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Karolinska Institute, Stockholm

Subcutaneous MabCampath(R)/Campath(R) Highly Effective In Previously Untreated CLL Patients

Stockholm, Sweden (ots)

Subcutaneous administration of the first
and only monoclonal antibody, MabCampath(R)/Campath(R) (alemtuzumab),
approved for treatment of fludarabine refractory B-cell chronic
lymphocytic leukemia (B-CLL) patients (33 percent response), elicited
an overall response of 87 percent in previously untreated CLL
patients, according to the results of a Phase II study led by Anders
Osterborg, Associate Professor of Oncology at Karolinska Hospital and
Institute and published in the August 1, 2002 issue of Blood, the
Journal of the American Society of Hematology.
"This phase 2 study shows that subcutaneous treatment with
MabCampath(R)/Campath(R) appears to be a highly effective first line
treatment in patients with B-CLL," said Dr. Osterborg. "Furthermore,
subcutaneous administration of MabCampath(R)/Campath(R) also showed
tolerability benefits for patients, inducing very few of the flu-like
symptoms associated with intravenous monoclonal antibody treatment.
Injection-site skin reactions were transient and infections were
rare. Most of the "first-dose" reactions, which are frequently seen
after i.v. administration of alemtuzumab, were rare or absent in this
study. In addition, MabCampath(R)/Campath(R) appeared in this study
to have an appropriate infectious safety profile, provided that
antibiotic prophylaxis is used and the patients are closely
observed."
In commenting on the significance of the results, Dr. Osterborg
noted, "The overall response rate of 87 percent was supported by
impressive results seen at individual disease sites. The complete
response in blood was 95 percent. In addition, 87 percent of patients
achieved response in the lymph nodes. And in bone marrow, the primary
site of disease, the overall response was 79 percent, 45 percent
complete response. The reason for such dramatic effect in bone marrow
is thought to be the study's prolonged treatment of up to 18 weeks."
The open phase II trial was conducted at four clinics at the
Karolinska Institute, Stockholm, Sweden. Prophylactic treatment with
aciclovir, cotrimoxazole, and fluconazole was given. At the study's
completion the median time to treatment failure had not been reached,
but it was more than 18 months with a range of seven to 44.
B-Cell Chronic Lymphocytic Leukemia (B-CLL)
B-CLL is the most prevalent form of adult leukemia, annually
affecting approximately 60,000 people in the United States and 60'000
in Europe. The disease is most commonly diagnosed in people age 50
and older. CLL is characterized by the accumulation of functionally
immature white blood cells (lymphocytes) in the bone marrow, blood,
lymph tissue, and other organs. Two types of lymphocytes are present
in the blood, B cells and T cells. About 95 percent of CLL cases
involve cancerous B cells. Because these B cells have a longer than
normal life span, they begin to build up and "crowd out" the normal,
healthy blood cells. The accumulation of functionally immature cells
in the bone marrow excludes the generation of healthy cells and can
become fatal. Symptoms include fatigue, bone pain, night sweats, and
decreased appetite and weight loss, but bone marrow involvement also
leads to weakening of the immune system, exposing the patient to a
higher risk of infection.
MabCampath(R)/Campath(R) (alemtuzumab)
MabCampath(R)/Campath(R) is the first and only humanized
monoclonal antibody approved for CLL and the first drug with proven
efficacy in CLL patients who have failed both alkylating agents and
Fludara treatment. No other therapy has shown comparable efficacy in
this group of patients. MabCampath(R)/Campath(R) has a completely
different mode of action compared with conventional therapy by
selectively targeting the CD52 antigen on the malignant lymphocytes.
This activates processes leading to lysis, the death of the malignant
cells. These processes result in the removal of the malignant
lymphocytes from the bone marrow, blood, and other affected organs,
which in turn can lead to an increase in life expectancy.
MabCampath(R)/Campath(R) demonstrates a side effect profile that
can be safely managed with appropriate prophylaxis against and
monitoring for, opportunistic infections. Patients can form their own
healthy blood cells once again as MabCampath(R)/Campath(R) does not
attack the stem cells in the bone marrow.

Contact:

Jennifer Brendel
Phone: +1/212-299-8985
mailto:jennifer.brendel@pr21.com