Danish biotechnology firm Genmab AS has amended the design of an ongoing study of HuMax-CD4 (zanolimumab) in refractory cutaneous T-cell lymphoma. The trial, which had previously only included patients with the mycosis fungoides form of the disease, will now recruit sufferers of Sezary syndrome, a second type of CTCL.
Additionally, as a result of the higher-than-expected response rates that have been observed in the 14mg/kg dose group, Genmab has decided to discontinue the 8mg/kg section of the trial. Lisa Drakeman, the company's chief executive, said that expansion of the program would expedite enrollment, in addition to providing more benefit to patients.
In related news, HuMax-CD4 has received Orphan Drug designations for refractory CTCL from regulators in Australia, and for refractory nodal T-cell lymphoma in Europe.
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