XBiotech Names Industry Veteran Dawn McCollough to Head Clinical Operations
AUSTIN, Texas, 2016-05-16 14:00 CEST (GLOBE NEWSWIRE) --
XBiotech (NASDAQ:XBIT), the developer of True Human™ therapeutic antibodies, today announced that Dawn McCollough has joined the company as Vice President of Clinical Operations, effective May 16. McCollough has more than two decades of global industry experience and has overseen all phases of clinical trial drug development across multiple therapeutic areas.
Reporting to XBiotech Founder, President and Chief Executive Officer John Simard, McCollough will lead clinical operations for XBiotech’s extensive portfolio of True Human antibody therapies, including Xilonix™, the Company’s lead candidate currently in late-stage development for the treatment of advanced colorectal cancer.
“Dawn has overseen clinical trials involving thousands of patients across multiple indications and stages of development,” Simard said. “She thus brings extraordinary experience to our clinical operations. I am delighted to bring her energy and enthusiasm to the XBiotech leadership team.”
McCollough joins XBiotech from Biogen, Inc., where she served as head of Medical Research Operations and led the Medical Research team, which included the company’s Clinical Trial Review Committee. Prior to Biogen, McCollough was head of the Global Monitoring Organization for North America at Novartis Vaccines and Diagnostics, Inc., based in Cambridge, Mass. McCollough began her Novartis career in their Vaccines and Diagnostics division in Siena, Italy, as Global Head of Clinical Trial Governance. She has been recognized consistently for her high performance and was chosen as a top Women’s Leader by both companies.
“I am excited to join XBiotech in advancing the Company’s innovative True Human therapeutic antibodies through the clinical process across multiple therapeutic areas. My focus will be on demonstrating our commitment to our investigators and patients in the continued development of potentially groundbreaking new medicines.”
XBiotech’s lead product candidate, Xilonix, has the potential to change the standard of care in treating advanced colorectal cancer. Currently in Phase III clinical trials in the U.S. with Fast Track designation from the U.S. Food and Drug Administration, Xilonix is specifically designed to target and neutralize interleukin-1 alpha (IL-1a), a molecule known to promote angiogenesis (the growth and spread of tumors), as well as mediate symptoms such as metabolic dysregulation (e.g., a cause of muscle loss and weight loss), fatigue and anxiety associated with advanced cancer.
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 the United States with a Fast Track designation by the U.S. Food and Drug Administration (FDA). In Europe, Xilonix Phase III clinical trials have been completed, and the therapy is under accelerated review following the validation of its Market Authorization Application by the European Medicines Agency (EMA).
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to exceed the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visitwww.xbiotech.com.
Cautionary Note on Forward-Looking Statements
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 SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
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