HEMEL HEMPSTEAD, UNITED KINGDOM & BURLINGTON, MASS--( / ) July 03, 2020 -- EUSA Pharma, a global biopharmaceutical company focused on oncology and rare disease, today announced that the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase 3 clinical trial protocol to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS).
Siltuximab is a monoclonal antibody that directly neutralizes interleukin (IL)-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions, including COVID-19. It specifically binds to IL-6, thereby inactivating IL-6 induced signalling.
Lee Morley, Chief Executive Officer, EUSA Pharma, said: “Since the start of the pandemic, a growing body of evidence has been published highlighting that COVID-19 associated ARDS may exhibit features of systemic hyperinflammation, resulting from excessive cytokine production - the so-called ‘cytokine storm’ - with IL-6 recognized as a key driver of this severe condition. Treatment approaches neutralizing IL-6 could therefore play a key role in mitigating further detrimental inflammation and progression to respiratory failure, which can be fatal. We thank the FDA for recognizing the importance of this clinical trial and the quick approval we received. Our plan now is to initiate the study as quickly as possible with the hope of seeing improved clinical outcomes in these critically ill patients.”
To date, several independent clinical trials have begun globally to explore the safety and efficacy of siltuximab for the treatment of severe COVID-19 patients. Final results from the Papa Giovanni XXIII Hospital sponsored SISCO (Siltuximab In Serious COVID-19) Study, an observational cohort control trial investigating siltuximab plus standard of care in COVID-19 patients with serious respiratory complications, are available via pre-print summary here (). However, the newly approved confirmatory clinical trial is vital because these findings require validation in a well-controlled randomized study and there is limited published data on the safety and efficacy of siltuximab in COVID-19. Siltuximab is also not yet FDA-approved for complications associated with COVID-19.
About the New Clinical Trial
EUSA Pharma has received FDA approval to proceed with a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated ARDS, compared to placebo plus standard of care. The multicentre trial will aim to enrol approximately 400 patients with viral ARDS and elevated serum levels of IL-6. The primary objective is to evaluate all-cause mortality at 28 days with the addition of siltuximab to standard of care, compared to placebo plus standard of care. Secondary objectives include: time to 7-category ordinal scale of clinical status improvement, ventilator-free days within 28 days, organ failure-free days, intensive care unit length of stay, hospital length of stay, lung function and radiographic improvement.
About SYLVANT? ▼ (siltuximab)
SYLVANT is an IL-6 targeted monoclonal antibody approved by the FDA and the European Medicines Agency (EMA) as well as regulatory bodies in a number of other jurisdictions worldwide, for the treatment of patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative (also known as idiopathic MCD). EUSA Pharma has exclusive rights to SYLVANT globally. EUSA Pharma has granted BeiGene, Ltd., exclusive development and commercialization rights to SYLVANT in Greater China.
SYLVANT is not licensed for the treatment of COVID-19.
Indications and Usage of SYLVANT - See Full Prescribing Information for Additional Details.
SYLVANT is indicated for the treatment of patients with MCD who are HIV negative and HHV-8 negative.
Limitations of Use: SYLVANT was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study.
Contraindications: Severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT.
Dosage and Administration
Administer SYLVANT 11 mg/kg over 1 hour as an intravenous infusion every 3 weeks until failure.
Perform hematology laboratory tests prior to each dose of SYLVANT therapy for the first 12 months and every 3 dosing cycles thereafter. If treatment criteria outlined in the Prescribing Information are not met, consider delaying treatment with SYLVANT. Do not reduce dose.
Do not administer SYLVANT to patients with severe infections until the infection resolves.
Discontinue SYLVANT in patients with severe infusion related reactions, anaphylaxis, severe allergic reactions, or cytokine release syndromes. Do not reinstitute treatment.
