Denmark’s Genmab says that it has started Phase I/II studies of its investigational compound zalutumumab as a potential treatment for colorectal cancer.
The trial will combine zalutumumab, also known as HuMax-EGFr, with irinotecan on up to 97 patients who have failed standard chemotherapy and progressed during or within three months of stopping cetuximab-based therapy. Safety data from the first part of the trial will be evaluated by an independent committee which will determine if it is safe to begin part two.
“We are glad to expand the zalutumumab programme with this new indication,” Genmab chief executive Lisa Drakeman noted. The company also reported that to date, 132 patients have been dosed in a Phase III study of HuMax-EGFr to treat head and neck cancer patients considered incurable with standard therapy.
Survival is the primary endpoint of the latter study and an interim analysis will take place at some stage this year.
The news comes just as Genmab posted an operating loss of 197 million Danish kroner, or around $42 million, for the first quarter, a rise of 85.8%. The increase was due principally to a 106% rise in its R&D spend to 328 million kroner.
Sales increased to 167 million kroner from 80 million kroner and the firm reiterated its full-year guidance for an operating loss of 900 million-1 billion kroner and revenues of around 1 billion kroner.
