XBiotech to Present Pivotal Phase 3 Data on Xilonix™ at European Society of Medical Oncology’s World Congress on Gastrointestinal Cancer
- First Time Pivotal Phase 3 Xilonix™ Data To Be Unveiled at Major Scientific Congress
- Developed Specifically to Treat Advanced Cancer, Xilonix™ is First Antibody Therapy to Neutralize Biological Activity of Interleukin-1α (IL-1a)
- Xilonix™ Recently Granted Accelerated Review for Marketing Authorization by the European Medicines Agency (EMA); a decision on Xilonix™ approval could come as early as fourth quarter 2016
AUSTIN, Texas, April 19, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT), developer of next generation True Human™ antibody therapies, today announced it will present pivotal Phase 3 data for Xilonix™, the Company’s lead therapy developed for the treatment of advanced colorectal cancer, at the 18th ESMO World Congress on Gastrointestinal Cancer. This will be the first presentation of the Phase 3 data at a major scientific congress. The 18th ESMO World Congress on Gastrointestinal Cancer, considered the premier scientific event for gastrointestinal cancer, will be held June 29 to July 2 in Barcelona, Spain.
A potential breakthrough for patients with advanced colorectal cancer, Xilonix™ is specifically designed to target and neutralize interleukin-1 alpha (IL-1a), a molecule known to promote angiogenesis (the growth and spread of tumors), as well as mediate symptoms such as metabolic dysregulation (e.g., a cause of muscle loss and weight loss), fatigue and anxiety associated with advanced cancer.
The abstract, entitled “A Pivotal Phase 3 Trial of Xilonix™ in Advanced Colorectal Cancer,” will be presented by Dr. Tamas Hickish, Chair of the Xilonix™ European Phase 3 Study, and Consultant Medical Oncologist, Royal Bournemouth Hospital NHS Foundation Trust, UK. Colorectal cancer is the leading cause of malignancy in the industrialized world.
About True Human™ Therapeutic Antibodies
XBiotech is pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. Unlike previous generations of antibody therapies, XBiotech’s True Human™ 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™, for advanced colorectal cancer is in Phase 3 clinical trials in the United States with a Fast Track designation by the U.S. Food and Drug Administration (FDA). In Europe, Xilonix™ Phase 3 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).
XBiotech is a fully integrated global 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 improve the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech is expanding its state-of-the-art manufacturing with launch of a new commercial-scale facility in 2016. The manufacturing process has been designed to dramatically reduce time and cost while increasing flexibility, representing a new approach to biotech manufacturing. For more information, visitwww.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.
Media liaison ex-U.S.
+44 20 8618 2755; Mobile: +44 7725 925 841
Om 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
Airtel and Cisco Team to Improve Mobile User Experience25.2.2018 12:00 | Pressemelding
Utilizing Cisco's Self-Optimizing Network solutions to manage and support the massive growth in data and voice traffic BARCELONA, Spain, Feb. 25, 2018 (GLOBE NEWSWIRE) -- Mobile World Congress - With mobile data consumption surpassing usage of the U.S. and China in 20171, mobile service providers in India are working to enhance their network infrastructure to manage and support the growth surge and ensure quality of customer experience. Bharti Airtel (Airtel), India's largest telecommunications services provider, and Cisco have joined forces to improve customer experience by taking their SON collaboration to next level. SON is now carrying out optimization based on customer experience and predictive analytics apart from the traditional approach of responding to network degradations. SON self-healing applications have been enriched for taking proactive actions in near real time, using predictive machine learning and interworking of SON with NOC tools, PM analytics & customer experience
Cisco Spearheads Multi-Vendor Open vRAN Ecosystem Initiative For Mobile Networks25.2.2018 12:00 | Pressemelding
First ecosystem of its kind brings together innovators including Reliance Jio, Altiostar, Aricent, Intel, Mavenir, Phazr, Red Hat, and Tech Mahindra BARCELONA, Spain, Feb. 25, 2018 (GLOBE NEWSWIRE) -- Mobile World Congress - Mobile network operators are facing strong pressures to evolve their businesses and operations for profitable growth and differentiation. Explosive demand for bandwidth persists, while ARPU pressures mount due to competition and limited service innovation. Addressing these challenges requires industry innovation focused on delivering new revenue-generating services based on a more flexible and agile service delivery environment, while reducing Capex and Opex. Innovations such as network function virtualization have laid the groundwork for a new fundamental architecture to emerge. While many functions of a mobile network are being virtualized, including the Evolved Packet Core (EPC), IP Multimedia Subsystems (IMS), the Gateway Internet LAN (Gi-LAN) and data transpor
