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XBiotech Provides First Quarter 2016 Corporate and Clinical Update
Conference Call and Webcast today,
European Medicines Agencyaccepts Marketing Authorization Application for Xilonix™ in colorectal cancer and grants accelerated review
- Xilonix Phase III U.S. trial enrollment on schedule
- Novel antibody to treat all forms of S. aureus infections, including MRSA, advances to Phase II, Phase I completed
- New manufacturing facility nearing completion
- Key additions to leadership team
In a pivotal Phase III clinical study, Xilonix was shown to control tumor-related symptoms associated with morbidity and death. These data will be presented for the first time at the 18th European Society of Medical Oncology’s
Simard said enrollment is on track for a separate pivotal Phase III trial of Xilonix in advanced colorectal cancer that is part of the FDA’s Fast Track program.
Xilonix is specifically designed to target and neutralize interleukin 1-alpha, a protein that has been shown to promote the growth and spread of tumors and is associated with metabolic changes that can cause muscle loss, fatigue, anorexia and anxiety.
“In addition to advanced colorectal cancer, we have seen evidence of activity in other cancer tumor types and firmly believe that anti-IL-1-alpha therapy could be relevant in a broad range of malignancies,” Simard said.
The first quarter also saw important developments in the company’s infectious disease program. “We completed a Phase I dose-escalation study of our rapidly advancing antibody 514G3, which targets serious, often life-threatening forms of staphylococcus aureus bacteremia infections, including methicillin resistant strains (MRSA),” Simard said, “and we rapidly moved to enrolling patients in the Phase II portion of the study.” In this trial, patients are being randomized to receive either the highest dose of 514G3, as determined by the Phase I study, plus standard-of-care antibiotics, or placebo plus antibiotics. The Phase II study will measure efficacy in terms of time to clearance of bacteremia as measured by blood culture, duration of fever, length of hospitalization and incidence of mortality.
“We are excited about moving this program forward as quickly as possible to address the urgent need for safe and effective therapies for clearing these dreadful, life-threatening infections,” Simard said.
In anticipation of the approval and commercialization of Xilonix,
As part of its overall growth strategy,
SIGNIFICANT UPCOMING MILESTONES
- Results of the accelerated Assessment of Marketing Authorization Application for Xilonix™ in
- Pivotal Xilonix Phase III data presented at the 18th European Society of Medical Oncology’s
World Congress on Gastrointestinal Cancer, July 2016
- Pre-clinical data release for Staphylococcus aureus antibody 514G3 at the
Americas Antibody Congress, May 2016
- Complete 514G3 Phase II study
- Opening of new
Austinmanufacturing facility, 3Q16
Financial results for the quarter can be found in the investor section of XBiotech’s website (www.xbiotech.com).
Conference Call Information:
Interested participants and investors may access the conference call by dialing:
- 1 (844) 249-9385 (U.S.)
- 1 (270) 823-1533 (international)
- Conference ID: 7241703
A webcast will also be accessible via the Investors Relations section of the
About True Human™ Therapeutic Antibodies
Unlike previous generations of antibody therapies, XBiotech’s True Human™ antibodies are 100 percent human, derived from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.
The first of these therapies, Xilonix™, for advanced colorectal cancer, is in Phase III clinical trials in
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This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our
Media liaison U.S. Mariann Caprino 917.242.1087 Media liaison ex-U.S. Jonathan Kearney +44 20 8618 2755; Mobile: +44 7725 925 841