NASDAQ OMX

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 OMX

NASDAQ OMX
NASDAQ OMX
One Liberty Plaza - 165 Broadway
NY 10006 New York

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

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

Følg saker fra NASDAQ OMX

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

Siste saker fra NASDAQ OMX

Kofax Wins "Most Innovative Solution for Banking Customer Authentication" Award for Third Consecutive Year18.10.2017 08:00Pressemelding

Grand Prix Banque & Innovation Honor Recognizes Kofax Mobile ID Customer Onboarding Solution and its Anti-Fraud Capabilities IRVINE, Calif., Oct. 18, 2017 (GLOBE NEWSWIRE) -- Kofax ®, a leading provider of software to simplify and transform the First Mile(TM) of business, today announced that Kofax Mobile ID(TM) has won "Most Innovative Solution for Banking Customer Authentication" in the 2017 Grand Prix Banque & Innovation Awards in Paris, France. Now in its fourth year, the Awards identify excellence and innovation in the banking sector. The program acknowledges technology companies that have launched and implemented the most outstanding banking-related software solutions, initiatives and projects in France over the past twelve months. This award highlights the new facial recognition and ID verificationfeatures of Kofax Mobile ID that determine the authenticity and validity of identification documents and their holders.  

World Conference on Lung Cancer Wednesday Press Conference: PD-1/PD-L1 Advancements and Interventions to Prevent and Treat Lung Cancer18.10.2017 06:25Pressemelding

YOKOHAMA, Japan, Oct. 18, 2017 (GLOBE NEWSWIRE) -- The final press conference from the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) highlighted new advancements surrounding the discovery of PD-1 and PD-L1, including a discussion from the researcher credited with discovering PD-1, as well as interventions to prevent lung cancer and improve quality of life for lung cancer patients. Innovations in lung cancer treatment linked to the discovery of PD-1 Prof. Tasuku Honjo of Japan, who was the first to identify PD-1 in 1992, shared an update on how PD-1 blockers have been widely used to treat many types of cancers. After decades of study, research into PD-1 has led to breakthrough immunotherapy treatments that are being hailed as a "penicillin moment" in cancer treatment. "I believe that, just as a number of antibiotics developed in the wake of the discovery of penicillin now p

Barings Supports New Mountain Capital Investment in DRB Systems17.10.2017 16:30Pressemelding

CHARLOTTE, N.C., Oct. 17, 2017 (GLOBE NEWSWIRE) -- Barings, one of the world's leading asset management firms, announced today that it served as a Joint Lead Arranger on a Senior Secured Credit Facility to support New Mountain Capital's acquisition of DRB Systems LLC.                                                               Founded in 1984 and based in Akron, Ohio, DRB Systems is the leading provider of turnkey technology solutions used to enhance the operational efficiency of car wash sites across the U.S.  DRB's integrated technology offering includes hardware and software used in point-of-sale and tunnel control systems as well as ancillary modules to support marketing, human resources, and business analytics. "New Mountain Capital is pleased to have completed its investment in DRB Systems," said Jack Qian, Director of New Mountain Capital. Laura Holson, Head of Capital Markets at New Mountain added, "We deeply value Barings' support as a financing pa

Crown Bioscience to Showcase Scientific Expertise in Preclinical Evaluation of Investigational Cancer Compounds17.10.2017 16:12Pressemelding

SANTA CLARA, Calif., Oct. 17, 2017 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE:ticker 6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, will showcase their scientific expertise at this year's American Association for Cancer Research's International Conference on Molecular Targets and Cancer Therapeutics (AACR-NCI-EORTC) October 26th through the 30th. CrownBio's scientists will present 13 scientific posters describing their latest research efforts, including generation of novel models for combinatory chemotherapy and immunotherapy studies, creation of 3D screening panels for improved efficacy assessments, demonstration of a checkpoint immunotherapy modulating intestinal microbiota, among other innovative developments in cancer therapeutics and preclinical pharmacology evaluation. On

Oxford Immunotec Schedules Third Quarter 2017 Earnings Release and Conference Call for October 31, 201717.10.2017 15:15Pressemelding

OXFORD, United Kingdom and MARLBOROUGH, Mass., Oct. 17, 2017 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq:OXFD), a global, high-growth diagnostics company focused on developing and commercializing proprietary tests for the management of underserved immune-regulated conditions, today announced that it plans to release third quarter 2017 financial results prior to market open on Tuesday, October 31, 2017.  Dr. Peter Wrighton-Smith, Chief Executive Officer, and Rick Altieri, Chief Financial Officer, will host a conference call to review the Company's results at 8:00 a.m. Eastern Time the same day. The call will be concurrently webcast. To listen to the conference call on your telephone, please dial (855) 363-5047 for United States callers and +1 (484) 365-2897 for international callers and reference confirmation code 99539511, approximately ten minutes prior to start time.  To access the live audio webcast or subsequent archived recording, visit the Investor Relations se

World Conference on Lung Cancer Tuesday Press Conference: Evidence to Support Innovative Lung Cancer Interventions17.10.2017 08:16Pressemelding

YOKOHAMA, Japan, Oct. 17, 2017 (GLOBE NEWSWIRE) -- Today's press conference at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) featured groundbreaking findings in the study of both small cell and non-small cell lung cancer. The studies presented covered broad research areas, from confirmation of existing classification criteria to ensuring viability of evidence to supporting the use of specific interventions. Biopsy specimen found to be reliable for evaluating DLL3 expression in small cell lung cancer Small cell lung cancer (SCLC) biopsy specimen was found to be reliable material for evaluating DLL3 expression; high levels of DLL3 in SCLC are correlated with poor survival trends. These results may lead to further evaluation of the scoring system for predicting DLL3-targeted therapeutic efficacy and clinical significance of DLL3 expression in high-grade pulmonary neuroendocrine carcinomas.

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

Besøk vårt presserom