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



11/26/2007 8:18:06 AM

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 disease.

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

In 2001, MedImmune's Cambridge facility (then known as Cambridge Antibody Technology) and AMRAD Operations Pty Ltd., now owned by CSL Limited, entered into a collaboration to jointly discover and develop human MAb therapeutics that neutralize the GM-CSF receptor, including CAM-3001. Under the terms of a subsequent licensing agreement entered into in August 2007, CSL will receive upfront 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 is associated with significant morbidity and mortality. The disease is characterized 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 associated with RA, especially the more severe forms of the disease. There is need for additional treatments to control moderate to severely active disease. A new treatment is needed that may provide a significant clinical benefit for disease remission, as well as inhibiting progressive joint damage, and improving quality of life in patients with RA.

About MedImmune

MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is dedicated to advancing science and medicine to help people live better lives and is wholly owned by AstraZeneca plc . For more information, visit MedImmune's website at http://www.medimmune.com.

CONTACT: Media, Jamie Lacey, +1-301-398-4035, or Investors, Peter Vozzo,
+1-301-398-4358, both of MedImmune Inc.

Web site: http://www.medimmune.com/


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