XBiotech expands Phase III trial in Europe using Xilonix to treat metastatic colorectal cancer

XCITE is an FDA fast tracked, pivotal Phase III trial of the company’s cancer drug Xilonix.

XCITE is designed to assess improvement in overall survival of patients in response to monotherapy with XBiotech’s True Human monoclonal antibody.

The company noted that screening has now started at the Marii Sklodowskiej-Curie Oncology Center in Warsaw, Poland, marking the first patient recruitment site outside the US and the commencement in earnest of the global phase of the FDA study.

The double-blinded, placebo controlled trial currently has about 98 sites in the US and with this launch in Poland, will bring on line more than 80 sites across Eastern and Western Europe.

The trial will continue to expand to include nearly 200 clinical sites across 20 countries across the world including Australia, Canada and South America.

XBiotech medical director Dr Michael Stecher said: "Our on-time launch of XCITE into Europe marks an important milestone in our oncology program and signifies we are moving as planned toward completing enrollment by the end of 2016.

"Since we have been operating another Phase III oncology program in colorectal cancer in Europe, it was important to time the launch of the U.S. FDA study into Europe so as not to compete for patient enrollment.

"Our clinical operations team has managed to dovetail this important study with impeccable timing to coincide almost precisely with the completion of the European Phase III program.

"We expect the rapidly escalating engagement we have seen with our European study will now spill over to this new program, which gives us good confidence that we will achieve our enrollment objectives in 2016 as well as report interim survival data around the time of enrollment completion."

Enrolment of a total of 600 patients in this trial will be will be completed by the end of 2016.