Genmab A/S announced that the US FDA has approved the start of two Phase II open label studies using HuMax-CD4 to treat a form of cancer known as Cutaneous T-cell Lymphoma (CTCL).

Genmab will run two studies concurrently, each with an initial 12 patients.One study will focus on refractory patients and the other will be for patients with persistent early stage disease.In both studies patients will receive a 280 mg dose of HuMax-CD4 once a week for 16 weeks.Patients will be followed for at least four weeks after the end of treatment or until disease progression.The objective of the studies is to determine the efficacy and safety of HuMax-CD4 in the treatment of CTCL.

"There is an unmet medical need for therapies to help patients who suffer from CTCL, a disease that is both debilitating and eventually life threatening," said Lisa N. Drakeman, Chief Executive Officer of Genmab. "With these trials, we continue our work on products that may help patients who currently have a significant need for treatment alternatives."

T-cell lymphomas positive for the CD4 receptor constitute around 5% of Non Hodgkin's Lymphomas.

CTCL is one group of CD4+ lymphomas.This type of lymphoma expresses the CD4 receptor which can be targeted by Genmab's HuMax-CD4 antibody.CTCL is a highly symptomatic disfiguring disease which is life threatening in the advanced stages and is incurable except at its very earliest stages.