ECFS

Vertex Presents New Data at the European Cystic Fibrosis Conference Demonstrating Significant Benefits of Treatment with TRIKAFTA®

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금요일, 6월 7, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, European, CFTR, VRTX, Vertex Pharmaceuticals, Abstract, German, Concurrency, Cystic fibrosis, Elexacaftor/tezacaftor/ivacaftor, Safety, Death, ECFS, Conference, Concentration ratio, Vertex, Pharmaceutical industry

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that data on TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), also known in the European Union and in the U.K. as KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor, were presented at this year’s European Cystic Fibrosis Society’s (ECFS) 47th European Cystic Fibrosis Conference held June 5-8, 2024, in Glasgow, Scotland.

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that data on TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), also known in the European Union and in the U.K. as KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor, were presented at this year’s European Cystic Fibrosis Society’s (ECFS) 47th European Cystic Fibrosis Conference held June 5-8, 2024, in Glasgow, Scotland.
  • Data from a randomized, double-blind, Phase 3 study (abstract WS06.04) demonstrated that people with CF who have rare, non-F508del mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene responsive to TRIKAFTA® in vitro demonstrated clinical benefit from receiving TRIKAFTA®.
  • Safety and tolerability were generally consistent with the established safety profile of TRIKAFTA®.
  • Ineligible Cohorts in the US Cystic Fibrosis Foundation Patient Registry (CFFPR) During COVID-19”
    Abstract P072, entitled “Real-World Impact of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Italy: A Retrospective Study From a CF Center”

4DMT Reports First Quarter 2024 Financial Results and Operational Highlights

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목요일, 5월 9, 2024
FDA, Regenerative medicine, Research, Choroideremia, Biopsy, European Medicines Agency, Injection, Overalls, Inflammation, Food, Alpha-1 antitrypsin, Cystic fibrosis, Chelsea Handler, Intravitreal administration, Conference, Retina, Atypical hemolytic uremic syndrome, DME, Angiogenesis, PRISM, AMD, Safety, Security (finance), Cash, Retinitis pigmentosa, Exercise, PRIME, EMA, NHP, Clinical trial, A1AT, ASRS, ARVO, ECFS, Șaeș, Cubic foot, Patient, Society, Geographic atrophy, Pharmaceutical industry

“The first quarter of 2024 kicks off another transformative year for 4DMT with exceptional progress across our product pipeline and platform in multiple therapeutic areas, particularly our lead program 4D-150 in large market VEGF-driven retinal diseases,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.

Key Points: 
  • “The first quarter of 2024 kicks off another transformative year for 4DMT with exceptional progress across our product pipeline and platform in multiple therapeutic areas, particularly our lead program 4D-150 in large market VEGF-driven retinal diseases,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.
  • R&D Expenses: Research and development expenses were $27.9 million for the first quarter of 2024, as compared to $22.4 million for the first quarter of 2023.
  • G&A Expenses: General and administrative expenses were $10.3 million for the first quarter of 2024, as compared to $8.0 million for the first quarter of 2023.
  • Net Loss: Net loss was $32.4 million for the first quarter of 2024, as compared to net loss of $28.7 million for the first quarter of 2023.

4DMT Announces Update on Regulatory Interactions and Development Path for 4D-710 for Treatment of Cystic Fibrosis

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목요일, 3월 28, 2024
CDMO, Conference, TDN, Patient, Lung, Cohort, RNA, EMA, Technology transfer, Cystic fibrosis, European Medicines Agency, GMP, Clinical trial, ECFS, Safety, CFTR, AMD, Food, FDA, VG, Pharmaceutical industry

Phase 3 clinical endpoints include changes after 4D-710 treatment in ppFEV1, quality-of-life (Cystic Fibrosis Questionnaire Revised Respiratory Domain, CFQ-R-RD) and frequency of pulmonary exacerbations.

Key Points: 
  • Phase 3 clinical endpoints include changes after 4D-710 treatment in ppFEV1, quality-of-life (Cystic Fibrosis Questionnaire Revised Respiratory Domain, CFQ-R-RD) and frequency of pulmonary exacerbations.
  • The Company anticipates initiation of technology transfer to a commercial contract development and manufacturing organization (CDMO) in H1 2025.
  • Our goal is to initiate Phase 3 development in H2 2025 with 4D-710 suspension GMP process clinical trial material.
  • We look forward to sharing interim clinical data from the AEROW Phase 1/2 clinical trial at the ECFS conference in June 2024.”

