MedImmune Initiates First Clinical Trial of Mon...

GAITHERSBURG, Maryland, November 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 (LSE: AZN.L, NYSE: AZN). For more
information, visit MedImmune's website at http://www.medimmune.com.



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