Gaithersburg, MD, July 16, 2001 -- MedImmune, Inc. (Nasdaq: MEDI) 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) 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.
MedImmune, Inc. is a biotechnology company focused on developing and marketing products that address medical needs in areas such as infectious disease, immune regulation and cancer. Headquartered in Gaithersburg, Maryland, MedImmune has manufacturing facilities in Frederick, Maryland and Nijmegen, the Netherlands.
This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in the company's filings with the U.S. Securities and Exchange Commission. The company is developing several products for potential future marketing. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success.