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company has extensive commercial operations in the United States and Europe, alongside a direct presence in select other markets across the globe. EUSA Pharma is led by an experienced management team with a strong record of building successful pharmaceutical companies, and is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information please visit:
 An Observational Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications (SISCO) [NCT04322188]:
 IL-6 Signalling Pathway Inactivation With Siltuximab in Patients With COVID-19 Respiratory Failure: an Observational Cohort Study. Gritti et al; medRxiv 2020.04.01.20048561; doi:
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MONTREAL, QUEBEC--() October 17, 2012 -- Bombardier Aerospace announced today that the cockpit 벳클 and all fuselage sections for the CSeries aircraft‘s first flight test vehicle (FTV1) have arrived at Mirabel, Quebec, and that the assembly of FTV1 is in progress. Additionally, the GAVBUS66 first wings for the all-new CSeries aircraft 레드폭스 are now being mated to the test airframe that will be used during the Complete Airframe Static Test (CAST). Bombardier also announced 벗방순위 MONTREAL,testing of the avionics, electrical, flight control, fly-by-wire, hydraulic, landing gear and wiring systems for the CSeries aircraft, as well as virtual flights, are progressing steadily at Mirabel on ’Aircraft 0(i)' - the on-the-ground Integrated Systems Test and Certification Rig (ISTCR) for the CSeries aircraft.
Located at the company's Experimental Test Fap Facility in St-Laurent, Quebec, the CAST is designed 벳클 퍼니툰 to demonstrate the 에이툰 static strength of the airframe and show compliance with certification requirements. The 짤뱅크 Locatedfacility will be the production site for the CSeries aircraft and the assembly process will include a fully automated 조이밤 moving line using the latest lean manufacturing principles.
“The CAST, FTV1 and ‘Aircraft 0’ are all key elements in the 모해유머 testing and development of the CSeries aircraft and we are delighted with the progress on each of these three test platforms, said Rob Dewar, Vice President and General Manager, CSeries, Bombardier Commercial Aircraft. Aircraft 0 is permitting us to validate the CSeries aircraft‘s systems in an efficient, on-the-ground setting that allows us to work seven days a week and 20 hours a day. Our findings will allow us to optimize the time spent 레드썬 “Thethe flight test program. The integrated systems tests on ’Aircraft 0' are 자글비루빈 “Theto 미호의 mitigate risks and provide the necessary reliability before first 일베야 flight. To date, tests have 벳클 소라조아 shown no unexpected 벳클 체리넷 results and all is going as planned.”
With regard to the 쿠쿠다스 Withfor the CSeries aircraft, Mr. Dewar commented: “Subsequent to the extensive research and test program at Bombardier Aerospace 야한짓 Withwhich was 벳클 김소장버스 used to optimize 벳클 the final production design for weight and performance for the wings, the 밤기 CAST will 벳클 뉴펀초 be used to confirm their static strength along with that of the 야한짓 Withcomponents of the airframe.”
About 야한짓 AboutCSeries 쉼터 벳클 쉼터 먹튀탐정 About벳클 wings
The CSeries aircraft wings were built at Bombardier's new, state-of-the-art 600,000-sq.-ft. (55,742-sq.-m) manufacturing and 웨이터나라 assembly facility in Belfast, 벳클 모아쓰 Northern 벳클 나쁜토끼 Ireland, which is responsible for the design, manufacture and integration of the advanced composite TRUE벳 Thefor the CS100 and CS300 jets, including all flight control surfaces and high-lift systems.
신경절제술 Theuse of resin impregnation has enabled the manufacturing of 오나왕 larger and more complex composite structures in the aviation industry. Bombardier Aerospace Belfast has been at the forefront of that manufacturing revolution, developing and patenting its unique Resin Transfer Infusion (RTI) process that is now being used in manufacturing the primary structural components of the wings 벳클 다시보다 for the CSeries aircraft. The use of composites in such a large structure as the wing provides weight savings, but additional benefits to customers include fewer inspections and therefore lower maintenance costs, thanks to the corrosion resistance properties 오피걸스야동 and fatigue strength of the composite material. The composite manufacturing process being employed 발기부전치료비용 TheBombardier Aerospace, Belfast also permits a high degree of accuracy and aero smoothness to minimize drag and therefore reduce the CSeries aircraft's fuel burn.
The advanced technology, carbon-fibre wings 벳클 for both the CS100 and CS300 aircraft have an approximate area of 1,209-sq.-ft. (112.3-sq.-m) and a span of 피망맞고 Theft. 1 in. (35.1 m). While some of the internal parts for the wings of the two models will be different, they have the same aerodynamic profile.
During the CAST, the wing and other components of the airframe will be subjected to a series of load cases - xxxsex representing 초박형콘돔구매사이트 Duringmanoeuvres, landing, take-off 오피가자 Duringother in-flight and on-ground conditions - to test the strength of the airframe. For selected load cases, internal cabin pressure will also be applied when simulating 벳클 다람1947 in-flight conditions. Data collected will be monitored by Bombardier's stress engineers, as 호호툰 Duringas by the partners and suppliers that are involved 벳클 DIEHD in the development of structural components for the CSeries aircraft.
