XBiotech Completes Enrollment in Global Phase I/II Study for its True Human(TM) Antibody Treatment for Serious Staphylococcus aureus Infections
(Thomson Reuters ONE) -
Study for 514G3 Antibody has Fast Track Designation by the FDA
AUSTIN, Texas, Dec. 06, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT),
developer of True Human(TM) therapeutic antibodies, today announced that
enrollment has been completed in its randomized, placebo-controlled Phase I/II
study evaluating dosing, safety and efficacy of the Company's novel antibody
therapy, 514G3. This proprietary antibody therapy has received Fast Track
Designation by the FDA for the treatment of all forms of Staphylococcus
aureus infections, including Methicillin-resistant S. aureus (MRSA). The Company
reports that top-line findings from the 514G3 study should be reported in first
quarter 2017.
"We are pleased to announce enrollment completion in this study," said Dawn
McCollough, Vice President of Clinical Operations at XBiotech. "We are dedicated
to developing this novel therapy to treat these life-threatening bacterial
infections, which affect millions of people world-wide. This is an important
milestone, bringing us one step closer to potentially addressing the urgent need
for a safe and effective S. aureustherapy. We look forward to presenting
findings from this study early next year."
Patients enrolled in the Phase II portion of the study were randomized to
receive the highest dose of 514G3, as determined by the Phase I portion of the
study, plus standard of care antibiotics vs. placebo plus antibiotics. Patients
were treated in hospital settings at sites in the United States, Germany, Taiwan
and Korea. In addition to safety and tolerability evaluation, the study includes
efficacy measures such as time to clearance of bacteremia (as measured by blood
culture), duration of fever, serious adverse events, length of hospitalization
and survival. The randomized, blinded Phase II portion has enrolled 36
patients, with 24 of those patients randomized to receive 514G3.
About 514G3
514G3 was developed from a healthy human donor with natural antibodies effective
at neutralizing MRSA and non-MRSA forms of S. aureus. 514G3 knocks out the
principle immune evasion mechanism of the bacteria, allowing white blood cells
to detect and destroy the bacteria. 514G3 has potential to treat all strains of
MRSA and can be used without consideration for strain-specific resistance to
various antibiotics. As a True Human monoclonal antibody, 514G3 is expected to
be well tolerated without the side effects or risks of antibiotics, including
the lack of risk of antibiotic resistance.
About Staphylococcus aureus
Staphylococcus aureus (S. aureus) is a leading cause of bacteremia and is
associated with higher morbidity compared with other pathogens. S.
aureus bloodstream infections are among the most common but also most difficult
to treat(1). The incidence of S. aureus, specifically bacteremia caused by
methicillin-resistant S. aureus (MRSA) strains, has dramatically increased in
recent years in the U.S. and parts of Europe(2)(,3). This is partly
attributable to increased resistance of S. aureus strains to available
antibiotics. The burden of MRSA bacteremia is high with substantial costs and
resources for healthcare systems(4). Therefore, there remains an urgent need for
new treatment approaches.
About True Human(TM) Therapeutic Antibodies
Unlike previous generations of antibody therapies, XBiotech's True Human(TM)
antibodies are derived without modification 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.
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 redefine 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.
(1) Wisplinghoff H, Bischoff T, Tallent SM, Seifert H, Wenzel RP, Edmond MB.
Nosocomial bloodstream infections in US hospitals: analysis of 24,179 cases from
a prospective nationwide surveillance study. Clin Infect Dis 2004; 39:309-17.
(2) Steinberg JP, Clark CC, Hackman BO. Nosocomial and community acquired
Staphylococcus aureus bacteremias from 1980 to 1993: impact of intravascular
devices and methicillin resistance. Clin Infect Dis 1996; 23:255-9.
(3) EARSS management team. European Antimicrobial Resistance Surveillance System
annual report 2006. Bilthoven, The Netherlands: National Institute for Public
Health and the Environment, 2007.
(4) Shorr AF, Lodise T. Burden of methicillin-resistant Staphylococcus aureus on
healthcare cost and resource utilization. ISMR Update 2006; 1:4-11.
Contact
Ashley Otero
aotero(at)xbiotech.com
512.386.2930
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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
Unternehmensinformation / Kurzprofil:
Datum: 06.12.2016 - 14:00 Uhr
Sprache: Deutsch
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