XBiotech begins patient enrollment in Phase III trial of Xilonix to treat colorectal cancer

The double-blinded, placebo controlled trial is evaluating the use of the monoclonal antibody therapy designed to block chronic inflammation associated with malignant tumor growth.

According to the company, the treatment is reportedly aimed at reversing disease symptoms associated with disease progression and survival.

New surrogate endpoints used in the trial were established through close collaboration with the European Medicines Agency (EMA) scientific advice committee.

Compared to traditional oncology study endpoints, the new surrogate endpoints will enable faster and more informative evaluation of anti-cancer therapy in patients with advance disease.

If completed successfully, the results of the trial will reportedly allow for full marketing approval for Xilonix among member states of the European Union (EU).

Headed by oncologist Dr Tamas Hickish, the trial is being simultaneously launched in a number of western and eastern European states.

The company is executing the Phase III trial in collaboration with KCR, a contract research organization headed in Eastern Europe.

KCR chief medical officer Dr Anna Baran said the oncology research community, including multiple investigators in this trial, are looking forward to the scientific outcome of XBiotech’s clinical trial.

"The novel approach targeting IL-1 pathway is extremely interesting for all stakeholders, not only in the advanced colorectal cancer population, but also in other advanced cancer settings," Baran said.