Press Release
European Medicines Agency Grants Eligibility for Submission of XBiotech’s Marketing Authorization Application (MAA)
In a recently concluded Phase III study in the EU, patients treated with the antibody therapy Xilonix had failed all conventional therapies and had inoperable or metastatic disease. Patients were also required to have multiple symptoms of disease—each of which correlated with poor prognosis. Treatment of these advanced colorectal cancer patients indicated that the Xilonix antibody therapy was able to control tumour-related symptoms associated with morbidity and death. Furthermore, the Phase III study indicated that Xilonix therapy appears to lack the frank toxicity of many other anti-cancer agents, and that the therapy may not cause the negative hematological effects that result in immunosuppression, eliminating a troubling toxicity and life-threatening risk factor of other anti-cancer therapies used to treat advanced disease.
In the advanced cancer patients treated in this recently completed Phase III study for Xilonix, there was a 76% relative improvement in response rate in patients treated with the antibody, as compared to placebo (p=0.0045). Secondary endpoints used in the Phase III study—control of thrombocytosis and systemic inflammation—which are known prognosticators of overall survival, were also significantly improved in the treated patients compared to controls (respectively p=0.003, p=0.004). In addition to these planned analyses, the study revealed a higher incidence of stable disease in the antibody-treated patients, and there were fewer significant adverse events (SAEs) in the treatment arm than in the placebo group.
The Company believes that the recent and earlier clinical findings to be presented in its MAA provide a compelling case for the clinical benefit of the antibody therapy and establish Xilonix as a groundbreaking therapy for advanced colorectal cancer.
Few agents are reliably able to mediate durable responses in metastatic disease; and many agents have significant trade-offs in terms of side effects, such that the overall benefit of therapy may be questionable in patients with advanced cancer. Based on novel objective response (OR) criteria, developed by
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Contact:XBiotech Ashley Otero aotero@xbiotech.com 512.386.2930