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XBiotech, Inc: XBiotech Provides First Quarter 2016 Corporate and Clinical Update

Conference Call and Webcast today, May 18 at 8:30 a.m. ET


* European Medicines Agency accepts Marketing Authorization Application for
Xilonix(TM) 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

AUSTIN, Texas, May 18, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT),
developer of next-generation True Human(TM) therapeutic antibodies, today
provided a business update for the first quarter ended March 31, 2016.
Company Founder and Chief Executive Officer John Simard, along with
XBiotech's senior leadership and management team, reviewed first-quarter
clinical developments and provided updates on the company's pipeline,
research and development operations and new manufacturing facility during
this morning's conference call and audio webcast at 8:30 a.m. ET.

Simard said XBiotech made significant progress during the quarter, including
advancing its lead candidate Xilonix(TM), a True Human therapeutic antibody
in development for the treatment of advanced colorectal cancer, toward
regulatory approval. "Just a month after submitting our Marketing
Authorization Application to the European Medicines Agency, the Agency
granted Xilonix accelerated review," Simard said. "We are rapidly advancing
this remarkable candidate therapy through clinical trials and now are poised
for our first drug approval, which could come as early as the fourth quarter
of 2016." Xilonix also has received Fast Track designation from the U.S. Food
and Drug Administration (FDA).

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 World Congress on Gastrointestinal Cancer on July 1 in Barcelona,

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

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.

XBiotech continues to develop its pipeline of True Human antibody therapies.
"We have initiated 10 clinical programs across a range of diseases and
medical conditions. We continue to see that our ability to rapidly and
cost-effectively transition from discovery to potential breakthrough
therapies is unprecedented," Simard said. "In breadth and depth, XBiotech's
pipeline rivals those of far larger and longer-established pharmaceutical

In anticipation of the approval and commercialization of Xilonix, XBiotech is
enhancing its manufacturing capacity and quality programs. "We are looking
forward to the completion of the new facility that will house our expanded
manufacturing operations on our Austin campus," Simard said. The company
plans to move in during the third quarter of 2016.

As part of its overall growth strategy, XBiotech continues to build the senior
leadership team. Amgen veteran Scott Whitehurst was appointed Chief Financial
Officer and will oversee the Company's financial operations, capital
requirements and investor relations function. In addition, former head of
medical research at Biogen Inc. Dawn McCollough was named Vice President of
Clinical Operations, bringing to XBiotech more than two decades of oversight
in all phases of drug development.


* Results of the accelerated Assessment of Marketing Authorization
Application for Xilonix(TM) in Europe, 3Q16
* Pivotal Xilonix Phase III data presented at the 18 th 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 Austin manufacturing facility, 3Q16

Financial results for the quarter can be found in the investor section of
XBiotech's website (

Conference Call Information:

Interested participants and investors may access the conference call by

* 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
XBiotech website The webcast replay will remain
available for 90 days.

About True Human(TM) Therapeutic Antibodies

Unlike previous generations of antibody therapies, XBiotech's True Human(TM)
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(TM), 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).

About XBiotech

XBiotech is a fully integrated global biosciences company dedicated to
pioneering the discovery, development and commercialization of therapeutic
antibodies based on its True Human(TM) 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, visit

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.

Media liaison U.S.
Mariann Caprino

Media liaison ex-U.S.
Jonathan Kearney
+44 20 8618 2755; Mobile: +44 7725 925 841


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: XBiotech, Inc via Globenewswire


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