TRIO Awarded NATALEE Study, Largest Single Phase III Breast Cancer Clinical Trial in its History
Ribociclib Combination Therapy in Adjuvant Setting Represents A Promising Therapy Against Breast Cancer
EDMONTON, Alberta, July 09, 2018 (GLOBE NEWSWIRE) -- Translational Research In Oncology (TRIO) today announced a collaboration with Novartis on its upcoming phase III clinical trial of ribociclib with endocrine therapy in the adjuvant treatment of HR-positive, HER2-negative early breast cancer (EBC). The trial will be called NATALEE (New Adjuvant TriAl with LEE).
"Ribociclib in combination with hormonal therapy has been demonstrated to be an effective treatment for advanced breast cancer in three large, Phase III clinical trials as well as in clinical practice around the world," says Samit Hirawat, MD, Executive Vice President, Head of Novartis Oncology Global Drug Development. "We are pleased to collaborate with TRIO, its study investigators and patients to advance ribociclib in combination with endocrine therapy as a potential new treatment option for patients with early-stage breast cancer."
This randomized, phase III study will include more than 4,000 patients from around the world. By mobilizing the strength of TRIO's investigator sites within its global network, including TRIO-US and its regional partners, TRIO aims to complete enrolment rapidly. The primary endpoint of the study is invasive disease-free survival (iDFS).
Ribociclib belongs to a class of therapies called CDK4/6 inhibitors. Cyclin-dependent kinases 4 and 6 are proteins that help regulate cell replication and proper cell cycle function. Overexpression of CDK4/6 has been observed in certain cancers, and this leads to uncontrolled cell growth contributing to tumour formation. CDK4/6 inhibitors prevent CDKs from triggering cell growth and division, leading to the death of the cell.
"This collaboration represents the largest single trial awarded to TRIO and speaks to the confidence Novartis has in our capabilities and our global clinical trial network," says Dennis J. Slamon, MD, PhD, TRIO Chairman/Executive Director and Director of Clinical Translational Research at the University of California, Los Angeles Jonsson Comprehensive Cancer Center. "Ribociclib with endocrine therapy is an exciting addition to the world of cancer therapies. Maintaining disease-free survival and quality of life in breast cancer patients guides all of our research."
TRIO's experience with breast cancer clinical trials is well-established, having been involved in the development of trastuzumab for HER2-positive breast cancer, docetaxel for early-stage breast cancer, and other CDK4/6 inhibitors. TRIO's commitment to breast cancer positions them as leaders in the field, with a long-standing desire to improve the lives of people with breast cancer.
This clinical trial will provide insight into the role of ribociclib in EBC. The efficacy, safety, and validity of ribociclib in the treatment of present and future EBC patients is the ultimate goal of TRIO and Novartis.
Ribociclib was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.
TRIO advances translational cancer research by introducing innovative and novel targeted therapeutic concepts into the clinical trial setting. With international offices in Edmonton (Canada), Paris (France), Montevideo (Uruguay), TRIO's global reach is expansive. Our goal as a clinical research organization is to find the shortest path to saving lives. Additional information on TRIO can be found by visiting https://www.trioncology.org. Interested parties may also follow TRIO on Twitter (twitter.com/TRIOncology).
