Gaithersburg, MD, July 25, 2001 -- MedImmune, Inc. (Nasdaq: MEDI) announced today that it has begun dosing patients in a Phase I pharmacokinetic and pharmacodynamic (PK/PD) study of siplizumab (MEDI-507) in patients with psoriasis. This trial is the third in a series of clinical studies for siplizumab in psoriasis expected to be conducted in 2001. Siplizumab is a humanized monoclonal antibody that has the potential to selectively suppress the immune system.
"Our clinical evaluation of siplizumab in patients suffering with psoriasis continues to make excellent progress this year," said Dr. James F. Young, president, research and development. "In this study, we are focusing on a comprehensive analysis of the pharmacokinetic and pharmacodynamic profiles of the drug both by intravenous and subcutaneous administration. The data collected from this study will complement our current Phase II program."
The PK/PD study is an open-label, five arm, single dose study Phase I trial being conducted at two sites in the U.S. A total of 25 patients with plaque psoriasis involving at least 10 percent of body surface area will be enrolled to receive a single intravenous or subcutaneous doses of siplizumab. The study is designed to analyze the pharmacokinetic and pharmacodynamic profile of siplizumab administered by intravenous infusion or subcutaneous injection, and to evaluate the safety and tolerance of the drug in otherwise healthy adults with plaque psoriasis.
The company recently announced that they had initiated Phase II testing of siplizumab in patients with psoriasis. The first Phase II study with siplizumab is being conducted at 25 sites in North America. In this randomized, double-blind, placebo-controlled trial, which is now completely enrolled, approximately 120 patients are being dosed intravenously. The second Phase II study is a randomized, double-blind Phase II trial currently enrolling at 20 sites in Europe. Approximately 120 patients will be enrolled to receive subcutaneous injections of siplizumab.
Psoriasis is a chronic illness affecting approximately two percent of the American population. Annual outpatient costs for psoriasis management have been estimated to be more than $1 billion. T-cells are an essential part of the pathophysiology of psoriasis, and it is believed that modulation of T-cell activities may be therapeutically advantageous in the treatment of psoriasis. MEDI-507 is a humanized monoclonal antibody that binds to the CD2 receptor found on the surface of T-cells and natural killer (NK) cells. By binding to CD2, MEDI-507 selectively suppresses the function of T-cells and NK cells.
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.