Genmab's HuMax-CD4 receives US orphan drug designation

Published: 25-Aug-2004

Danish biotech company Genmab's HuMax-CD4 for the treatment of Mycosis Fungoides (MF), which constitutes 75% of all cutaneous T-cell lymphomas (CTCL), has been designated an orphan drug by the US FDA.


Danish biotech company Genmab's HuMax-CD4 for the treatment of Mycosis Fungoides (MF), which constitutes 75% of all cutaneous T-cell lymphomas (CTCL), has been designated an orphan drug by the US FDA.

HuMax-CD4 is a high affinity human antibody that targets the CD4 receptor on T-lymphocytes. Genmab has run two Phase II studies using HuMax-CD4 to treat CTCL, one in early stage patients and the other for patients with advanced disease, both of which achieved positive results. Planning for the pivotal study with MF patients is underway.

'HuMax-CD4 has now been granted orphan drug status in both the US and Europe,' said Dr Lisa N. Drakeman, ceo of Genmab. 'This designation highlights the importance of HuMax-CD4 as a potential new treatment for CTCL.'

  

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