Liberty Networks Deploys Taara’s Wireless Optical Communication Technology To Increase High-Capacity Connectivity In The Eastern Caribbean Region

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수요일, 11월 1, 2023
Data Management, Technology, Telecommunications, Mobile, Wireless, Software, Networks, Internet, Data-rate units, LLA, European Civil Liberties Network, SVP, Atmosphere, Maintenance, ECFS, Multimedia, Network, Communication, Infrastructure, Strategic management, Video game, Shipbuilding, Tharapita

Liberty Networks , a leading infrastructure and enterprise connectivity provider in Latin America and the Caribbean, part of Liberty Latin America (LLA), announced today that it had successfully deployed Taara ’s wireless optical communication technology to enhance high-speed data connection between two Caribbean islands.

Key Points: 
  • Liberty Networks , a leading infrastructure and enterprise connectivity provider in Latin America and the Caribbean, part of Liberty Latin America (LLA), announced today that it had successfully deployed Taara ’s wireless optical communication technology to enhance high-speed data connection between two Caribbean islands.
  • We see further use cases for this cutting-edge technology following this successful deployment.”
    “We were honored to help Liberty Networks to quickly deploy fiber-like connectivity using Taara’s wireless optical solution.
  • Liberty Networks is committed to leveraging innovative technologies to deliver reliable, high-performance connectivity solutions.
  • The company continues to connect communities and transform lives through strategic partnerships and new approaches to connectivity.

BiomX Announces Completion of Patient Dosing in Part 2 of the Phase 1b/2a Study Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis

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수요일, 10월 4, 2023
Part 1, Trial of the century, Phage therapy, Cystic fibrosis, Part, ECFS, Fright Night Part 2, ERS, Pseudomonas aeruginosa, Congress, Patient, Randomness, Nebulizer, European Respiratory Society, NESS, CF, NYSE, Pharmaceutical industry

CAMBRIDGE, Mass. and NESS ZIONA, Israel, Oct. 04, 2023 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the completion of patient dosing in Part 2 of the Phase 1b/2a trial evaluating the Company’s novel phage cocktail, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis (“CF”). The Company remains on track to report results from Part 2 of the study in November 2023.

Key Points: 
  • and NESS ZIONA, Israel, Oct. 04, 2023 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the completion of patient dosing in Part 2 of the Phase 1b/2a trial evaluating the Company’s novel phage cocktail, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis (“CF”).
  • The Company remains on track to report results from Part 2 of the study in November 2023.
  • “BX004 has been designed to address a significant unmet need facing thousands of CF patients who require new treatments to combat persistent and deadly lung infections,” said Jonathan Solomon, Chief Executive Officer of BiomX.
  • “With patient dosing now complete in Part 2 of our Phase 1b/2a study, we remain on track to announce results next month.

4D Molecular Therapeutics Reports Second Quarter 2023 Financial Results and Operational Highlights

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수요일, 8월 9, 2023
Well, PRISM, ARVO, DME, AMD, Clinical trial, Fabry disease, ASRS, Completeness, Cash, ECFS, Șaeș, CFTR, Patient, Security (finance), CST, Infrared spectroscopy correlation table, Research, Macular degeneration, D, Pharmaceutical industry, Life insurance, Vaccine, 3D printing, Astellas Pharma

“We are excited by the significant progress we have made across our large market product candidate portfolio in the second quarter,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.

Key Points: 
  • “We are excited by the significant progress we have made across our large market product candidate portfolio in the second quarter,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.
  • R&D Expenses: Research and development expenses were $23.6 million for the quarter ended June 30, 2023 as compared to $20.4 million for the second quarter of 2022.
  • G&A Expenses: General and administrative expenses were $8.8 million for the quarter ended June 30, 2023 as compared to $8.2 million for the second quarter of 2022.
  • Net Loss: Net loss was $29.6 million for the quarter ended June 30, 2023, as compared to $28.1 million for the second quarter of 2022.

4DMT Presents Positive Interim Data from Aerosolized 4D-710 Phase 1/2 AEROW Clinical Trial in Patients with Cystic Fibrosis at the ECFS 46th Annual Meeting

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수요일, 6월 7, 2023
DNA, Interim, Pediatrics, CET, National Jewish Health, VG, B cell, Epithelium, Clinical trial, Quality of life, MSCS, Cystic fibrosis, Cell, RNA, Cystic fibrosis transmembrane conductance regulator, ECFS, IHC, Lung, CFTR, Biomarker, Annual general meeting, Webcast, Immunohistochemistry, Patient, CF, Conference, Fatigue, Disease, Pharmaceutical industry, Vaccine, Phosphorus, MD, Medicine

ET with cystic fibrosis specialist Dr. Jennifer L. Taylor-Cousar

Key Points: 
  • ET with cystic fibrosis specialist Dr. Jennifer L. Taylor-Cousar
    EMERYVILLE, Calif., June 07, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced positive interim clinical data from the 4D-710 Phase 1/2 AEROW clinical trial for the treatment of cystic fibrosis lung disease.
  • 4D-710 is comprised of our targeted and evolved vector, A101, and a codon-optimized CFTR∆R transgene and is designed for aerosol delivery to achieve CFTR expression within lung airway epithelial cells.
  • Interim data from the study will be presented in an oral presentation titled, “AAV mediated gene therapy for cystic fibrosis: Interim results from a Phase 1/2 clinical trial,” at the European Cystic Fibrosis Society (ECFS) 46th Annual Meeting held in Vienna, Austria on Thursday, June 8 at 5:00 p.m. CET (11:00 a.m.
  • “We believe that 4D-710 represents a potentially transformative new treatment for people with CF.

