Gaithersburg, MD, June 6, 2001 -- MedImmune, Inc. (Nasdaq: MEDI) announced today that it has expanded the clinical development of MEDI-507 to include psoriasis patients in Europe. The company has begun dosing patients in its European Phase II study, the second in a series of Phase II studies for MEDI-507 expected to be conducted in 2001. MEDI-507 is a humanized monoclonal antibody that has the potential to selectively suppress the immune system.
“We continue to be pleased with the progress in our Phase II program for MEDI-507 in psoriasis,” said Dr. James F. Young, president, research and development. “This European study will further evaluate the safety and efficacy of a subcutaneous route of administration for MEDI-507. In addition, we expect to complement this investigative effort by initiating a focused pharmacokinetic/pharmacodynamic study very soon.”
The European study is a randomized and double-blind Phase II trial being conducted at 20 sites in Europe. Approximately 120 patients who have plaque psoriasis involving at least 10 percent body surface area and a minimum PASI (Psoriasis Area and Severity Index) score of 8 will be enrolled to receive weekly subcutaneous injections of MEDI-507. The study will evaluate both the potential of MEDI-507 to affect the psoriatic disease of these patients, as measured by PASI score, and the side effect profile of the drug.
MedImmune's first Phase II study with MEDI-507 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.
Data from MedImmune's Phase I program with MEDI-507 will be reviewed in an oral presentation at 12:30 p.m. on June 23, 2001 in San Francisco at the International Psoriasis Symposium and European Congress on Psoriasis. The MEDI-507 studies that will be included in the presentation include a Phase I, open-label, single-dose intravenous safety study; a Phase I/II, open-label, dose-escalation study involving 8-weekly intravenous infusions; and a Phase I/II, open-label, dose-escalation study involving 12-weekly subcutaneous injections. Reductions in PASI scores have been observed in these studies.
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.