Gilead Terminates Phase 2/3 Study of GS-5745 in Patients With Ulcerative Colitis
21.9.2016 21:00 | Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company is stopping its combined Phase 2/3 clinical study of GS-5745, an investigational anti-MMP9 antibody, among patients with moderately to severely active ulcerative colitis. This decision follows a planned interim analysis of unblinded efficacy and safety data by the Data Monitoring Committee (DMC) after the first 150 patients of a planned 1600-patient trial were treated for an 8-week induction duration. The DMC recommended that the study be terminated early due to meeting the pre-specified futility and efficacy criteria. No safety concerns were noted in this interim analysis. Gilead has also reviewed the data and determined that there is insufficient evidence of a treatment benefit in the group of patients randomized to receive either one of two doses of GS-5745.
Separately, a Phase 3 study of GS-5745 is ongoing in patients with gastric cancer, as well as a Phase 2 study in patients with gastric cancer in combination with nivolumab and additional Phase 2 studies in moderately to severely active Crohn’s disease, rheumatoid arthritis and cystic fibrosis. These studies will continue as planned.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from other clinical trials for GS-5745. In addition, it is possible that Gilead may make a strategic decision to discontinue development of GS-5745 if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. As a result, GS-5745 may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.
Sung Lee, 650-524-7792
Nathan Kaiser, 650-522-1853
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Spirent Tests Wi-Fi Network Performance with O2 at the Coca-Cola London Eye17.8.2017 15:57 | Pressemelding
Spirent Communications plc (LSE:SPT), today announced its Landslide E10 network test platform has been used with O2 to validate the Wi-Fi network performance and capacity at the Coca-Cola London Eye, before the launch of a new smartphone application last month. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170817005758/en/ Spirent Landslide E10 helped O2 validate Wi-Fi performance and capacity at the Coca-Cola London Eye, before the launch of a new smartphone application last month. (Photo: Busines Wire) Merlin Entertainments plc, operator of the London Eye, wanted to measure its Wi-Fi network performance, to ensure its infrastructure could provide an excellent experience for users of the new app, which puts increased demands on the Wi-Fi network. “The London Eye is a global attractio
Watch BizWireTV: A Camera You Can Wear and Krispy Kreme’s Famous Donuts Get Eclipsed with Chocolate17.8.2017 12:08 | Pressemelding
On BizWireTV, catch some Quick Biz Hits and see the latest in Star Power. Also see what’s happening in the startup world with the Accelerator Report, featuring the VC Watch and this week’s Startup Standout. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170817005305/en/ BizWireTV is hosted by Jordyn Rolling (Photo: Business Wire Now you can watch BizWireTV, and the latest breakthroughs in tech from the biggest brands, on any screen you want by downloading the new app through the Apple TV and iPhone App Store and Google Play for Android devices. Top of the Wire Introducing FrontRow: the camera re-invented. Watch BizWireTV to see more disruptors as well as the top 5 trending stories of the week! A core c
PsiOxus Therapeutics Announce Two New Board Appointments: New Board Appointments Strengthen Company’s US Presence17.8.2017 07:00 | Pressemelding
PsiOxus Therapeutics, Ltd. (PsiOxus) today announced the appointment of Charles Rowland and Duncan Higgons to the Board of Directors as part of an ongoing drive to expand in the US. Charles Rowland was most recently the President and Chief Executive Officer (CEO) of Aurinia Pharmaceuticals, a clinical stage pharmaceutical company focused on the global lupus nephritis market. Prior to this, he served as the Vice President and Chief Financial Officer (CFO) of ViroPharma, during which time the company grew into a global biopharmaceutical business with $500 million in annual revenues until it was acquired by Shire plc for $4.2 billion. Before joining ViroPharma, Mr. Rowland was executive Vice President, CFO, and interim co-CEO, for Endo Pharmaceuticals. In his earlier career, Charles held finance and operational positions at Biovail Pharmaceuticals, Breakaway Technologies, Pharmacia
Smarsh Adds Voice Archiving Offering with Acquisition of London-Based Cognia17.8.2017 06:59 | Pressemelding
Smarsh®, providing information archiving solutions for compliance, e-discovery and risk management, has completed the acquisition of Cognia, a worldwide leader in cloud-based voice archiving, audio search and analytics. Smarsh will leverage Cognia’s intellectual property and development resources to offer its global customer base enhanced capabilities around mobile and fixed-line voice communication – alongside a market-leading range of electronic communications – within The Archiving Platform. The acquisition will expand the existing presence of Smarsh in Europe and is central to its MiFID II compliance solution for financial firms. In addition to capturing incoming and outgoing communication from fixed-line recording solutions, Cognia uniquely captures voice content directly from leading mobile carriers. Carrier-direct capture is the most reliable and automated method for capt
Schlumberger Announces Third-Quarter 2017 Results Conference Call16.8.2017 21:23 | Pressemelding
Schlumberger Limited (NYSE:SLB) will hold a conference call on October 20, 2017 to discuss the results for the third quarter ending September 30, 2017. The conference call is scheduled to begin at 8:30 am US Eastern time and a press release regarding the results will be issued at 7:00 am US Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (800) 288-8967 within North America or +1 (612) 333-4911 outside of North America approximately 10 minutes prior to the start of the call, and ask for the “Schlumberger Earnings Conference Call.” A webcast of the conference call will be broadcast simultaneously at www.slb.com/irwebcast on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call,
Rimini Street Named to Inc. 5000 List for Seventh Consecutive Year16.8.2017 18:20 | Pressemelding
Rimini Street, Inc., a global provider of enterprise software products and services, and the leading independent support provider for Oracle and SAP products, today announced that it was named to Inc. magazine’s 36th annual Inc. 5000 list for the seventh consecutive year. The Inc. 5000 list is an exclusive ranking of the nation’s fastest-growing private companies and represents the most comprehensive look at America’s entrepreneurs. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170816005908/en/ Rimini Street has earned a place on the annual Inc. 5000 list since 2011, joining an elite group – approximately 2% – of Inc. 5000 honorees to ever achieve this milestone. (Photo: Business Wire) Rimini Street has earned a place on the annual Inc. 5000 list since 2011, joining an elite group – approximatel
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom