MedImmune, Inc.
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
medimmune.
MedImmune Inc.
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