XBiotech Provides Update on Xilonix™ Phase III Programs in US and EU
23.7.2016 00:45 | NASDAQ OMX
AUSTIN, Texas, 2016-07-23 00:45 CEST (GLOBE NEWSWIRE) --
XBiotech Inc. (NASDAQ:XBIT), developer of next-generation True Human™ antibody therapies, said today that the Independent Data Monitoring Committee (DMC) for the XCITE Phase III clinical study of Xilonix™ for the treatment of colorectal cancer, recently recommended study continuation without any amendment to the study design. The DMC convened as scheduled, subsequent to the enrollment of 400 patients into the study.
The DMC mandate is to “monitor for early evidence of treatment harm and to routinely recommend to continue, suspend, or otherwise modify enrollment based on their findings.” The DMC did not have any recommendations for the Company regarding any need for changes to the study operation. This is viewed as a positive assessment with respect to safety, as well as to key aspects of study execution. Another DMC meeting is scheduled to occur either after 600 patients have been enrolled, or potentially earlier if the study meets its first planned efficacy analysis milestone. Xilonix has been granted FDA fast-track review and the XCITE study is on schedule to reach its enrollment milestones in 2016.
The Company’s marketing authorization application for Xilonix for the treatment of colorectal cancer remains on schedule to achieve a decision in 2016 by the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP). The Company recently scheduled an in-person meeting with the CHMP. The Company believes the meeting will help advance the marketing authorization process and has agreed with the CHMP for the MAA to be reviewed under the standard assessment timetable, rather than the accelerated review timeline that was granted in April 2016. The Company says that the standard timetable will provide additional time to conduct the MAA process. The standard timetable is expected to add approximately 60-days to the review proceedings.
About Xilonix™ and Interleukin-1 alpha (IL-1α)
Xilonix™ is the first monoclonal antibody to specifically target and neutralize interleukin-1 alpha (IL-1α), one of the most potent inflammatory signaling molecules. The IL-1 pathway in general, and IL-1α in particular, is a desirable target for anti-cancer therapy because of its potential role in both local and systemic effects of cancer.i,ii IL-1α in the tumor microenvironment is known to promote angiogenesis (the growth and spread of tumors), as well as mediate symptoms such as metabolic dysregulation (e.g., loss of weight and muscle mass), fatigue and anxiety associated with advanced cancer.
About True Human™ Therapeutic Antibodies
Unlike previous generations of antibody therapies, 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.
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.
i Apte RN, Voronov E. Interleukin-1 a major pleiotropic cyto-kine in tumor-host interactions. Can Biol. 2002;12:277–290.
ii Dinarello CA. Interleukin-1α neutralisation in patients with cancer. Lancet Oncol. 2014;15(6):552-553.
+44 20 8618 2755
Om NASDAQ OMX
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
PayByPhone Appoints Francis Dupuis as new CEO24.8.2017 01:14 | Pressemelding
VANCOUVER, British Columbia, Aug. 23, 2017 (GLOBE NEWSWIRE) -- PayByPhone, the global leader in mobile parking payments, today announced that it has appointed Francis Dupuis as President and Chief Executive Officer effective August 23rd, 2017. Kush Parikh, former President and CEO, has stepped down from the role after his successful 3.5-year term with the business. During his time at PayByPhone, Kush led the business to profitability, established a strong focus on end customers and was pivotal in its ground-breaking sale to Volkswagen Financial Services. "With more than 20 years of experience in the software industry and a deep product background, Francis is exactly the kind of leader we need to further grow and innovate in the parking market on an international scale," said Stefan Imme, Head of M&A and Investment Management at Volkswagen Financial Services AG. Francis, a long-standing member of the executive team at PayByPhone, takes the reins at a
EPAM Hosts Scratch Conference in Budapest to Bring Together IT Educators Around the World23.8.2017 16:00 | Pressemelding
