10-11-2009: MorphoSys AG announced 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.
MorphoSys AG announced that the Company will nominate Ms. Karin Eastham and Dr. Marc Cluzel as new members of the Supervisory Board at the Company's Annual Shareholder Meeting on Thursday, May 31, 2012. Ms. Eastham and Dr. Cluzel will replace Prof. Dr. Jürgen Drews and Dr. Metin Colpan. Pro ... more
MorphoSys AG announced that the US Patent and Trademark Office (USPTO) has granted a patent covering the Company's cancer compound MOR202. The new patent (US 8,088,896) covers MorphoSys's HuCAL antibody against CD38 as well as pharmaceutical compositions comprising the same, and has a sched ... more
MorphoSys AG announced that a phase 1b clinical trial evaluating MOR103, a human monoclonal antibody to GM-CSF (granulocyte macrophage-colony stimulating factor), in patients with multiple sclerosis (MS) is now open for enrollment, thereby adding a second indication to the development progr ... more
As one of the leading public biotech companies in Europe, we are committed to developing the medicines of the future. Building on our portfolio of innovative antibody technologies, we are actively pursuing new therapeutic approaches in close collaboration with the world‘s foremost pharmaceu ... more
MorphoSys AG, located in Martinsried/Munich, is one of the worlds leading biotechnology companies focusing on fully human antibodies. With its unique technologies, MorphoSys is developing the next generation of therapeutic antibodies which can be used not only for research and diagnostics b ... more
MorphoSys AG announced 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 m ... more
Vakzine Projekt Management GmbH (VPM) and the European Malaria Vaccine Initiative (EMVI) are cooperating in compiling and submitting the Phase I clinical trial application of malaria vaccine GMZ2 to the Paul-Ehrlich-Institute and to the Ethics Committee Tübingen, Germany. In addition, VPM s ... more
GPC Biotech AG announced that it had received clearance from the Paul-Ehrlich-Institut (PEI) to initiate human clinical testing in Germany with the 1D09C3 anticancer monoclonal antibody. The PEI is the German national agency responsible for regulating biological and blood products.
The stu ... more