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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) 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.
ots Originaltext: Karolinska Institute, Stockholm