CLINICAL TRIAL ACTIVITIES

XBiotech has conducted a number of Phase I/II clinical trials for its lead product candidate Xilonix™. This remarkable therapeutic antibody targets and neutralizes a small protein substance produced by the body known as IL-1α. To date, multiple clinical trials testing Xilonix™ monotherapy have been conducted, including the treatment of late stage cancer, diabetes, vascular disease, acne and psoriasis. Results from these studies have formed the basis for USFDA Fast Track designations for the treatment of colorectal cancer, as well as for treatment of patients undergoing treatment for vascular disease. A Phase III pivotal study was launched in 2013 for the use of Xilonix™ in the treatment of advanced colorectal cancer with associated cachexia.


milestones



A short list of clinical milestones is shown on a timeline from 2010 through expected milestones over the near future. Notably, the timeline depicts XBiotech's launch of its True Human™ antibody therapy into human clinical trials for advanced cancer treatment in 2010 at MD Anderson Cancer Center in Texas. The most advanced program depicted is an ongoing Phase III Pivotal study that is headed by the Mayo Clinic in Rochester, Minnesota. This study involves over 100 clinical sites around the USA. Proof of concept clinical studies conduced in Type II diabetes, Psoriasis, and Acne have each yielded promising results to justify advancement of respective clinical programs. A second Phase III pivotal study in colorectal cancer, which is under development with the European Medicines Agency (EMA), is expected to commence in the first half of 2014. A possible breakthrough antibody therapy for drug resistant bacterial infections is expected to reach clinical development before the end of 2014.

List of Enrolling or Completed Clinical Studies*

Title
Enrolling
Completed
Study of MABp1 in patients with Advanced Cancers X
Study of CA-18C3 in Subjects with Advanced Hematologic Malignancies X
Open Label, Randomized Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of an Anti-Inflammatory Therapeutic Antibody (CV-18C3) in Reducing Restenosis in Patients Undergoing Percutaneous Femoro-Popliteal Revascularization X
Open Label Study of the Safety, Pharmacokinetics, and Efficacy of a True Human™ Anti-Inflammatory Therapeutic Antibody (RA-18C3) in Subjects with Moderate to Severe Plaque Psoriasis X
Study of the Safety and Pharmacokinetics of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients with Type 2 Diabetes Mellitus X
Open Label Study of the Safety, Pharmacokinetics, and Efficacy of a True Human™ Anti-Inflammatory Therapeutic Antibody (RA-18C3) in Subjects with Moderate to Severe Acne Vulgaris X
A Pivotal Phase III Study to Evaluate Overall Survival using MABp1 as a Monotherapy in Metastatic Colorectal Cancer Patients with Cachexia X
A Phase II Open Label Study of RA-18C3 in Subjects with Pyoderma Gangrenosum X

*The MABp1 anti-IL-1α therapeutic antibody has been assigned different names depending on the clinical indication, such as MABp1, Xilonix™, CA-18C3, CV-18C3, RA-18C3, T2-18C3, etc. Each of these, however, contain the same True Human™ antibody MABp1.