Austin-based XBiotech recently announced in a press release that it has enrolled the first patient in the company’s European Phase III clinical trial of Xilonix, a first-in-class “True Human” monoclonal antibody targeting interleukin-alpha1 for the treatment of colorectal cancer, the third most commonly diagnosed cancer and the third leading cause of cancer death worldwide.
In 2013, the company had announced the beginning of a critical Phase III trial for Xilonix in the US. Now, the same study is being launched in various western and eastern European countries. Moreover, Xilonix had already been used in a study at MD Anderson Cancer Center, treating sixteen advanced non-small cell lung cancer patients, all of which had failed to achieve positive results from previous conventional therapies, and had progressive disease upon receiving the monoclonal antibody.
The European-based double-blinded placebo controlled trial will be headed by Dr. Tamas Hickish, a renowned oncologist, and aims to evaluate Xilonix’s efficacy in blocking chronic inflammation associated with cancer, thereby limiting the metastatic and angiogenic potential associated with tumor growth.
“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,” said Dr. Hickish.
The main objective of the treatment is to reverse disease symptoms associated with disease progression and survival, with novel surrogate endpoints established through collaboration with the European Medicines Agency’s (EMA) scientific advice committee, which seeks to enable faster and more informative evaluation of anti-cancer therapy in patients with advanced disease.
Furthermore, XBiotech is collaborating with KCR, a contract research organization headed in Eastern Europe, for the development of this trial.
“The oncology research community, including multiple investigators in this study, is 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,” said Dr. Anna Baran, Chief Medical Officer at KCR.
There are currently several patients waiting to enroll in the study, and if the trial proves to be successful, Xilonix could be fully approved for marketing among member states of the European Union.
Gary Gonzales, XBiotech’s Vice President of Clinical Operations said, “It is exciting to enter the enrollment phase of the trial with what appears to be a strong momentum. We hope that this will continue as additional countries are activated.”