TIM and Cisco Join Forces To Increase The IT Security Of Italian Companies25.2.2018 12:00 | Pressemelding
TIM Safe Web, the new security service developed in collaboration with Cisco and integrated into the TIM network, going live in March BARCELONA, Spain, Feb. 25, 2018 (GLOBE NEWSWIRE) -- Mobile World Congress - Starting from March, TIM, the leading provider of mobile and fixed telecommunication services in Italy, in partnership with Cisco will offer "TIM Safe WEB", a highly secure platform service, integrated in the TIM network, able to safeguard small business users from malware, such as ramsomware, phishing, and other malicious cybersecurity activities. TIM Safe Web combines TIM's unique technologies and information with the capabilities of the Cisco Umbrella cloud-based security platform, which leverages a constantly updated global database of threat intelligence. This "over-the-network" service enhancement will be provided to about 600.000 TIM Business customers in order to improve both security and quality of service starting from small business market that is very exposed to cyber
Cisco Launches New '5G Now' Portfolio for Service Providers Taking Action Today25.2.2018 12:00 | Pressemelding
More than 20 global service provider and mobile operator customers worldwide are advancing their 5G action plans with Cisco BARCELONA, Spain, Feb. 25, 2018 (GLOBE NEWSWIRE) -- Mobile World Congress - Continuing on its path to disrupt the industry by redefining the network, Cisco announced today its '5G Now' portfolio for service providers ready to go full throttle on their 5G roadmap. 5G services promise to offer emerging new services at significantly faster speeds, expanded capacity and stronger coverage to accommodate the more than 27 billion connected devices1 expected on service provider networks by 2021. Beginning 2020, 5G connections will grow more than a thousand percent from 2.3 million in 2020 to over 25 million in 20212. At Mobile World Congress this week, many technology vendors are focused on the spectrum advantages, radio equipment and architecture to support 5G services. Cisco is committed to showing service providers and mobile operators why 5G is important to plan for,
Cisco and TIM: Together to Accelerate Italy's Digitization25.2.2018 12:00 | Pressemelding
BARCELONA, Spain, Feb. 25, 2018 (GLOBE NEWSWIRE) -- Mobile World Congress - Cisco and TIM, the leading service provider in Italy, announced a major agreement aimed at accelerating Italy's digitization today at Mobile World Congress. The two companies are engaged in developing a joint business and innovation program. They will leverage their unique competences and technologies, to create next generation solutions and services focused in particular on Cybersecurity, Internet of Things, Industry 4.0, Smart Cities and 5G. This Memorandum of Understanding (MOU) has been signed in the framework of Digitaliani, the three-year investment plan launched by Cisco in January 2016, whose objectives are well aligned with TIM own digitization program. The partnership is based on three pillars. Sharing competences and solutions for the digital transformation of companies, public sector and services targeted to citizens A common effort to develop a partner ecosystem able to leverage the new opportuniti
Valero to Purchase SemLogistics Milford Haven Fuel Storage Facility23.2.2018 22:15 | Pressemelding
LONDON, Feb. 23, 2018 (GLOBE NEWSWIRE) -- Valero Logistics UK Ltd, a subsidiary of Valero Energy Corporation (NYSE:VLO), and SemGroup Europe Holding L.L.C., a SemGroup Corporation company, have today signed an agreement for the purchase of SemLogistics Milford Haven fuel storage facility on the west coast of Wales. Situated across the Haven from Valero's refinery at Pembroke, the facility is one of the largest petroleum products storage facility in the United Kingdom (UK) with 8.5 million barrels of capacity for storing gasoline, gasoline blendstocks, naphtha, jet fuel, gas oil, diesel, and crude oil. Over 67 percent of the storage capacity is multiproduct or dual purpose, giving Valero the flexibility to meet customers' demands in the UK and throughout Northwest Europe. Additionally, Milford Haven will continue to operate as a third-party storage facility, offering storage options for third party customers across the European petroleum markets. "This facility complements our Pembroke
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom