Business Wire

FDA Allows WIN Consortium to Proceed with Targeted Tri-Therapy Clinical Trial in First Line Treatment of Metastatic Non Small Cell Lung Cancer

Jaa

WIN Consortium (WIN) received the US Food and Drug Administration (FDA)’s approval to start the clinical investigation of a novel therapeutic approach using a combination of three targeted therapies for the first line treatment of patients with advanced Non Small Cell Lung Cancer (NSCLC). The S urvival P rolongation by R ationale In novative G enomics (SPRING) trial will aim to enroll patients who are usually offered first line platinum-based chemotherapy. Patients with documented targetable driver alterations (EGFR mutations, ALK rearrangements, ROS1 and MET exon 14 skipping mutations) will be excluded. The population of NSCLC patients without actionable oncogenic driver mutations, envisioned for the enrollment in SPRING trial, represents the vast majority of patients with metastatic NSCLC (~80% in the Caucasian population).

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170809005432/en/

The Members of WIN Consortium (Graphic: WIN Graphic Design)

The Members of WIN Consortium (Graphic: WIN Graphic Design)

With over 60% of NSCLC detected in an advanced or metastatic stage, and less than 5% of patients alive at 5 years, a paradigm changing strategy for treating the deadliest cancer is needed. WIN’s novel approach is based on the utilization of the tri-therapy combination of targeted drugs, following the historical success of this approach in AIDS and tuberculosis. Similarly, our concept relies on the association of three targeted drugs that used in combination are expected to be highly potent, whereas used alone in monotherapy they produce only modest clinical outcome.

’Nevertheless, it is important to acknowledge a significant difference between cancer and AIDS which lies in the higher biological complexity and heterogeneity of cancer compared to AIDS. In AIDS, one tri-therapy combination is effective for a majority of patients, whereas in cancer it is expected that many combinations will be needed to treat all patients effectively. WIN Consortium has developed new technologies for tailoring combinations for each individual patient.’’ said Dr. John Mendelsohn, Chairman of WIN. "WIN’s trial, entitled SPRING, is therefore a first proof of concept of this novel approach in the treatment of lung cancer, and will test as a first combination three drugs from WIN’s big pharma members, Merck’s Avelumab combined with Pfizer’s Palbociclib and Axitinib.’’ added Dr. Mendelsohn.

SPRING’s investigator initiated research will be led by Dr. Razelle Kurzrock (University of California San Diego, Moores Cancer Center) and co-led by Dr. Enriqueta Felip (Vall d'Hebron Institute of Oncology) and is planned to be launched in 5 countries and 8 WIN member sites: University of California San Diego Moores Cancer Center and Avera Cancer Institute (Dr. Benjamin Solomon), USA; Institut Curie (Dr. Nicolas Girard), Centre Léon Bérard (Dr. Pierre Saintigny) and Hôpital Paris Saint-Joseph (Dr. Eric Raymond), France; Vall d'Hebron Institute of Oncology, Spain; Centre Hospitalier de Luxembourg (Dr. Guy Berchem); and Chaim Sheba Medical Center (Dr. Jair Bar), Israel.

The SPRING trial will start with a Phase I portion to explore the safety of the combination and determine the optimal doses for the Phase II that will explore the efficacy of this tri-therapy regimen in first line treatment of metastatic NSCLC. The trial will also aim to validate a novel algorithm SIMS (Simplified Interventional Mapping System) developed by WIN and designed to match each patient’s tumor biology to a specific drug combination. For this purpose, both tumor and normal lung tissue biopsies will be obtained and explored in the SPRING trial. DNA and RNA analysis will be performed by Dr. Brandon Young at Avera WIN Precision Oncology Laboratory in San Marcos, California on biopsies using, respectively, Illumina NGS (next generation sequencing) and HTG Molecular’s expression (mRNA and microRNA) EdgeSeq technology used in conjuction with Illumina (NGS). Data integration for the SIMS algorithm will be performed by Ben-Gurion University of the Negev (Dr. Eitan Rubin), Israel.

’It is an unprecedented cooperation between our WIN members from academia, industry and research organizations.“ said Dr. Vladimir Lazar, WIN Chief Scientific and Operating Officer. ‘’Eight clinical sites will activate the study, drugs will be provided by Pfizer Inc., DNA and RNA analysis technologies by Illumina and HTG Molecular and pharmacovigilance by Covance. In particular, we are grateful to Foundation ARC on cancer research in France for financial support to initiate the SPRING trial. We are welcoming the support of any other organization or private donors, wishing to join this unique global effort dedicated to lung cancer patients.’’ added Dr. Lazar.

