MorphoSys Enrolls First Patient in Phase 1b/2a Clinical Trial for MOR103 Program in Rheumatoid Arthr
(Thomson Reuters ONE) - MorphoSys AG / MorphoSys Enrolls First Patient in Phase 1b/2a Clinical Trial for MOR103 Program in Rheumatoid Arthritis processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement. Company Provides Guidance on R&D Investment in 2010MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that ithas enrolled the first patient in its Phase 1b/2a clinical trial of its leaddrug MOR103. The Company's lead development program, MOR103, is a fully humanHuCAL antibody directed against GM-CSF (granulocyte macrophage-colonystimulating factor), being developed in the area of inflammatory diseases, suchas rheumatoid arthritis (RA), where current treatment options are inadequate."We are very pleased that our Phase 1b/2a study in patients with rheumatoidarthritis has now started according to plan," commented Dr. Arndt Schottelius,Chief Development Officer. "This is an important step for MorphoSys, since wewill test an antibody from our growing proprietary pipeline for the first timein patients. We have thus made significant progress in bringing a potentialfuture drug with a promising new mechanism of action closer to patients. Thepast year saw a major expansion of MorphoSys's development team andcapabilities. Today's news also demonstrates that we have made major progress inbuilding an excellent development organization capable of producing andadvancing valuable drug candidates."In total, the randomized, double-blind, placebo-controlled, dose-escalationtrial is expected to enroll 135 patients and will be conducted in multiplecenters in several European countries. Patients with active RA despite previoustherapy with NSAIDs, corticosteroids, DMARDs and/or anti-TNF-alpha therapieswill each receive four infusions of either the HuCAL-derived antibody MOR103 orplacebo in three ascending dose cohorts. Enrollment is expected to be completedin the first half of 2011 with the final results expected in H1 2012.The primary endpoint of the trial is to determine the safety and tolerability ofmultiple doses of up to 1.5 mg/kg of MOR103 in patients with active RA.Secondary outcome measures will evaluate pharmacokinetics, immunogenicity, andthe drug's potential to improve clinical signs and symptoms of RA as measured byreduction of synovitis and bone edema as well as by ACR/ EULAR28 responsecriteria and patient reported outcomes.Proprietary R&D Investment 2010The phase 1b/2a trial for MOR103 is expected to constitute a significant shareof MorphoSys's anticipated proprietary R&D investment in 2010 of EUR 26 millionto EUR 29 million. In addition to conducting the phase 1b/2a trial in RA andpreparing for phase 2 testing of MOR103 in a second indication, MorphoSys willfurther accelerate and expand its proprietary development activities during thenext 12 months. The Company plans to add up to four new proprietary programsincluding both fully owned and co-development opportunities. MorphoSys todayreconfirmed its commitment to remaining profitable and expects the solidbusiness performance and top-line growth of previous years to continue through2010. More specific financial guidance for 2010 will be given at the Company'sfull year 2009 results presentation on February 25th, 2010.About MorphoSys:MorphoSys is an independent biotechnology company that develops novel antibodiesfor therapeutic, diagnostic and research applications. The Company's HuCALtechnology is one of the most powerful methods available for generating fullyhuman antibodies. By successfully applying this and other proprietarytechnologies, MorphoSys has become a leader in the field of therapeuticantibodies, one of the fastest-growing drug classes in human health-care.Through its alliances with some of the world's leading pharmaceutical companies,MorphoSys has created a pipeline of more than 60 drug candidates. The Company isexpanding its drug pipeline by adding new partnered programs, and by building aportfolio of fully-owned therapeutic antibodies. For its proprietary portfolio,the Company is focused on the areas of oncology and inflammation. Its mostadvanced program MOR103, a first-in-class, fully human antibody against GM-CSF,is currently tested in a Phase Ib/IIa trial in rheumatoid arthritis patients.Via its business unit AbD Serotec, MorphoSys is expanding the reach of itstechnologies in the diagnostics and research markets. MorphoSys is headquarteredin Munich, Germany and listed on the Frankfurt Stock Exchange under the symbol"MOR". For further information, visithttp://www.morphosys.com/About MOR103 to treat RA:Rheumatoid arthritis (RA) is traditionally considered a chronic, inflammatoryautoimmune disorder that causes the immune system to attack the joints andaffects in particular a membrane, called synovium, which lines each movablejoint. It is a disabling and painful inflammatory condition, which can lead tosubstantial loss of mobility due to pain and joint destruction. As a systemicdisease, RA often affects extra-articular tissues throughout the body includingthe skin, blood vessels, heart, lungs, and muscles. The disease affectsapproximately 4-6 million people worldwide. In patients suffering from RA, whiteblood cells move from the bloodstream into the synovium. Here, these blood cellsappear to play an important role in causing the synovial membrane to becomeinflamed. The HuCAL-based antibody MOR103 targets GM-CSF thereby having thepotential 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 stemcells to produce granulocytes and macrophages and subsequently activates thesedifferentiated immune cells. GM-CSF is part of the natural immune andinflammatory cascade but has also been identified as an inflammatory mediator inautoimmune disorders like RA leading to an increased production ofpro-inflammatory cytokines, chemokines and proteases and thereby ultimately toarticular destruction. By neutralizing GM-CSF the HuCAL-based antibody MOR103reduced in pre-clinical models undesired proliferation and activation ofinflammatory granulocytes and macrophages and intervenes in severalpathophysiological pathways. More information and picture material is availableat: http://www.morphosys.com/en/mor103HuCAL(®), HuCAL GOLD(®), HuCAL PLATINUM(®), CysDisplay(® )and RapMAT(®) areregistered trademarks of MorphoSys AG.This communication contains certain forward-looking statements concerning theMorphoSys group of companies. The forward-looking statements contained hereinrepresent the judgment of MorphoSys as of the date of this release and involverisks and uncertainties. Should actual conditions differ from the Company'sassumptions, actual results and actions may differ from those anticipated.MorphoSys does not intend to update any of these forward-looking statements asfar as the wording of the relevant press release is concerned.For more information, please contact MorphoSys:Dr. Claudia Gutjahr-L?Head of Corporate Communications & IRTel: +49 (0) 89 / 899 27-122Mario BrkuljSenior Manager Corporate Communications & IRTel: +49 (0) 89 / 899 27-454Jessica KulpiSpecialist Corporate Communications & IRTel: +49 (0) 89 / 899 27-332investors(at)morphosys.com
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Datum: 19.01.2010 - 01:00 Uhr
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