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MorphoSys AG (MUC:MOR) Antibody Shows Ability to Inhibit Disease in an Established RA Model
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today the publication of preclinical data from its most advanced proprietary drug development program MOR103, a fully human HuCAL antibody directed against GM-CSF. The preclinical data, which will be presented today at the Human Antibodies and Hybridomas (HAH) Conference in New York, USA, provides strong supporting evidence for MOR103 as a treatment for rheumatoid arthritis (RA), and forms the basis for the Phase 1 clinical trial currently ongoing.
"The results published today augment the growing data package we have around our lead proprietary program MOR103 and add further value to the program," commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys. "These findings support our understanding of the target biology of GM-CSF. Specifically we believe that GM-CSF is a key mediator in the inflammatory cascade, leading to increased production of other pro-inflammatory cytokines, chemokines and proteases and thereby ultimately to articular destruction in RA."
The data released today show that MOR103 inhibits the signs and symptoms of RA in vivo, in a dose-dependent manner. The study used the established streptococcal cell wall-induced arthritis model in rats. The antibody was administered in a range of concentrations, and brought about significant reduction of knee joint swelling and improvement in joint histopathology in a dose-dependent manner. In addition, significantly reduced cytokine levels and white blood cell influx were observed in the synovium surrounding the joints. No relevant toxicity effects were observed in a standard repeat dose rhesus monkey study.
In vitro, MOR103 showed very strong binding to human GM-CSF, blocking binding to the GM-CSF receptor and effectively inhibiting inflammatory disease-related physiology such as cell proliferation, cell migration and activation. Additionally, the antibody exhibited very high target specificity, with no cross-reactivity to other pro-inflammatory cytokines such as IL-3, IL-4, IL-5 or M-CSF nor any non-specific binding to a panel of human tissues. MOR103 also recognizes rat and rhesus GM-CSF, both helpful criteria with regard to the development process.
MOR103 is currently being tested in a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of this fully human HuCAL antibody. The Phase 1 trial is a randomized, double-blind, placebo-controlled, single-ascending dose study and is being conducted in seven groups with nine healthy volunteers in each cohort. The dosing of all volunteers has been completed and follow-up analysis is ongoing. Final data are expected in Q2 2009.
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 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 hematopoietic precursor 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
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's 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/
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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