Nasdaq GlobeNewswire

XBiotech Completes Dosing of Subjects in PK Study Being Conducted in Connection with European Marketing Application

Del

AUSTIN, Texas, 2017-02-22 14:00 CET (GLOBE NEWSWIRE) --

XBiotech Inc. (NASDAQ:XBIT) announced that all subjects have been dosed in its pharmacokinetic (PK) study evaluating MABp1 half-life in healthy volunteers. This Phase I study will provide further PK data and will enable additional characterization of the PK of MABp1 at a 7.5mg/kg IV dose. Safety and tolerability will also be assessed. PK analyses at various time points ranging from pre-infusion to 336 hours post infusion will be collected. The study is on schedule to be completed as planned for the Company’s upcoming regulatory submission.

The Company previously reported it had been granted an additional 30 days to submit its responses to the Day 180 List of Outstanding Issues (D180LOI) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in connection with the Company’s Marketing Authorization Application for Xilonix. This extension was granted as a result of a clarification meeting held recently between XBiotech and the EMA. The extension was granted in order to allow sufficient time for the Company to complete the PK study in healthy subjects. These new PK data are intended to address relevant technical questions in the D180LOI and will be included in the Company’s response submission scheduled for March 22nd.

“We are happy to report the expeditious execution of this study, which will provide further PK data at multiple time points in the first 96 hours after dosing. This will enable additional and accurate characterization of the peak concentration, half-life and clearance, thus confirming PK is consistent with what would be expected from a monoclonal antibody,” commented Michael Stecher, XBiotech’s Medical Director. He further stated, “With these additional data in hand, we look forward to fully addressing the complete list of day 180 questions in March.”

About True Human™ Therapeutic Antibodies
XBiotech’s True Human™ 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™ 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.

         Contact
         Ashley Otero
         aotero@xbiotech.com
         512-386-2930

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

Oxford Immunotec and QIAGEN N.V. Settle Patent Infringement Lawsuit15.12.2017 22:04Pressemelding

Agreement includes payment of $27.5 million to Oxford, royalty-free license to QIAGEN and dismissal of all pending litigation OXFORD, United Kingdom and MARLBOROUGH, Mass., Dec. 15, 2017 (GLOBE NEWSWIRE) -- Oxford Immunotec Ltd. (Nasdaq:OXFD) and QIAGEN N.V. (Nasdaq:QGEN) (Frankfurt Stock Exchange:QIA) announced today that they have reached a settlement in the lawsuit in the U.S. District Court for the District of Massachusetts in Boston (15-cv-13124-NMG) alleging patent infringement in relation to QIAGEN's QuantiFERON®-TB Gold and QuantiFERON®-TB Gold Plus products. Under terms of the agreement, all pending claims between Oxford and QIAGEN and the co-defendants have been resolved. As part of the settlement, Oxford has granted QIAGEN a royalty-free, non-exclusive license that extends to all current and future customers of QuantiFERON-TB Gold and QuantiFERON-TB Gold Plus in exchange for a one-time, lump-sum payment of $27.5 million.  The settlement includes general

Algeco Scotsman Announces Acquisition of Iron Horse Ranch15.12.2017 21:32Pressemelding

BALTIMORE, Dec. 15, 2017 (GLOBE NEWSWIRE) -- Algeco/Scotsman Holding S.à r.l. (together with its subsidiaries, the "Algeco Group") today announced the successful closing of the acquisition by the Algeco Group's subsidiary, Target Logistics Management, LLC ("Target Logistics"), of Iron Horse Ranch from funds managed by TDR Capital LLP ("TDR"). The acquisition solidifies Target Logistics' position as the single largest provider of turnkey workforce housing in the U.S., including a network of eight lodges and 2,119 beds in the Permian Basin. With the acquisition, Target Logistics' Permian Basin lodge network now includes Texas lodges in Pecos, Mentone, San Angelo and two in Odessa, along with two lodges in Carlsbad and Lovington, New Mexico. Additionally, Target Logistics adds Eagle Ford lodges in Cameron and Yorktown, Texas. Diarmuid Cummins, CEO Algeco Scotsman: "Today we announce the completion of the second of two strategic acquisitions which we flagged earlier