Vertex Presents Data Demonstrating Significant Benefits of Long-Term Treatment With CFTR Modulators at the European Cystic Fibrosis Conference

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금요일, 6월 9, 2023
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, VRTX, Life, Observational study, Vertex, German, Quality of life, IA, Mutation, Cystic fibrosis, Medicine, ECFS, CFTR, Assistance, Cystic fibrosis transmembrane conductance regulator, European, Elexacaftor/tezacaftor/ivacaftor, Ageing, Hôpital Cochin, CF, Death, Conference, Safety, Vertex Pharmaceuticals, Pharmaceutical industry, Birth control

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 12 scientific abstracts on the company’s portfolio of cystic fibrosis (CF) medicines were presented at this year’s European Cystic Fibrosis Society's (ECFS) 46th European Cystic Fibrosis Conference held June 7-10, 2023, in Vienna, Austria.

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 12 scientific abstracts on the company’s portfolio of cystic fibrosis (CF) medicines were presented at this year’s European Cystic Fibrosis Society's (ECFS) 46th European Cystic Fibrosis Conference held June 7-10, 2023, in Vienna, Austria.
  • Together, the data presented show the long-term benefits of treatment with CFTR modulators as well as the importance of treating the underlying cause of CF as early in life as possible.
  • Key data presented at this year’s conference are highlighted below.
  • “The data on TRIKAFTA in particular demonstrate that this medicine improves lung function sustainably and in a real-world setting.

4DMT to Present Interim Data from 4D-710 Phase 1/2 AEROW Clinical Trial for Cystic Fibrosis Lung Disease at the European Cystic Fibrosis Society (ECFS) 46th Annual Meeting

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수요일, 5월 24, 2023
Modulation, Pediatrics, CET, National Jewish Health, VG, Cohort, Epithelium, Clinical trial, MSCS, Cystic fibrosis, ECFS, AAV, CFTR, Science, Patient, Webcast, Safety, FEV1, Disease, Communications satellite, Vaccine, Pharmaceutical industry, MD, Medicine

ET

Key Points: 
  • ET
    EMERYVILLE, Calif., May 24, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced an oral presentation of the interim data from the 4D-710 Phase 1/2 AEROW clinical trial for the treatment of cystic fibrosis lung disease at the European Cystic Fibrosis Society 46th Annual Meeting held in Vienna, Austria on June 7-10, 2023.
  • Clinical data will focus on safety, tolerability, pulmonary function testing (percent predicted FEV1) and respiratory-related quality of life assessments (Cystic Fibrosis Questionnaire-Revised or CFQ-R, Respiratory Domain Score).
  • The presentation will also include biomarker data on expression of the cystic fibrosis transmembrane regulator (CFTR) transgene protein from the endobronchial lung biopsies & brushings collected at week 4-8 after dosing.
  • ET to discuss the interim clinical data and provide a program update.

C&W Networks Upgrades CFX-1 and EWC Submarine Cables with Ciena

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월요일, 9월 26, 2022
Networks, Internet, Hardware, Technology, Telecommunications, ISP, Amerigo Vespucci, Investor, Virgin Islands, Antilles, Cable & Wireless Communications, Americas II, NYSE, ECFS, Blog, Control, Head, LinkedIn, LATAM, News, British Virgin Islands, Review, Internet, Telecommunication, IP, PCCS, Forward-looking statement, Pacific Caribbean Cable System, Ownership, Automation, Solution, Wireless, General manager, EC, Dominican Republic, CIEN, SSCS, EWC, MCP, Cable, SEC, Adaptation, MPLS, Disclosure, CBUS, Cable television, Airline, Network equipment, Limited, Ciena

These network upgrades will help address the soaring bandwidth needs of C&W Networks telco and internet service provider (ISP) customers.

Key Points: 
  • These network upgrades will help address the soaring bandwidth needs of C&W Networks telco and internet service provider (ISP) customers.
  • C&W Networks operates the largest submarine multi-ring fiber-optic network in the greater Caribbean, Central American and Andean regions, providing reliable connectivity to approximately 40 countries.
  • C&W Networks submarine cables cross the ocean to bring the pan-Caribbean region new opportunities and economic growth through connectivity, said Ian Clarke, Vice President of Global Submarine Solutions, Ciena.
  • For updates on Ciena, follow us on Twitter @Ciena , LinkedIn , the Ciena Insights blog , or visit www.ciena.com .