’It is very exciting to see this endeavor becoming more concrete and this unprecedented cooperation materializing. We are looking forward to the activation of our clinical sites. We will need more combinations to be launched rapidly and other pharma companies to join us in this effort.’’, said Dr. Razelle Kurzrock, trial global coordinator, and Head of WIN Clinical Trials Committee. ‘’WIN has the potential and expertise to test other combinations and has the technologies needed to match patients’ tumor biology profile with the appropriate combination”.

About WIN Consortium
WIN Consortium is a French based non-profit network of 41 world-class academic medical centers, industries (pharmaceutical and diagnostic companies), health payer, research organizations and foundation and patient advocates spanning 17 countries and 4 continents, aligned to deliver now the progress in cancer treatment that is awaited by so many patients and families around the world.

For further information, please visit www.winconsortium.org.

Contact information

WIN Consortium
Catherine Bresson:
Director Operational Team
catherine.bresson@winconsortium.org
or
Vladimir Lazar, Tel: +33661091522
Chief Scientific and Operating Officer
vladimir.lazar@winconsortium.org

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Edgewater Networks Announces Event Sponsorship of BroadSoft Connections 201721.10.2017 00:00Tiedote

Edgewater Networks, Inc., the industry leader in Network Edge Orchestration, announced today that it is an event sponsor of the BroadSoft Connections 2017 user conference, which takes place October 22-25 at the JW Marriott Phoenix Desert Ridge Resort & Spa in Phoenix, AZ. During the event, Edgewater Networks will feature demonstrations of the latest end-to-end network interoperability capabilities, including Zero Touch Provisioning, UC Analytics from the core to the endpoint, SD-WAN optimized for BroadSoft, and much more. Continuing a long-standing partnership with BroadSoft, Edgewater Networks has completed another level of BroadCloud certification, this time for local survivability which is critical for business continuity for SMB and Enterprise customers. BroadSoft’s PacketSmart is available on all EdgeMarc Intelligent Edges. All elements of the Network Edge Orchestration are

More than 70 Companies to Showcase Top Tech at CES Unveiled Paris20.10.2017 18:08Tiedote

The Consumer Technology Association (CTA) today announced that more than 70 exhibitors will showcase their latest innovations at the now sold-out fifth annual CES Unveiled Paris The event will focus on the Internet of Things (IoT), connectivity and smart cities, and draw more than 600 attendees. CES Unveiled Paris will run from 2-7:30 PM on Tuesday, October 24, 2017 at the Palais Brongniart. Regional technology companies, top-tier media outlets, buyers and key industry influencers will come together at CES Unveiled Paris to get a direct look at the latest industry developments. The day kicks off with a CES news conference and CTA market trends presentation. Conference programming is followed by a tabletop exhibition & networking reception. Curated exhibitors will be there to showcase top tech from robotics and audio to smart home and augmented and virtual reality. Notable

Westinghouse Receives Regulatory Approval for Analysis Methodologies20.10.2017 15:15Tiedote

Westinghouse Electric Company today announced that it has received approval from the U.S. Nuclear Regulatory Commission (NRC) for two new important analysis methodologies that will be used to upgrade Westinghouse- and Combustion Engineering-based nuclear steam supply system (NSSS) safety analyses. The approvals granted are for the new FULL SPECTRUMTM Loss of Coolant Accident (FSLOCATM) methodology and the Performance Analysis and Design Model software code update, PAD5. FSLOCA is capable of improved modeling of the transient response in a pressurized water reactor to the full spectrum of LOCA break sizes that could occur, and PAD5 is the next generation of the Westinghouse fuel rod design performance code. “These codes were developed to work in concert with each other to maximize analytical margin for nuclear utilities,” said Michele DeWitt, senior vice preside

Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread®20.10.2017 15:03Tiedote

Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection, adding to the body of evidence supporting Gilead’s viral hepatitis therapies in diverse patient populations. These and other data from more than 25 abstracts will be presented this week at The Liver Meeting® 2017, which begins today in Washington, D.C. Positive results from studies of Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal impairment, Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) in HCV-infected liver transplant recipients and Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) in NS5A-inhibitor experienced HCV-infected patients will be presented during poster sessions on October 21 and October 22. In addition, updated results f

SP3H Announces That It Has Obtained a €1.2 Million European Union Grant for Its Intelligent and Clean Vehicle (VIP) Project20.10.2017 13:47Tiedote

SP3H is proud to announce joining the very select circle of the 10 French winners of the H2020 SME Instrument Phase 2 program since 2014. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171020005325/en/ Last summer VIP received the very prestigious SME instrument phase 2 H2020 label in the "transport & smart cities mobility" category. With an overall budget of € 1.7 million, VIP is subsidized by the European Union at a rate of 70% or €1.2 million. The framework contract was officially signed early October. VIP is the pre-industrialization program for Fuelbox sensors, the world's first miniaturized scanner capable of analyzing the quality of fuels on board vehicles. The heart of the program remains closely linked to the reduction of CO2 and pollutant emissions from vehicle

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme