>>GAITHERSBURG, Md., Jul 16, 2001 /PRNewswire via COMTEX/ -- MedImmune, Inc. (Nasdaq: MEDI chart, msgs) announced today that it has begun dosing colorectal cancer patients with Vitaxin in a Phase I/II clinical trial. Vitaxin is an antibody that has the potential to inhibit the growth of new blood vessels (angiogenesis) by binding to a specific integrin (AvB3) expressed on a variety of cells that play a critical role in inflammatory diseases such as rheumatoid arthritis and restenosis, as well as cancer.
"We are very excited to start this new clinical trial," said Dr. James F. Young, MedImmune's president, research and development. "Colorectal cancer is an important therapeutic target for Vitaxin since there is still significant unmet medical need. We believe that AvB3 may be a critical target in controlling the advancement of this disease."
The Phase I/II cancer study is a two-part study in patients with advanced colorectal cancer. Phase I of the study is an open-label, single-center, dose escalation trial that will enroll 16 patients and evaluate the safety of Vitaxin in colorectal cancer patients and determine a recommended Phase II dose. Phase II of the study is dependent upon successful completion of Phase I. Phase II is also an open-label trial, involving 40 patients with advanced colorectal cancer, which will evaluate the antitumor activity of Vitaxin.
In March 2001, MedImmune initiated a Phase I pharmacokinetic study with Vitaxin in patients with refractory solid tumors. This ongoing study is a non-randomized, open-label, dose-escalating trial that will enroll as many as 24 patients with various refractory solid tumors. The objectives of the study are to determine the safety and pharmacokinetics of single and multiple doses of Vitaxin when administered intravenously in cancer patients. In this study, Vitaxin will be administered intravenously at up to six dose levels.
MedImmune licensed Vitaxin from Applied Molecular Evolution, Inc. (Nasdaq: AMEV chart, msgs) in February 1999. During 2000, the two companies worked together to prepare a more potent version of the original Vitaxin molecule using AME's proprietary technology. <<
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