
announced the completion of a first dosing regimen in a phase 1
clinical study on healthy volunteers of the HuCAL-derived antibody
MOR103 with no adverse events reported. Six healthy volunteers in the
first dosing group have been enrolled and received MOR103 injections,
while three volunteers received placebo. The safety review of the
medical data from the lowest dosing group yielded a determination
that it was safe to proceed with the second dosing group. The
randomized, double-blind, placebo-controlled, single-ascending dose
trial will be conducted in approx. 50 healthy volunteers and is being
conducted in a Clinical Pharmacology Unit (CPU) in Utrecht, the
Netherlands. The trial is scheduled to be finalized in 2008 and final
reporting is expected in Q1 2009.
The Company's lead development program, MOR103, is a fully human
HuCAL antibody directed against GM-CSF (granulocyte macrophage-colony
stimulating factor), being developed in the area of inflammatory
diseases, such as rheumatoid arthritis, where current treatment
options are inadequate. Due to its diverse functions in the immune
system, GM-CSF can be considered a target for a broad spectrum of
anti-inflammatory therapies. MorphoSys had submitted the clinical
trial application in December 2007 and received the approval by the
Dutch authorities six weeks later. The study will evaluate the safety
and tolerability as well as pharmacokinetics of escalating doses of
MOR103.
"We are very pleased to see our first proprietary drug candidate
progress according to plan," commented Dr. Marlies Sproll, Chief
Scientific Officer of MorphoSys AG. "Antibodies that neutralize
GM-CSF could represent a new generation of medicines that reduce
inflammation with greater beneficial effects."
For further information please contact: Dr. Claudia Gutjahr-Löser,
Head of Corporate Communications & Investor Relations, Tel: +49 (0)
89 / 899 27-122, gutjahr-loeser@morphosys.com or Mario Brkulj,
Manager Corporate Communications & Investor Relations, Tel: +49 (0)
89 / 899 27-454, brkulj@morphosys.com
About MorphoSys:
MorphoSys is a publicly traded biotechnology company focused on the
generation of fully human antibodies as a means to discover and
develop innovative antibody-based drugs against life-threatening
diseases. MorphoSys's goal is to establish HuCAL as the technology of
choice for antibody generation in research, diagnostics and
therapeutic applications. The Company currently has therapeutic and
research alliances with the majority of the world largest
pharmaceutical companies including Boehringer Ingelheim,
Centocor/Johnson & Johnson, Novartis, Pfizer and Roche. Within these
partnerships, more than 50 therapeutic antibody programs are ongoing
in which MorphoSys participates through exclusive license and
milestones payments as well as royalties on any end products.
Additionally, MorphoSys is active in the antibody research market
through its AbD Serotec business unit. The business unit has
operations in Germany (Munich), the U.S. (Raleigh, NC) and U.K.
(Oxford). For further information please visit
http://www.morphosys.com/
About MOR103 to treat RA:
Rheumatoid arthritis (RA) is traditionally considered a chronic,
inflammatory autoimmune disorder that causes the immune system to
attack the joints and affects in particular a membrane, called
synovium, which lines each movable joint. It is a disabling and
painful inflammatory condition, which can lead to substantial loss of
mobility due to pain and joint destruction. As a systemic disease, RA
often affects extra-articular tissues throughout the body including
the skin, blood vessels, heart, lungs, and muscles. The disease
affects approximately 4-6 million people worldwide. In patients
suffering from RA, white blood cells move from the bloodstream into
the synovium. Here, these blood cells appear to play an important
role in causing the synovial membrane to become inflamed. The
HuCAL-based antibody MOR103 targets GM-CSF as a means to treat
inflammatory diseases such as psoriasis, multiple sclerosis (MS),
chronic obstructive pulmonary disease (COPD), asthma, and especially
RA. The granulocyte macrophage colony-stimulating factor (GM-CSF)
stimulates stem cells to produce granulocytes and macrophages, and
subsequently activates these differentiated immune cells. GM-CSF is
part of the natural immune and inflammatory cascade but has also been
identified as an inflammatory mediator in autoimmune disorders like
RA leading to an increased production of pro-inflammatory cytokines,
chemokines and proteases and thereby ultimately to articular
destruction. By neutralizing GM-CSF the HuCAL-based antibody MOR103
reduces undesired proliferation and activation of inflammatory
granulocytes and macrophages and intervenes in several
pathophysiological pathways. More information and picture material is
available at: http://www.morphosys.com/en/mor103
HuCAL® and HuCAL GOLD® are registered trademarks of MorphoSys AG
This communication contains certain forward-looking statements
concerning the MorphoSys group of companies. The forward-looking
statements contained herein represent the judgment of MorphoSys as of
the date of this release and involve risks and uncertainties. Should
actual conditions differ from the Company's assumptions, actual
results and actions may differ from those anticipated. MorphoSys does
not intend to update any of these forward-looking statements as far
as the wording of the relevant press release is concerned.
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