For more information, contact:
Launa Aspeslet, PhD, RAC
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Translational Research in Oncology via Globenewswire
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
Service Providers Speed Deployment, Reduce Costs with Patton Cloud Edge Orchestration Service20.9.2018 22:16 | Pressemelding
Now, Telecom and UCaaS service providers can easily provision, manage, monitor, secure, alert, troubleshoot, analyze, and optimize services on the customer premise GAITHERSBURG, Md., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Patton Electronics—US-manufacturer of UC, cloud, and IoT-enabling solutions for carrier, enterprise, and industrial networks—has launched the new Patton Cloud service for carriers and service providers that deliver All-IP and hybrid voice-and-data services to business subscribers. Patton Cloud delivers a low-cost, easy-to-use, web-based edge-orchestration service that delivers a superior user experience. It offers remote touchless provisioning, monitoring, and troubleshooting—as well as security and alerting tools that reduce service turn-up costs, trouble tickets, and subscriber attrition. The Patton Cloud service offers quality-control mechanisms including pro-active monitoring and troubleshooting—combined with feature-license distribution pools for managing value-added
Inspirata Promotes Top Executives to Expanded Roles in Digital Pathology20.9.2018 21:12 | Pressemelding
Inspirata Founder and Executive Vice President, Mark Lloyd, is taking on an expanded role overseeing product management, and Inspirata Senior Vice President, Andrew Chomos, has been appointed to General Manager, Digital Pathology, overseeing the Center of Excellence in Pittsburgh along with all North America sales and customer support efforts. Tampa, FL, Sept. 20, 2018 (GLOBE NEWSWIRE) -- Cancer informatics and digital pathology workflow solution provider Inspirata®, Inc. announced today that two of its executives have taken on expanded roles in the company. The two are Inspirata Executive Vice President and Founder, Mark Lloyd, and Senior Vice President and General Manager, Digital Pathology, Andrew Chomos. Dr. Lloyd has accepted the expansion of his role to include product management for Digital Pathology. He is former cancer researcher at both Lombardi Cancer and Moffitt Cancer Center and is Inspirata’s foremost subject matter expert and thought leader on digital pathology and image
Tetraphase Pharmaceuticals Announces Adoption of Commission Decision Granting Marketing Authorisation Approval in the European Union for XERAVA™ (eravacycline) for the Treatment of Complicated Intra-Abdominal Infections20.9.2018 19:08 | Pressemelding
– Broad Product Label for Treatment of Complicated Intra-Abdominal Infections – – Phased Commercial Launch Expected in the First Half of 2019 – WATERTOWN, Mass., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that the European Commission (EC) has adopted the Decision granting marketing authorisation for XERAVA (eravacycline) for injection for the treatment of complicated intra-abdominal infections (cIAI) in adults in the European Union. In clinical trials, XERAVA was well-tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical non-inferiority to two widely used comparators – ertapenem and meropenem. “The European approval of XERAVA, right after our recently announced FDA approval, marks our second significant regulatory approval within one month
UPDATE— Taconic Biosciences Becomes the First Animal Model Provider on General Services Administration Contract Schedule20.9.2018 18:07 | Pressemelding
RENSSELAER, N.Y., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Taconic Biosciences, a global leader in providing genetically engineered rodent model solutions, announces a new relationship with Government Scientific Source (GSS). GSS is a leading dedicated distributor of laboratory equipment to federal, state, and local governments on contract with the GSA (General Services Administration). By having Taconic’s products available via GSS, they can now be accessed by all federal agencies, including but not limited to the National Institutes of Health and the Department of Defense. Taconic is the only animal model provider affiliated with GSS and the only animal model provider available on GSA Contract. “An important component of providing customers with the best animal model solutions is access to key resources. Through this exciting new relationship with GSS, Taconic can now easily connect with scientists doing some of the most valuable research in the world and provide them with high quality sol
Digital Transformation is Not a One-Off — It’s About the Digital Journey20.9.2018 17:44 | Pressemelding
SoftServe study confirms four digital journey states with 71 percent of enterprises reporting early stages of adoption AUSTIN, Texas, Sept. 20, 2018 (GLOBE NEWSWIRE) -- SoftServe, a leading digital authority and consulting company, today released the results of its market research study that examines how enterprises are responding to the digital economy. The research found that 71 percent of the respondents in the United States and the European Union are in the early stages—Reveal and Transform—of four unique states across the Enterprise Digital Journey. For an in-depth analysis and the full results, read The Enterprise Digital Journey white paper. With fierce competition in today’s global landscape, leveraging cutting-edge technology and deploying new business models is not a one-off pursuit, but rather a continuous process of iteration and refinement. Companies should stop referring to Digital Transformation and instead plan for a continuous Digital Journey. “The term Digital Transfo
Anomali Announces Major Expansion of Threat Platform Partner Ecosystem20.9.2018 16:00 | Pressemelding
New Developer SDKs enable partners to integrate solutions with Anomali Threat Platform NATIONAL HARBOR, Md., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Anomali today announced at the Detect Conference 2018 the expansion of the partner ecosystem with the launch of a suite of partner developer resources. The new tools enable easier and faster integration with the Anomali Threat Platform and APP Store, allowing clients immediate access to partner content, integrations and analytics. The partner program expansion includes the launch of a suite of software development kits (SDKs). The SDKs address three critical integration areas: Threat Intelligence Feeds SDK: integrate proprietary threat intelligence feeds and make these accessible via the APP Store Integration SDK: integrate threat intelligence from the Anomali Threat Platform into third party products and solutions Enrichment SDK: integrate 3rd party threat analysis and data enrichments into the Anomali Threat Platform “Organizations need a com
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom