GENMAB AMENDS HUMAX-CD4 PIVOTAL STUDY IN CTCL
Receives Orphan Drug Designation for Nodal T-cell Lymphoma
Copenhagen, Denmark; October 11, 2007 - GenmabÂ announced today it has amended the design of the ongoing pivotal study of HuMax-CD4Â® (zanolimumab) to treat refractory cutaneous T-cell lymphoma (CTCL) patients. The study which previously only included patients with the Mycosis Fungoides (MF) form of CTCL has been expanded to include patients with SÃ©zary Syndrome as well. Furthermore, due to higher response rates observed at the 14 mg/kg dose level during the first part of the pivotal study, the 8 mg/kg dose level will now be discontinued, with all patients to be treated with 14 mg/kg of HuMax-CD4 once a week for 12 weeks.
These study amendments have been agreed to by the FDA under the Special Protocol Assessment agreement already in place.
In addition, HuMax-CD4 has received an orphan drug designation for the treatment of refractory CTCL in Australia and for the treatment of refractory nodal T-cell lymphoma in Europe. HuMax-CD4 previously received Fast Track Status from the FDA and orphan drug status in the US and Europe for the treatment of refractory CTCL.
"We believe expanding the HuMax-CD4 pivotal study to include a broader group of CTCL patients will allow us to speed up patient enrollment, test at a more effective dose level and potentially offer treatment for SÃ©zary Syndrome patients as well as MF patients," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "The potential of HuMax-CD4 in treating T-cell lymphoma patients with unmet medical needs continues to be recognized by the international regulatory authorities."