Nov. 9, 2009 (Hugin AS) --
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.
