MedImmune Initiates First Clinical Trial of Monoclonal Antibody Targeting GM-CSFR in Patients with Rheumatoid...( GAITHERSBURG Md. Nov. 26 /- MedIm...),Health

GAITHERSBURG, Md., Nov. 26 /PRNewswire/ -- MedImmune, Inc. today announced that dosing of patients has begun in the first Phase 1 clinical trial of CAM- 3001, a fully human monoclonal antibody (MAb) targeting the alpha subunit of the granulocyte-macrophage colony stimulating factor receptor (GM-CSFR). The study is designed to evaluate the safety and tolerability of single doses of CAM-3001 in patients with rheumatoid arthritis (RA), and represents the first clinical trial in which a MAb targeting GM-CSFR is being investigated in this population. MedImmune currently holds exclusive, worldwide rights to develop and market CAM-3001 under an agreement with CSL Limited.

"Commencing this trial demonstrates that researchers at MedImmune are at the forefront of innovation using monoclonal antibodies and evaluating their potential to serve as new treatment options for patients with chronic, debilitating inflammatory diseases, including rheumatoid arthritis," said Ian Anderson, Ph.D., vice president of research -- respiratory, inflammation and autoimmunity.

In MedImmune's Phase 1, dose-escalation trial, patients will receive CAM- 3001 at Charite Research Organisation in Berlin, Germany across a range of escalating doses and will be monitored for up to seven months. Dose escalation will stop if maximum tolerated doses are reached.

CAM-3001, which was isolated and optimized at MedImmune's Cambridge, UK facility using its innovative display platform, inhibits GM-CSF signaling, which has the potential for a significant anti-inflammatory effect. There is substantial evidence for a role of GM-CSF in RA. In preclinical studies, CAM- 3001 has demonstrated potent inhibition of GM-CSF mediated effects in a range of in-vitro and in-vivo assays relevant to RA. Additionally, elevated levels of GM-CSF and its receptor have been found in the joints of patients with RA. This provides a strong rationale for the potential use of CAM-3001 to treat this debilitating d
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