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Two Phase II Clinical Trials Initiated for Vitaxin
GAITHERSBURG, Md., Sept. 9 /PRNewswire-FirstCall/ -- MedImmune, Inc. announced today the initiation of two Phase 2 clinical trials for Vitaxin, a development-stage monoclonal antibody. In one trial, the company is evaluating the anti-tumor activity and safety of Vitaxin in patients with metastatic melanoma (skin cancer). In the second trial, MedImmune is studying the affect Vitaxin has on disease activity and the progression of structural joint damage in patients with rheumatoid arthritis (RA).
"As an antibody that targets the alpha-v-beta-3 integrin, a protein implicated in the advancement of a number of our targeted diseases, we believe that Vitaxin may be instrumental in inhibiting the advancement of life- threatening cancers and some life-altering inflammatory diseases," said Dr. Edward Connor, MedImmune's senior vice president, clinical development. "Initiating these first Phase 2 trials is an important step in our comprehensive clinical development plan for Vitaxin, which also includes Phase 2 studies in prostate cancer and psoriasis."
Vitaxin is being developed for various indications in both cancer and inflammatory disease. It targets the alpha-v-beta-3 integrin, which is a protein expressed on the surface of newly forming blood vessels and certain tumor types, as well as on a number of cell types, including macrophages and osteoclasts. As such, alpha-v-beta-3 is implicated in a number of disease processes, including the growth and metastasis of tumors, as well as in the damage done to bone in RA.
Phase 2 Melanoma Trial
MedImmune's Phase 2 melanoma trial is a randomized, open label study involving 110 patients with stage IV metastatic melanoma at more than 20 sites in the United States. The trial will examine the safety and anti-tumor activity of Vitaxin. In the study, patients will receive weekly intravenous infusions of Vitaxin at a dose of 8.0 mg/kg either alone or in conjunction with dacarbazine, administered once every three weeks at a dose of 1,000 milligram per meter squared.
Malignant melanoma, the most serious form of skin cancer, is now the tenth most common cancer in the U.S., responsible for nearly 80 percent of all deaths from skin cancer. It is the fastest rising form of cancer among men and the second-fastest form among women. When melanoma is diagnosed at the earliest stage, five-year survival rates may approach 85 percent. Once tumors have metastasized, the survival rate declines precipitously.
Phase 2 Rheumatoid Arthritis Trial
MedImmune's Phase 2 RA trial is a randomized, double-blind, placebo- controlled study involving 300 patients with active RA who are responding suboptimally to methotrexate at approximately 70 multi-national sites. The trial will examine the safety and effect of subcutaneously administered Vitaxin on disease activity and the progression of structural joint damage. In this study, patients will receive weekly subcutaneous doses of Vitaxin at 4.0 mg/kg or placebo for six months followed by an open-label six-month treatment extension.
Rheumatoid arthritis is a chronic, progressive, autoimmune, inflammatory disease that may result in severe joint destruction, disability, and premature mortality. RA occurs in about one percent of the U.S. population and results in more than nine million doctor visits and 250,000 hospitalizations annually.
Source: MedImmune, Inc.