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Investigational New Drug Application for HuMax-CD20 To Treat Chronic Lymphocytic Leukemia Accepted
COPENHAGEN, Denmark, June 21 /PRNewswire-FirstCall/ -- Genmab A/S announced today the US Food & Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to start an open-label dose escalation Phase I/II study with HuMax-CD20 to treat patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL).
A total of 32 patients will be treated for four weeks and will initially receive either a 100 mg, 300 mg or 500 mg dose of HuMax-CD20, followed by three weekly doses of 500 mg, 1000 mg or 2000 mg, respectively. The highest dose group treated will be expanded to include a total of 26 patients in order to obtain more information about efficacy. The total follow up period is 12 months from treatment start and the primary endpoint of the trial is objective response over the period from screening to week 19. Genmab will initiate the study during the summer of 2004.
HuMax-CD20 is a human antibody which is effective at binding to the disease target, and releases only very slowly from the target over time. In February 2003, Genmab presented data from pre-clinical laboratory tests showing HuMax-CD20 appeared to kill tumor cells from cancer patients who had CLL that were resistant to rituximab, a marketed cancer therapy. The data showed the antibody highly effective in inducing complement mediated cytotoxicity (cell destruction) of B- cell tumors. Subsequently, Genmab has collected data that appears to show HuMax-CD20 is also effective in inducing Natural Killer cell-mediated cytotoxicity of B-cell tumors. Further, in a 92 day primate study, HuMax-CD20 effectively depleted B-cells from blood and lymph nodes. In this study, HuMax-CD20 appeared to deplete B-cells for a period of time that was four times longer than rituximab.
In another study it was found that HuMax-CD20 binds to a unique site on CD20 target cells when compared to other known CD20 antibodies. This is a distinguishing characteristic of HuMax-CD20 and may help explain why HuMax- CD20 has outperformed other CD20 antibodies in a variety of pre-clinical studies. Furthermore, in a novel cancer disease model in immuno-compromised mice using sensitive bio-luminescence imaging, new data show that HuMax-CD20 appears to stop growth of B-cell tumors grown from a laboratory cell line far more effectively than either placebo, or rituximab.
HuMax-CD20 is currently in an ongoing Phase I/II study to treat patients with relapsed or refractory follicular lymphoma.
The CD20 antigen is a transmembrane protein on pre-B and mature B lymphocytes. CD20 appears to act as a calcium ion channel, and to regulate early steps in B lymphocyte activation. The molecule is not shed from the cell surface, and is not internalized upon antibody binding. CD20 is found on over 90% of B-cell lymphomas, as well as other lymphoid tumors of B-cell origin.
About Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia is the most common leukemia in adults in the US and most of Western Europe. The incidence is 8,100 to 12,500 new cases in the US per year and 85-95% of the cases are of B-cell origin. CLL is a subgroup of Non-Hodgkin's lymphoma (NHL) and together with small lymphocytic lymphoma (SLL) corresponds to around 20% of all NHL cases.
Source: Genmab A/S