Elemica Named to Food Logistics Top 100 List15.12.2017 13:55Pressemelding

11th Consecutive Win for Delivering Value Across Clients' Supply Chains WAYNE, Pa., Dec. 15, 2017 (GLOBE NEWSWIRE) -- Elemica, the leading  Business Network for the process industries, announces the company has been named to Food Logistics magazine's FL100+ Award for the 11th year. The FL100+ list recognizes leading software and technology providers in the food and beverage industry.  Elemica was chosen for helping agricultural and food ingredient businesses conduct more efficient and error free commerce across their community of suppliers, customers and logistics providers - delivering value through lower operating expenses and working capital costs. "We are honored to be included for the past eleven years on the Food Logistics FL100+ list for helping companies improve efficiencies and generate value from their supply chains," said John Blyzinskyj, CEO of Elemica. "Automating business processes, enabling end-to-end visibility, and providing a platform for

GSV Asset Management Announces Strategic Investment from HMC Capital-Led Group14.12.2017 21:03Pressemelding

WOODSIDE, Calif. and NEW YORK, Dec. 14, 2017 (GLOBE NEWSWIRE) -- GSV Asset Management, LLC ("GSV"), a modern merchant bank that identifies, advises, and invests in the fastest growing, most dynamic companies in the world - the Stars of Tomorrow - today announced a strategic investment from a group led by HMC Capital ("HMC"), a leading Latin American advisory and investment firm. While terms of the deal were not disclosed, the investment will result in a minority ownership interest for the HMC-led group in GSV Asset Management. Proceeds will be used to enhance GSV's ongoing investment activities, as well as to accelerate its strategic expansion into new business areas and geographies. "We are very excited to partner with HMC Capital, a multi-billion dollar asset manager that brings a range of complimentary capabilities to GSV Asset Management," said Michael Moe, founder of GSV. "GSV stands for Global Silicon Valley and our alliance with HMC reflects our shared commitment t

TrueCommerce Datalliance Releases Third 2017 Update for Vendor Managed Inventory Platform14.12.2017 19:28Pressemelding

Latest Software Update Enhances Browser, Productivity Experience CINCINNATI, Dec. 14, 2017 (GLOBE NEWSWIRE) -- TrueCommerce Datalliance, a leading vendor managed inventory service solutions provider, announced today that it released the third scheduled 2017 update to its VMI platform. The free update is part of TrueCommerce Datalliance's commitment to improving the functionality of its cloud-based supply chain software. Highlights of the release include several improvements to its system architecture and capabilities: Google Chrome is now officially supported Order Worksheets are now easier to view in Internet Explorer One-click access to recently changed or added items Mass Launch Order Preview lists all items suggested or added via allocation "We promise our customers three major updates every year," said Connie Shafer, TrueCommerce Datalliance Producti

ATTO announces support for Apple® Release of the new iMac Pro14.12.2017 18:37Pressemelding

ATTO's line of ThunderboltTM technology enabled products continue to revolutionize connectivity to storage AMHERST, N.Y., Dec. 14, 2017 (GLOBE NEWSWIRE) -- ATTO Technology, Inc., a global leader of storage and network connectivity and infrastructure solutions for data-intensive computing environments, today confirmed their continued commitment to the newly released line of product updates and innovations from Apple. With the powerful and new iMac Pro® now shipping, ATTO continues to support the new offerings from this industry leading manufacturer. "Our deep relationship with Apple over the last 30 years continues to drive our position as a leading force within the Apple community," said Timothy J. Klein, president and CEO at ATTO Technology. The iMac Pro sets a new standard for Apple design and performance and complements why users select ATTO products. As Apple pushes the boundaries of desktop computing, ATTO continues to provide industry leading products that op

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom