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HuMax-CD4 To Enter Phase III Studies.(Brief Article)
2002 JAN 9 - (NewsRx.com & NewsRx.net) -- Genmab A/S announced that it has received permission from the U.S. Food and Drug Administration (FDA) to begin a Phase III study with HuMax-CD4 to treat patients with active rheumatoid arthritis (RA) who have failed to respond to treatment with methotrexate and tumor necrosis factor (TNF)-(alpha) blocking agents.
These patients represent a major unmet medical need, as they do not have an effective treatment option. The objective of the Phase III trial is to confirm the safety and efficacy of HuMax-CD4 in the treatment of RA. It will enroll 400 patients who will be treated with either 80 or 160 mg of HuMax-CD4 or placebo for a total of 26 weeks.
The patients will be given two doses, two weeks apart, followed by one dose each month. The Phase III trial will be initiated in the U.S. and Europe in December 2001, and is planned to take place at over 50 sites.
To date, over 200 patients have been treated with HuMax-CD4, with the vast majority receiving multiple doses of the product. In previously reported studies, HuMax-CD4 has been safe and well tolerated and shown favorable responses in a Phase I/II RA study, where half the patients in the highest four dose groups achieved responses ranging from ACR 20 to ACR 70.
Genmab will manage this study with its substantial in-house product development team that includes clinical, regulatory and biometric groups in the U.S. and Europe. In addition to addressing the refractory RA market, Genmab plans additional Phase III studies in the broader indication of moderately to severely diseased patients. HuMax-CD4 is also being tested in psoriasis in Phase II studies.
HuMax-CD4 is a high affinity fully 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 ...
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...eventually could generate upwards of $1 billion annually in U.S. sales alone. In this first round of Phase Ill testing. HuMax-CD4 will be studied in patients suffering from active rheumatoid arthritis (RA) who have not responded to other treatments...
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Source: HighBeam Research, HuMax-CD4 To Enter Phase III Studies.(Brief Article)