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news.Genmab A/S has reached agreement with the FDA under the special protocol assessment process on the design of its pivotal study protocol for HuMax-CD4 in lymphoma.
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The pivotal study, which will be carried out under an FDA fast track designation, will include patients with the most common form of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF), who are refractory to or intolerant of Ligand Pharmaceuticals’ Targretin and one other standard therapy.
The trial will consist of two stages. The first stage will be open-label and is designed to characterize in humans the new antibody material compared to that used in previous studies. Six patients in each dose level will receive 4mg/kg, 8mg/kg or 14mg/kg of HuMax-CD4. The second stage will be blinded and will include 70 patients randomized to either 8mg/kg or 14mg/kg of HuMax-CD4 once weekly for 12 weeks.
The primary endpoint of the clinical trial will be the complete and partial response rate during treatment and an eight week follow up period. Partial responses are defined as improvements of at least 50% in physician’s global assessment (PGA) score and complete responses are 100% improvements.
As Genmab has changed the manufacturer for HuMax-CD4 (zanolimumab) in order to prepare for potential commercial launch, Genmab agreed with the FDA to treat a total of 18 patients at three doses prior to treating the remaining 70 patients in a randomized manner at the two higher doses.