XBiotech has begun its European Phase III study using its novel cancer drug Xilonix™ for the treatment of colorectal cancer.

Xilonix is an antiobody works to block a number of processes that tumors use to grow and spread, such as potentially inhibiting the formation of tumor blood supply and new metastasis. Blocking tumor-related inflammation may also inhibit or reverse wasting and other illness associated with the malignancy. 

The double-blinded placebo controlled study is evaluating the use of the monoclonal antibody therapy designed to block chronic inflammation associated with malignant tumor growth. The treatment is reportedly aimed at reversing disease symptoms associated with disease progression and survival.

The company says novel surrogate endpoints used in the study were established through close collaboration with the European Medicines Agency (EMA) scientific advice committee. XBiotech claims that compared with traditional oncology study endpoints, these will enable faster and more informative evaluation of anti-cancer therapy in patients with advance disease. The results of the study, if completed successfully, will reportedly allow for full marketing approval for Xilonix among member states of the European Union. 

The study, headed by oncologist Dr. Tamas Hickish, is being simultaneously launched in a number of western and eastern European states. Hickish remarked, "The enthusiasm of patients and doctors for this study is very encouraging for the success of this trial and indicates Xilonix indeed targets an un-met medical need."

XBiotech is executing the study in collaboration with KCR, a contract research organization headed in Eastern Europe. Dr. Anna Baran, Chief Medical Officer at KCR, stated, "The oncology research community, including multiple investigators in this study, are looking forward to the scientific outcome of XBiotech's clinical trial," and added that "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."