MorphoSys Receives Regulatory Approval to Start Phase 1b/2a Clinical
Trial for MOR103 Program
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Germany's Paul-Ehrlich-Institute Approves Clinical Trial inRheumatoid Arthritis PatientsMorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announcedtoday that it has received clearance from Germany'sPaul-Ehrlich-Institute as well as a positive opinion from the ethicscommittees in Germany to commence a Phase 1b/2a human clinical trialin patients with rheumatoid arthritis (RA) of its lead drug MOR103, afully human monoclonal antibody directed against GranulocyteMacrophage-Colony Stimulating Factor (GM-CSF). In total, therandomized, double-blind, placebo-controlled, dose-escalation trialis expected to enroll 135 patients and will be conducted in multiplecenters in several European countries. Patients with active RAdespite previous therapy with NSAIDs, corticosteroids, DMARDs and/oranti-TNF-alpha will each receive four infusions of either theHuCAL-derived antibody MOR103 or placebo in three ascending dosecohorts. Enrollment is expected to be completed in the first half of2011. The final results of the trial are expected in H1 2012.The primary endpoint of the trial is to determine the safety andtolerability of multiple doses of up to 1.5 mg/kg of MOR103 inpatients with active RA. Secondary outcome measures will evaluatepharmacokinetics, immunogenicity, and the drug's potential to improveclinical signs and symptoms of RA as measured by ACR and EULAR28response criteria and patient reported outcomes."We are pleased to have achieved clearance by the regulatoryauthorities and ethics committees in Germany in such a short timeframe which speaks for the high quality of the application documentsprovided by MorphoSys," commented Dr. Arndt Schottelius, ChiefDevelopment Officer. "We'll continue to work towards finalization ofthe entire approval process in all European countries where we havefiled."About MorphoSys:MorphoSys is an independent biotechnology company that develops novelantibodies for therapeutic, diagnostic and research applications. TheCompany's HuCAL technology is one of the most powerful methodsavailable for generating fully human antibodies. By successfullyapplying this and other proprietary technologies, MorphoSys hasbecome a leader in the field of therapeutic antibodies, one of thefastest-growing drug classes in human health-care. Through itsalliances with some of the world's leading pharmaceutical companies,MorphoSys has created a pipeline of more than 60 drug candidates. TheCompany is expanding its drug pipeline by adding new partneredprograms, and by building a portfolio of fully-owned therapeuticantibodies. For its proprietary portfolio, the Company is focused onthe areas of oncology and inflammation, within which it plans to haveeight active programs by the end of 2009. Its most advanced programis MOR103, a first-in-class, fully human antibody against GM-CSF.MorphoSys expects to commence a Phase Ib/IIa trial of this antibodyin rheumatoid arthritis patients in the second half of 2009. Via itsbusiness unit AbD Serotec, MorphoSys is expanding the reach of itstechnologies in the diagnostics and research markets. MorphoSys isheadquartered in Munich, Germany and listed on the Frankfurt StockExchange under the symbol "MOR". For further information, visithttp://www.morphosys.com/HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay® and RapMAT® areregistered trademarks of MorphoSys AG.This communication contains certain forward-looking statementsconcerning the MorphoSys group of companies. The forward-lookingstatements contained herein represent the judgment of MorphoSys as ofthe date of this release and involve risks and uncertainties. Shouldactual conditions differ from the Company's assumptions, actualresults and actions may differ from those anticipated. MorphoSys doesnot intend to update any of these forward-looking statements as faras the wording of the relevant press release is concerned.For more information, please contact MorphoSys:Dr. Claudia Gutjahr-LöserHead 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.comhttp://hugin.info/130295/R/1353484/327840.pdfhttp://hugin.info/130295/R/1353484/327859.tif --- End of Message ---MorphoSys AGLena-Christ-Str. 48 Martinsried / München GermanyWKN: 663200; ISIN: DE0006632003; Index: CDAX, HDAX, Prime All Share, TECH All Share, TecDAX, MIDCAP;Listed: Prime Standard in Frankfurter Wertpapierbörse, Freiverkehr in Börse Berlin, Freiverkehr in Börse Düsseldorf, Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr in Niedersächsische Börse zu Hannover, Freiverkehr in Bayerische Börse München, Freiverkehr in Börse Stuttgart, Regulierter Markt in Frankfurter Wertpapierbörse;
Datum: 09.11.2009 - 07:30 Uhr
Sprache: Deutsch
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