NEWTOWN, Pa., Aug. 23, 2017 (GLOBE NEWSWIRE) -- EPAM Systems, Inc. (NYSE:EPAM), a leading global provider of digital platform engineering and software development services, will host the Scratch Conference in Budapest, Hungary from August 24-25, 2017. The event is one of six conferences held globally to bring together hundreds of Scratch educators and IT experts. Developed by MIT, Scratch is a foundational tool and coding platform used primarily by children to learn the basics of programming. During this free event, attendees will hear from over 60 experts and explore all facets of computing, including best practices in using Scratch and additional tools that integrate with the platform. Several renowned speakers will attend the conference including Mitchel Resnick, Professor of Learning Research at the MIT Media Lab and Chair of the Scratch Foundation; Ariam Mogos, Learning Lead, Office of Innovation at UNICEF; and Genevieve Smith-Nunes, Entrepreneur and a Lecturer at Roeha
Novavax' Preclinical Influenza Nanoparticle Study Published in Vaccine23.8.2017 13:00 | Pressemelding
Novel vaccine candidate, NanoFlu(TM), outperforms market-leading Fluzone® High Dose based on antibody titers and neutralization of recent and historic influenza viruses in a preclinical study GAITHERSBURG, Md., Aug. 23, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) today announced that data from a preclinical study of its nanoparticle influenza vaccine candidate with its proprietary Matrix-M(TM) adjuvant (NanoFlu(TM)) have been published in the journal Vaccine. Novavax is developing NanoFlu to protect older adults from seasonal influenza. The manuscript describes the formulation of Novavax' novel seasonal influenza vaccine candidate, NanoFlu, based on the 2017-2018 World Health Organization (WHO) recommended influenza strains. The study, conducted in ferrets, found that NanoFlu induced hemagglutination-inhibition (HAI) and microneutralizing (MN) antibodies against a broad range of influenza subtypes. In a head-to-head comparison against standard-dose and high-do
Crown Bioscience Names Dr. Leon Hall Vice President of Global Scientific Excellence23.8.2017 12:29 | Pressemelding
SANTA CLARA, Calif., Aug. 22, 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, announced today the appointment of Dr. Leon Hall as Vice President of Global Scientific Excellence. In his new role, Dr. Hall will be responsible for overseeing global R&D programs and advancing Crown Bioscience's scientific excellence initiatives. "Leon's appointment reinforces Crown Bioscience's dedication to innovation and commitment to providing the highest quality therapeutic technology services," said Jean-Pierre Wery, Ph.D., Crown Bioscience Chief Executive Officer. "His extensive scientific and operational experience will serve Crown Bioscience well as we expand to meet the growing needs of preclinical research to the global
Blackbird Energy Inc. annonserer utnevnelsen av Allan Dixon som sjef for bedriftsutvikling23.8.2017 12:02 | Pressemelding
CALGARY, Alberta, 23. aug. 2017 (GLOBE NEWSWIRE) - Blackbird Energy Inc. (TSX-V:BBI) («Blackbird») har gleden av å kunngjøre utnevnelsen av Allan Dixon som sjef for bedriftsutvikling. I denne rollen vil Dixon være ansvarlig for investorrelasjoner, kommunikasjonsinitiativer og strategiske bedriftsbevissthetsprogrammer i Nord-Amerika og Europa. Dixon har en omfattende bakgrunn i Calgarys olje- og gassindustri med erfaring fra investorrelasjoner ved Birchcliff Energy Ltd., aksjeanalyse ved National Bank Financial og investeringsrelatert bankvirksomhet ved Tristone Capital. Dixon har en bachelorgrad i handelsfag med spesialisering innen finans fra Dalhousie University. «Jeg er veldig glad for å ønske Allan velkommen til Blackbird-teamet, og jeg ser frem til å jobbe med ham. Med sin varierte bakgrunn og erfaring med å jobbe med noen av verdens fremste innovatører i bransjen, har jeg den største tillit til at han vil være et verdifullt tilskudd til teamet vårt og en ressurs fo
International Body Positive Mentor, Arabella S. Ruby, Launches New Fashion Collection Under the Xehar Brand, Arabella by Xehar23.8.2017 12:00 | Pressemelding
Xehar's successful ambassador marketing campaign continues to drive online sales while spreading body positive messages among millennials around the world PLAYA VISTA, Calif., Aug. 23, 2017 (GLOBE NEWSWIRE) -- Today Xehar launches their newest collection Arabella by Xehar, an edgy and contemporary plus size fashion line targeting progressive millennials. High demand for Xehar's custom clothing lines can be seen by the recent collection Laura by Xehar, which sold out in a record 10 days. Xehar has developed a proven method in creating collections inspired by Body Positive Mentors who have a significant social media following. A photo is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/10d6e5d8-c740-4c41-aa56-2255e6f70ad9 "Customers appreciate authenticity, and we are seeing great results by sharing our products through our Body Positive Mentors," says Hadari Oshri, CEO and founder of Xehar. "We are actively searching for m
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom