Gaithersburg, MD, August 6, 2001 -- MedImmune, Inc. (Nasdaq: MEDI) announced today that it has begun dosing rheumatoid arthritis patients with Vitaxin™ in a Phase I clinical trial. Vitaxin is an antibody that has the potential to inhibit the progression of a variety of diseases, including rheumatoid arthritis, psoriasis, psoriatic arthritis, and certain forms of cancer and eye disease. Vitaxin appears to work by binding to a specific integrin (avb3) expressed on a number of cells, such as newly forming blood vessels (angiogenesis), bone resorbing osteoclasts, and activated macrophages. Both angiogenesis and osteoclast-mediated osteolysis (bone destruction) are key elements involved in the development of rheumatoid arthritis.
"We are very pleased to begin our clinical development for Vitaxin in rheumatoid arthritis," said Dr. Ronald Wilder, director of clinical development at MedImmune. "We believe that Vitaxin may have the ability to impede the advancement of this disease by exerting both anti-angiogenic and anti-osteolytic effects through its blocking of avb3. The data we collect from this trial will complement the research effort we previously initiated with Vitaxin in the cancer arena."
The Phase I rheumatoid arthritis study is a randomized, double-blind, placebo-controlled, dose escalation trial to be conducted at eight sites in the U.S. and Canada. The trial has two parts that will each include 32 patients who will randomly receive one of four dose levels of MEDI-522 or placebo. The primary objective of this two part study is to evaluate the safety and tolerability of escalating single (Part A) and multiple (Part B) doses of Vitaxin in patients with active rheumatoid arthritis who are currently treated with methotrexate with or without additional anti-rheumatic drugs. Secondarily, this study will evaluate the pharmacokinetics, immunogenicity and potential therapeutic efficacy of Vitaxin.
Earlier this year, MedImmune initiated two studies with Vitaxin in cancer patients. In March, the company began a Phase I pharmacokinetic study with Vitaxin in patients with refractory solid tumors. In July, the company began a Phase I/II study in patients with advanced colorectal cancer.
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.