Monday September 24, 9:26 am Eastern Time
Press Release
SOURCE: MedImmune, Inc.
Clinical Data for Siplizumab Presented at European
Psoriasis Meeting
GAITHERSBURG, Md., Sept. 24 /PRNewswire/ -- MedImmune, Inc. (Nasdaq: MEDI - news) announced today that data
from its initial clinical studies with siplizumab (MEDI-507) as a potential treatment for psoriasis were presented at the European
Society of Dermatological Research, held in Stockholm, Sweden, September 21-22, 2001. The presentation built upon
preliminary data described in June at the International Psoriasis Symposium and European Congress on Psoriasis, providing
longer-term safety analysis for two trials using intravenous administration and new clinical data for a trial using subcutaneous
administration. Overall in these studies, siplizumab was found to be generally well tolerated, and was shown to improve
psoriatic disease, as measured by PASI (Psoriasis Area and Severity Index) score, via both intravenous and subcutaneous
administration. The follow-up period confirmed the preliminary safety and clinical results, and showed that improvement in
patients' psoriasis appeared to be durable after completion of treatment.
``We are encouraged by the complete results of these initial trials with siplizumab,'' commented Dr. Christine Dingivan, director
of clinical development at MedImmune. ``The new data provides additional insight into the drug's activity, as well as the
durability of clinical outcomes in patients suffering from moderate-to-severe psoriasis. With these trials now complete, our focus
is on collecting and analyzing data from our broad Phase II program in which we are dosing patients at approximately 95 sites
in North America and Europe.''
Data presented came from three studies:
* 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.
* 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.
Data from the additional safety follow-up period supports the safety profile of siplizumab. Side effects were generally mild,
transient and occurred less frequently with subsequent doses, and most commonly included chills, headache, and decreased
heart rate. Dose-dependent reductions in mean absolute lymphocyte counts were smaller with subcutaneous administration and
correlated to clinical outcome. Overall, with regard to the changes in lymphocyte counts, the incidence, type or severity of
adverse events did not reflect clinical evidence of immune suppression.
Improvement in psoriasis, as measured by PASI score, remained consistent with the preliminary analysis presented in June
2001. Improvement was observed in all dose groups studied and was most notable among patients at the highest dose levels
(0.04 mg/kg intravenous dosing and 5.0 mg and 7.0 mg subcutaneous dosing), where approximately 39 percent of the patients
showed at least a 75-percent improvement in PASI score, and approximately 56 percent experienced at least a 50-percent
improvement. Overall, 70 percent of the patients treated experienced at least 25-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 has a comprehensive Phase II development program underway with siplizumab. Currently, the company has three
active Phase II trials: a randomized, double-blind, placebo-controlled, subcutaneous administration trial involving 400 patients
at approximately 50 sites in North America (enrollment ongoing); a randomized, double-blind, placebo-controlled, intravenous
administration trial involving 124 patients at approximately 25 sites in North America (dosing complete); and a randomized,
double-blind, subcutaneous administration trial involving 121 patients at approximately 20 sites in Europe (enrollment
complete).
MedImmune acquired exclusive worldwide rights to siplizumab from BioTransplant Incorporated (Nasdaq: BTRN - news) 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. |
