Free Submission Public Relations & NewsPR-inside.com
 
DeutschEnglish

Get the latest news
with our RSS feed
rss feed
Add to My Yahoo!
More information
Business

MorphoSys Receives Regulatory Approval to Start Phase 1b/2a Clinical Trial for MOR103 Program


Print article Print article
Refer this article Refer to a friend
Copyright © Hugin AS 2009. All rights reserved.
2009-11-09 07:32:01 -


London, November , 09, 2009
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 in
Rheumatoid Arthritis Patients

MorphoSys AG  (FSE: MOR;  Prime Standard  Segment, TecDAX)  announced
today   that    it   has    received   clearance    from    Germany's
Paul-Ehrlich-Institute as well as a positive opinion from the  ethics
committees in Germany to commence a Phase 1b/2a human clinical  trial
in patients with rheumatoid arthritis (RA) of its lead drug MOR103, a
fully  human   monoclonal  antibody   directed  against   Granulocyte
Macrophage-Colony  Stimulating   Factor  (GM-CSF).   In  total,   the
randomized, double-blind,  placebo-controlled, dose-escalation  trial
is expected to enroll 135 patients and will be conducted in  multiple
centers in  several  European  countries.  Patients  with  active  RA
despite previous therapy with NSAIDs, corticosteroids, DMARDs  and/or
anti-TNF-alpha  will  each  receive  four  infusions  of  either  the
HuCAL-derived antibody  MOR103 or  placebo  in three  ascending  dose
cohorts. Enrollment is expected to be completed in the first half  of
2011. The final results of the trial are expected in H1 2012.

The primary endpoint  of the  trial is  to determine  the safety  and
tolerability of  multiple doses  of  up to  1.5  mg/kg of  MOR103  in
patients with  active RA.  Secondary outcome  measures will  evaluate
pharmacokinetics, immunogenicity, and the drug's potential to improve
clinical signs and  symptoms of  RA as  measured by  ACR and  EULAR28
response criteria and patient reported outcomes.

"We  are  pleased  to  have  achieved  clearance  by  the  regulatory
authorities and ethics  committees in  Germany in such  a short  time
frame which speaks for the high quality of the application  documents
provided  by  MorphoSys,"  commented  Dr.  Arndt  Schottelius,  Chief
Development Officer.  "We'll continue to work towards finalization of
the entire approval process in  all European countries where we  have
filed."


About MorphoSys:
MorphoSys is an independent biotechnology company that develops novel
antibodies for therapeutic, diagnostic and research applications. The
Company's HuCAL  technology  is  one of  the  most  powerful  methods
available for  generating  fully human  antibodies.  By  successfully
applying this  and  other  proprietary  technologies,  MorphoSys  has
become a leader in  the field of therapeutic  antibodies, 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 is  expanding  its  drug pipeline  by  adding  new  partnered
programs, and  by building  a  portfolio of  fully-owned  therapeutic
antibodies. For its proprietary portfolio, the Company is focused  on
the areas of oncology and inflammation, within which it plans to have
eight active programs by the end  of 2009. Its most advanced  program
is MOR103,  a first-in-class,  fully human  antibody against  GM-CSF.
MorphoSys expects to commence a  Phase Ib/IIa trial of this  antibody
in rheumatoid arthritis patients in the second half of 2009. Via  its
business unit AbD Serotec,  MorphoSys is expanding  the reach of  its
technologies in the  diagnostics and research  markets. MorphoSys  is
headquartered in Munich,  Germany and listed  on the Frankfurt  Stock
Exchange under  the symbol  "MOR". For  further information,  visit
www.morphosys.com/


HuCAL®, HuCAL  GOLD®, HuCAL  PLATINUM®, CysDisplay®  and RapMAT®  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.


For more information, please contact MorphoSys:
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-122

Mario Brkulj
Senior Manager Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-454

Jessica Kulpi
Specialist Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-332

investors@morphosys.com

hugin.info/130295/R/1353484/327840.pdf

hugin.info/130295/R/1353484/327859.tif


 
--- End of Message ---

MorphoSys AG
Lena-Christ-Str. 48 Martinsried / München Germany

WKN: 
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;


Disclaimer: © 2009 Hugin. The press releases or report contained herein is protected by copyright and other applicable laws, treaties and conventions. Information contained in the releases is furnished by Hugin's, who warrant that they are solely responsible for the content, accuracy and originality of the information contained therein. All reproduction, other than for an individual user's personal reference, is prohibited without prior written permission.
Terms & Conditions | Privacy | About us | Contact PR-inside.com