December 21, 2011 / 7:30 am, CET
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today 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 program. A phase 1b/2a trial in patients with active rheumatoid arthritis is ongoing and is on track to report data by mid of 2012. Additionally, a phase 1 pharmacokinetic (PK) study in healthy volunteers to evaluate a subcutaneous formulation of MOR103 will commence shortly.
"Our proprietary portfolio has made significant progress this year," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "These two new studies further increase the value of our lead proprietary drug MOR103. GM-CSF is strongly implicated in the pathogenesis of inflammatory diseases, including rheumatoid arthritis and multiple sclerosis. Recent in vivo data generated in animal models for MS demonstrate that inhibition of GM-CSF improves disease scores, which further substantiates the decision to choose MS as the second indication for MOR103. My team and I are thus very excited that the phase 1b study in multiple sclerosis has been initiated."
The phase 1b dose-escalation study in multiple sclerosis will determine the safety of three doses of MOR103. In total, 30 patients will be enrolled in the study which is planned to be conducted at sites in Germany, the UK and Poland. Data for this trial is expected to be available in 2013.
The PK study will evaluate the pharmacokinetics, bioavailability, safety and tolerability of subcutaneously administered MOR103 in 32 healthy volunteers. Subcutaneous injection represents a more convenient way of administration for patients and the data will help guide dosing regimens for future clinical trials for MOR103. Enrollment for this trial is expected to be completed in 2012.
MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare. The company's AbD Serotec unit uses HuCAL and other antibody technologies to generate superior monoclonal antibodies for research and diagnostic applications.
Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 70 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT® and arYla® are registered trademarks of MorphoSys. Ylanthia® and 100 billion high potentialsTM are 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.
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