MorphoSys Announces Completion of First Dosing in Phase 1 Trial for MOR103 Program
News Apr 28, 2008
MorphoSys AG has announced the completion of a first dosing regimen in a phase 1 clinical study on healthy volunteers of the HuCAL-derived antibody MOR103 with no adverse events reported. Six healthy volunteers in the first dosing group have been enrolled and received MOR103 injections, while three volunteers received placebo.
The safety review of the medical data from the lowest dosing group yielded a determination that it was safe to proceed with the second dosing group. The randomized, double-blind, placebo-controlled, single-ascending dose trial will be conducted in approx. 50 healthy volunteers and is being conducted in a Clinical Pharmacology Unit (CPU) in Utrecht, the Netherlands. The trial is scheduled to be finalized in 2008 and final reporting is expected in Q1 2009.
The Company's lead development program, MOR103, is a fully human HuCAL antibody directed against GM-CSF (granulocyte macrophage-colony stimulating factor), being developed in the area of inflammatory diseases, such as rheumatoid arthritis, where current treatment options are inadequate. Due to its diverse functions in the immune system, GM-CSF can be considered a target for a broad spectrum of anti-inflammatory therapies. MorphoSys had submitted the clinical trial application in December 2007 and received the approval by the Dutch authorities six weeks later. The study will evaluate the safety and tolerability as well as pharmacokinetics of escalating doses of MOR103.
"We are very pleased to see our first proprietary drug candidate progress according to plan," commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. "Antibodies that neutralize GM-CSF could represent a new generation of medicines that reduce inflammation with greater beneficial effects."
PhoreMost and o2h Discovery Collaborate to Progress First-in-Class Drug Discovery ProgramsNews
PhoreMost, the UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets, announced it has entered into a collaboration with o2h discovery (o2h), an Anglo-Indian medicinal chemistry company that has in-house capability to take drug discovery programmes to the IND filing stage.READ MORE
New Speakers from Roche and Imperial College London Announced for SMi’s ADMET EventNews
SMi Group Reports: With less than 4 weeks left until the 13th annual ADMET Conference commences in London, SMi announces two new speakers joining the event.READ MORE
Compound as Effective as FDA-Approved Drugs Against Life-Threatening InfectionsNews
Purdue University researchers have identified a new compound that in preliminary testing has shown itself to be as effective as antibiotics approved by the Food and Drug Administration to treat life-threatening infections while also appearing to be less susceptible to bacterial resistance.READ MORE