Saturday June 23, 2:45 pm Eastern Time
Press Release
SOURCE: MedImmune, Inc.
Initial Clinical Results for MEDI-507 as Psoriasis
Treatment Presented at International Psoriasis
Symposium
GAITHERSBURG, Md., and CHARLESTOWN, Mass., June 23 /PRNewswire/ -- MedImmune, Inc. (Nasdaq: MEDI -
news) and BioTransplant Incorporated (Nasdaq: BTRN - news) announced today that the initial clinical data for MEDI-507
(siplizumab) as a potential treatment for psoriasis was presented at the International Psoriasis Symposium and European
Congress on Psoriasis, held in San Francisco, June 19-24, 2001. Results from three clinical trials conducted by MedImmune
with siplizumab showed that the drug was generally safe and well tolerated. Patients experienced improvement in psoriasis, as
measured by PASI (Psoriasis Area and Severity Index) score via both intravenous and subcutaneous routes of administration.
Further, preliminary follow-up data indicates that improvement in patients' psoriasis appears to be durable following completion
of treatment.
``We are pleased that siplizumab appears to be safe and well tolerated and is having a clinically meaningful and durable impact
on patients' psoriatic disease,'' said James F. Young, Ph.D., MedImmune's president, research and development. ``We
currently have a broad Phase II program underway and expect to provide additional data from our Phase I program later this
year at the European Society of Dermatological Research Meeting to be held September 20 - 22, 2001 in Stockholm,
Sweden.''
Studies presented Saturday June 23, 2001 at the International Psoriasis Symposium included:
* a Phase I, open-label, single-dose intravenous safety study involving
14 moderate-to-severe psoriasis patients who were given 0.0004 mg/kg,
0.0012 mg/kg, 0.004 mg/kg, or 0.012 mg/kg of siplizumab;
* a Phase I/II, open-label, dose-escalation study involving
26 moderate-to-severe psoriasis patients who received up to 8 weekly
intravenous infusions of siplizumab at 0.0012 mg/kg, 0.004 mg/kg,
0.012 mg/kg or 0.04 mg/kg; and
* a Phase I/II, open-label, dose-escalation study involving
39 moderate-to-severe psoriasis patients who received up to 12 weekly
subcutaneous injections of siplizumab at 0.1 mg, 0.3 mg, 1.0 mg,
3.0 mg, 5.0 mg or 7.0 mg.
In all three studies, siplizumab was found to be generally safe and well tolerated. Side effects were generally considered mild
and most commonly included chills and headache in the intravenous studies, and minimal injection site reaction, chills, and
headache in the subcutaneous study. Reductions in targeted lymphocyte populations were dose-dependent and less significant
when siplizumab was administered subcutaneously.
Improvement in psoriasis, as measured by PASI score, was observed in all dose groups studied and was most notable among
patients at the highest dose levels. Overall, more than 70 percent of all patients treated experienced at least 25-percent
improvement in PASI score. At the highest dose groups (0.04 mg/kg in the intravenous studies or 5.0 mg and 7.0 mg in the
subcutaneous study) more than 55 percent of patients experienced at least a 50-percent improvement, while more than 33
percent showed at least a 75-percent improvement in their disease.
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 for psoriasis management have been estimated to be more than $1 billion.
MedImmune initiated its Phase II development program with siplizumab earlier this year. Currently, the company has two active
Phase II trials underway: a randomized, double-blind, placebo-controlled, intravenously dosed Phase II study being conducted
at approximately 25 sites in North America involving 124 moderate-to-severe psoriasis patients; and a randomized, double-
blind, subcutaneously dosed Phase II trial being conducted at approximately 20 sites in Europe involving approximately 120
moderate-to-severe psoriasis patients.
MedImmune acquired exclusive worldwide rights to siplizumab from BioTransplant 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. Herve 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.
SOURCE: MedImmune, Inc.
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