XBiotech Provides First Quarter 2016 Corporate and Clinical Update
(Thomson Reuters ONE) -
Conference Call and Webcast today, May 18 at 8:30 a.m. ET
RECENT HIGHLIGHTS
* 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 18(th) European Society of Medical
Oncology's World Congress on Gastrointestinal Cancer on July 1 in Barcelona,
Spain.
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.
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 companies."
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.
SIGNIFICANT UPCOMING MILESTONES
* 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 (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
XBiotech website www.investors.xbiotech.com. 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 www.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.
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
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: XBiotech, Inc via GlobeNewswire
[HUG#2013618]
Datum: 18.05.2016 - 14:03 Uhr
Sprache: Deutsch
News-ID 472033
Anzahl Zeichen: 10869
contact information:
Town:
Austin
Kategorie:
Business News
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