MedImmune Initiates First Clinical Trial of Monoclonal Antibody Targeting GM-CSFR in Patients with Rheumatoid Arthritis

Monday, November 26, 2007 General News
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GAITHERSBURG, Md., Nov. 26 MedImmune, Inc. today announcedthat 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 ofthe granulocyte-macrophage colony stimulating factor receptor (GM-CSFR). Thestudy is designed to evaluate the safety and tolerability of single doses ofCAM-3001 in patients with rheumatoid arthritis (RA), and represents the firstclinical trial in which a MAb targeting GM-CSFR is being investigated in thispopulation. MedImmune currently holds exclusive, worldwide rights to developand market CAM-3001 under an agreement with CSL Limited.

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

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

CAM-3001, which was isolated and optimized at MedImmune's Cambridge, UKfacility using its innovative display platform, inhibits GM-CSF signaling,which has the potential for a significant anti-inflammatory effect. There issubstantial 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 rangeof in-vitro and in-vivo assays relevant to RA. Additionally, elevated levelsof 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 treatthis debilitating disease.

About MedImmune's Anti-GM-CSFR Antibody Development Program

In 2001, MedImmune's Cambridge facility (then known as Cambridge AntibodyTechnology) and AMRAD Operations Pty Ltd., now owned by CSL Limited, enteredinto a collaboration to jointly discover and develop human MAb therapeuticsthat neutralize the GM-CSF receptor, including CAM-3001. Under the terms of asubsequent licensing agreement entered into in August 2007, CSL will receiveupfront and milestone payments, as well as royalties, on future sales of CAM-3001. Additional terms of the agreement have not been disclosed.

About Rheumatoid Arthritis

Rheumatoid arthritis is a chronic systemic inflammatory disease that isassociated with significant morbidity and mortality. The disease ischaracterized by inflammation of the synovial joints that can result in pain,swelling and joint damage with secondary deformity and progressive disability.Despite current treatment options, there is a significant mortality associatedwith RA, especially the more severe forms of the disease. There is need foradditional treatments to control moderate to severely active disease. A newtreatment is needed that may provide a significant clinical benefit fordisease remission, as well as inhibiting progressive joint damage, andimproving quality of life in patients with RA.

About MedImmune

MedImmune strives to provide better medicines to patients, new medicaloptions for physicians and rewarding careers to employees. With approximately3,000 employees worldwide and headquarters in Maryland, MedImmune is dedicatedto advancing science and medicine to help people live better lives and iswholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information,visit MedImmune's website at

SOURCE MedImmune Inc.

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