Completes Enrollment in European Study and Completes Dosing in Previous North American Study
Gaithersburg, MD, September 17, 2001 -- MedImmune, Inc. (Nasdaq: MEDI) announced today that it has begun dosing psoriasis patients with siplizumab (MEDI-507) in a large Phase II clinical trial. This trial, which is to enroll approximately 400 patients at 50 sites in the United States and Canada, is a part of MedImmune's planned, comprehensive development program for siplizumab. By the end of 2001, MedImmune expects to have enrolled approximately 750 patients in seven clinical studies with siplizumab.
"We are pleased to initiate this study as a part of our broad development program for siplizumab," said Dr. Christine Dingivan, director of clinical development at MedImmune. "From the clinical trials currently underway, we are collecting data related to the drug's safety, efficacy, dosing, and durability of response. Should these trials continue to produce positive results, we expect to initiate our Phase III program in the early part of 2002."
The new Phase II study is a randomized, double-blind, placebo-controlled trial in which approximately 400 patients with plaque psoriasis on at least 10 percent of their body surface area and a minimum PASI (Psoriasis Area and Severity Index) score of 8 will receive subcutaneous injections of siplizumab. The study will compare the potential efficacy of different dosing regimens of MEDI-507, as measured by PASI score, as well as assess the drug's safety.
MedImmune also announced the completion of two important steps in two previously announced Phase II studies. In an intravenously dosed study initiated in March 2001 and conducted at approximately 25 sites in North America, the company announced that dosing of all 124 patients was now complete. Further, the company announced that enrollment of 121 patients was complete in a subcutaneously dosed study initiated in June 2001 at approximately 20 sites in Europe.
MedImmune is expected to present new safety and efficacy data from three additional Phase I and Phase I/II studies on September 20-22, 2001 in Stockholm, Sweden at the European Society of Dermatological Research Meeting.
Siplizumab 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, siplizumab selectively suppresses the function of T-cells and NK cells. 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. Psoriasis is a chronic illness affecting as many as 6 million Americans. Annual outpatient costs in the U.S. for psoriasis management have been estimated to be more than $1 billion.
MedImmune acquired exclusive worldwide rights to siplizumab from BioTransplant Incorporated (Nasdaq: BTRN) in 1995. Siplizumab is the humanized form of BioTransplant's murine monoclonal antibody, BTI-322. BioTransplant has retained the right to use BTI-322 and/or siplizumab in its proprietary ImmunoCognance(TM) systems, which are designed to re-educate the immune system to accept foreign tissue: the AlloMune(TM) System for human-to-human transplantation, and the XenoMune(TM) System for porcine-to-human transplantation. BTI-322 was initially discovered by Drs. Hervé Bazin and Dominique Latinne at the Experimental Immunology Unit of the Catholic University of Louvain in Belgium.
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.