Gaithersburg, MD, April 2, 2001 -- MedImmune, Inc. (Nasdaq: MEDI) announced today that it has begun dosing patients in a Phase II clinical trial of MEDI-507 in psoriasis patients. MEDI-507 is a humanized monoclonal antibody that has the potential to selectively suppress the immune system.
“Based on the encouraging preliminary results seen in our initial Phase I and Phase I/II trials with MEDI-507, we are moving forward into a broad commercial development program in psoriasis patients,” said Dr. James F. Young, president, research and development. “We are now dosing patients in our first Phase II trial of MEDI-507 in North America. We are also in the process of recruiting patients for a Phase II study in Europe and have two additional Phase II trials planned to begin later this year.”
The current North American study is a randomized, double-blind, placebo-controlled Phase II trial being conducted at approximately 25 sites in the U.S. and Canada. Over 100 patients who have plaque psoriasis involving at least 10 percent body surface area will be enrolled. The study will evaluate both the potential of MEDI-507 to affect the psoriatic disease of these patients, as measured by PASI (Psoriasis Area and Severity Index) score, and the side effect profile of the drug.
MedImmune also announced that it plans to submit abstracts for potential presentation of MEDI-507 data from three Phase I and Phase I/II studies at the International Psoriasis Symposium and European Congress on Psoriasis (June 19 – 24, 2001; San Francisco) and at the European Society of Dermatological Research Meeting (September 20 – 22, 2001; Stockholm, Sweden). The MEDI-507 studies for which MedImmune hopes to present data 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.
Dr. Young added, “We look forward to presenting the results from our initial trials with MEDI-507 in psoriasis at medical meetings later this year. Further, we expect to conclude our Phase II program with MEDI-507 around the end of this year. The data from this program will be used to make key decisions about proceeding into Phase III development.”
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