Genmab A/S, a biotechnology company, reported that the last patient in the initial stage of the HuMax-CD4 Phase II trial for patients with active RA has completed the last treatment in the study. Genmab expects to release efficacy data from these 155 patients by the end of October 2002.
Genmab's HuMax-CD4 Phase II trial for 155 patients with RA in combination with methotrexate was launched in December 2000. The trial contains four active dose groups plus a placebo arm with the aim to collect efficacy and safety data as well as dose finding information. In June 2002 an extension to this study was announced. A further 65 patients are being accrued in order to collect additional pharmacokinetic data to support the ongoing development program. Study data that includes these extra 65 patients is expected to be available in Q1 2003.
"The teamwork of Genmab employees means we are once again on target to meet our milestones and release data from the Phase II before the end of October," said Lisa N. Drakeman, Ph.D., chief executive officer of Genmab. "We all look forward to seeing the efficacy data for this product."
HuMax-CD4 is a high affinity human antibody that targets the CD4 receptor on T-lymphocytes. These cells are involved in promoting autoimmune disease and an antibody that targets them can be used for the treatment of several inflammatory diseases including rheumatoid arthritis and psoriasis.
HuMax-CD4 has been studied by Genmab in both RA and psoriasis clinical trials. A Phase III study was launched in December 2001 for RA patients who had previously failed treatment with TNFalpha blockers. A Phase IIa study with psoriasis patients was completed earlier this year and a Phase IIb trial for psoriasis patients is planned to be launched in the second half of 2002.