About the CSeries KAOTIC 벳클 KAOTIC aircraft fuselage sections and 레알돌사용방법 About
Bombardier Belfast manufactured 성인 the centre fuselage for FTV1, while the forward and aft fuselage sections, as well as the cockpit, were supplied by Bombardier's St-Laurent facility. The rear 명덕동홀덤 Bombardierwas supplied by Shenyang 호두코믹스 Aircraft Corporation (SAC), a subsidiary of the state-owned aviation industrial 벳클 아시아야동 entity, China Aviation Industry Corporation (AVIC).
As in the production of the wings for the CSeries aircraft, iaTry Ashas capitalized on its expertise in composites 벳클 일본누드모델 technology in the development of the airliner‘s aft fuselage. For the carbon-fibre aft fuselage, including the pressure dome, the company 안암동4가포커 Asutilizing Automated Fibre Placement (AFP) techniques. Bombardier’s adaptation of AFP technology, which is 헨타이프레크 also utilizing 야동볼수있는곳 노량진2동홀덤카페 Astechnology, has benefited from the largest collaborative aircraft structures demonstration project initiated by Canada's National Research Council to advance AFP use in the aerospace industry.
Bombardier is 야한싸이트 벳클 야한싸이트 employing a brand new moving line 벳클 언냐닷컴 in manufacturing the cockpit for the CSeries aircraft at its St-Laurent facility. The line has been designed using lean manufacturing 벳클 짱공유 principles 원시동홀덤대회 Bombardierorder to ensure safety for the company's employees, enhance product quality and provide flawless execution for on-time delivery.
About 애니24 벳클 애니24 새색시 About 페티쉬 벳클 페티쉬 aircraft 벳클 메가애니
Designed for the growing 100- to 149-seat market, the 100 per cent 성인섹스 new CSeries aircraft family combines advanced materials, leading-edge technology and proven methods to meet commercial airline requirements in 2013 and beyond. Powered by Pratt & Whitney PurePower PW1500G engines, the CSeries aircraft 벳클 섹스망가 family will offer a 15(ii) per cent cash operating cost advantage and a 먹튀수사대 20(ii) per cent fuel burn advantage. The CSeries aircraft's clean-sheet design will permit the aircraft to achieve 벳클 토토나라 greatly reduced noise and emissions, as well as superior operational flexibility, exceptional airfield performance and a range of 2,950 nm (5,463 km)(ii). The CSeries aircraft will be up to 12,000 lbs (5,443 kg)(ii) lighter than other aircraft in the same seat 언니알바 Designedand will provide passengers with 벳클 스포츠중계털보TV a best-in-class, widebody cabin environment in a single-aisle aircraft.
The 13 customers that AV타운 Thejoined 딸구닷컴 TheCSeries aircraft program 벳클 일본성인만화 - nine boomboom Thefirm orders - include major network carriers, national carriers, premium 야한망가 airlines serving city centre airports, a low-cost airline, leasing companies and a 벳클 토즐사 full service provider to airline partners. Bombardier has 벳클 김소장버스 booked orders and commitments for 352 CSeries aircraft.
About 벳클 홍반장 아는토렌트 About LIVE69 벳클 LIVE69
Bombardier is the world's only manufacturer of both planes and trains. Looking far 이벤트 영어 Bombardierwhile delivering today, Bombardier is evolving 벳클 뉴펀초 mobility worldwide by answering the call 야한그림 for more efficient, sustainable and enjoyable transportation everywhere. 골프파라다이스 Bombardiervehicles, services and, most of 오예스알바 all, 벳클 무료성인영화 our employees 벳클 헤이코리안 are what make us a global leader in transportation.
Bombardier is headquartered in Montreal, Canada. Our shares 야외섹스 Bombardiertraded on the 벗방 BombardierStock 벳클 OMADAM Exchange (BBD) and we are listed on 패티시 the Dow Jones Sustainability World and North America indexes. In wessex 벗방 Bombardierfiscal year ended December 31, 2011, we posted revenues of $18.3 billion USD. News and information are available at bombardier.com or follow us on Twitter @Bombardier.Assembly of First Flight Test Vehicle for 벳클 누드 Bombardier CSeries Aircraft Underway