Vital capacity

Pliant Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial Results

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月曜日, 5月 6, 2024
Idiopathic pulmonary fibrosis, FVC, Investment, Hospital, Safety, Primary sclerosing cholangitis, Research, IPF, Collagen, Trial of the century, PET, Acceleration, DMD, Tumor microenvironment, PSC, European, Novartis, Week, Therapy, Vital capacity, Muscular dystrophy, Patient, TGF, Fibrosis, Cirrhosis, Integrin, Duchenne muscular dystrophy, Biomarker, Ethics committee, Massachusetts General Hospital, ELF, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a late-stage clinical biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today provided a corporate update and reported first quarter 2024 financial results.

Key Points: 
  • As part of the adaptive Phase 2b/3 implementation, the Phase 2b portion of BEACON-IPF was upsized from 267 patients to 360 patients.
  • Enrollment is progressing and we expect to complete enrollment of the upsized Phase 2b study expected in the first quarter of 2025.
  • The increase was due to higher operating expenses coupled with a decrease in collaboration revenues under the Novartis agreement during the quarter.
  • As of March 31, 2024, the Company had cash, cash equivalents and short-term investments of $483.9 million.

LAWA'S TRAILBLAZING CONTRACTING MODEL FOR CAPITAL IMPROVEMENT PROJECTS BREAKS INCLUSIVITY RECORDS, SETS NEW STANDARDS

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月曜日, 4月 29, 2024
Proposal, Investment, Capital, Entitlement, Biophysical environment, LAX, Airport, Council, Van Nuys Airport, Vital capacity, LAWA, Los Angeles International Airport, VNY, Construction, Travel, XBE, Aviation, Interest, Airline

LOS ANGELES, April 29, 2024 /PRNewswire/ -- Los Angeles World Airports (LAWA)'s latest Multiple Award Task Order Contract (MATOC), representing nearly $1 billion in contracting value, received approval from Los Angeles City Council on April 26, 2024. The Council's endorsement follows earlier consent from the City of Los Angeles's Travel, Trade and Tourism Committee and LAWA's Board of Airport Commissioners (BOAC). The occasion marks a groundbreaking moment for LAWA and its dedication to creating new and lasting economic pathways for local, diverse, veteran, small and micro businesses with a historic number of first time and new-to-LAWA participants.

Key Points: 
  • LAWA's Trailblazing Contracting Model for Capital Improvement Projects Breaks Inclusivity Records, Sets New Standards
    "After supporting this game-changing MATOC with my fellow BOAC members, I commend the City on its unanimous decision to ratify this vital contract," said Karim Webb, President, Board of Airport Commissioners.
  • Previously, the Program Services MATOC had an inclusivity requirement of 20% for Small Business Enterprises (SBEs).
  • This contracting model eliminates the need to negotiate additional service terms, greatly increasing efficiencies for both contractors and the client.
  • LAWA's measurable inclusivity investments are fostering equitable economic growth and resiliency in Los Angeles and the greater Southern California region.

PureTech Announces Completion of Enrollment in Phase 2b ELEVATE IPF Trial of LYT-100 (Deupirfenidone) in Idiopathic Pulmonary Fibrosis

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火曜日, 4月 16, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, University of Southern California, FDA, Idiopathic pulmonary fibrosis, University, Vital capacity, FVC, Safety, Survival, IPF, CNS, Incidence, Patient, TID, Pirfenidone, Caregiver, Aes, Central nervous system, PRTC, Biomarker, Pharmacology, Pharmaceutical industry

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that enrollment has been completed in the ELEVATE IPF Phase 2b clinical trial evaluating LYT-100 (deupirfenidone) in patients with idiopathic pulmonary fibrosis (IPF).

Key Points: 
  • PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that enrollment has been completed in the ELEVATE IPF Phase 2b clinical trial evaluating LYT-100 (deupirfenidone) in patients with idiopathic pulmonary fibrosis (IPF).
  • This PK profile and the resulting favorable tolerability have been demonstrated across multiple clinical trials in more than 400 individuals.
  • PureTech believes the results of the Phase 2b trial, together with an additional Phase 3 trial, could serve as the basis for registration in the U.S. and other geographies.
  • PureTech would like to extend its gratitude to those participating in the ELEVATE IPF trial, especially the people living with IPF and their caregivers, the clinical trial sites, investigators and advocacy groups.

IASO Bio Announces U.S. FDA Approval of Investigational New Drug Application for BCMA CAR-T Equecabtagene Autoleucel for Generalized Myasthenia Gravis

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木曜日, 4月 4, 2024
Vital capacity, MuSK protein, Glucocorticoid, NMPA, Hormone, GMG, Disease, Chinese, MRS, BCMA, Nervous system, Patient, SAN, Enzyme inhibitor, History, Female, Multiple myeloma, CRS, B cell, Biotechnology, IND, Phenotype, Investigational New Drug, QMG, Safety, Thymectomy, FDA, Food

The Chinese IND for this indication of Equecabtagene Autoleucel was approved by the NMPA in January this year.

Key Points: 
  • The Chinese IND for this indication of Equecabtagene Autoleucel was approved by the NMPA in January this year.
  • The 2 subjects were treated with a single infusion of Eque-cel at the doses of 1.0×106 CAR-T/Kg, respectively.
  • No immunomodulatory therapy other than low dose pyridostigmine (90 mg/day and 60 mg/day, respectively) was used during the follow-up period.
  • Anti-AChR antibodies, anti-Titin antibodies, and anti-MuSK antibodies decreased rapidly and maintained at very low levels in both subjects after infusion.

C-Path Launches Clinical Trial Simulator for Duchenne Muscular Dystrophy Research

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木曜日, 3月 28, 2024
Research, Vital capacity, Atrophy, Disease, Data analysis, Letter, Pharming, Female, European Medicines Agency, Duchenne muscular dystrophy, Clinical trial, Drug development, FCP, FDA, DMD, CTS, Food, Pharmaceutical industry

This pioneering Drug Development Tool is set to positively impact the medical research community by significantly optimizing clinical trial design.

Key Points: 
  • This pioneering Drug Development Tool is set to positively impact the medical research community by significantly optimizing clinical trial design.
  • This Clinical Trial Simulator will positively impact DMD research by significantly optimizing clinical trial design.
  • "The launch of the DMD Clinical Trial Simulator represents a significant step forward in our fight against Duchenne muscular dystrophy," said Ramona Belfiore-Oshan, Ph.D., Executive Director for D-RSC.
  • Granting access to the D-RSC Clinical Trial Simulator through RDCA-DAP creates a unique opportunity for innovative trial designs in DMD," said Alexandre Bétourné, Pharm.D., Ph.D., Executive Director, RDCA-DAP.

Data from Brainomix's Collaboration with AstraZeneca Shows its AI-Powered e-Lung Better Identifies Lung Fibrosis Patients at Risk of Decline

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水曜日, 3月 27, 2024
AJRCCM, Medical research, ILD, AstraZeneca, ATS, Survival, Data science, Critical Care Medicine (journal), Partnership, Risk, Boehringer Ingelheim, Royal Brompton Hospital, Patient, American Journal, Lung, WRVS, Biopharmaceutical, Biomarker, Vital capacity, American Thoracic Society, Idiopathic pulmonary fibrosis, IPF, Clinical trial, Tralokinumab, Idiopathic disease, FVC

The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).

Key Points: 
  • The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).
  • The patient data from the trial was processed with Brainomix's e-Lung tool.
  • The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
  • WRVS was also able to predict both short- and long-term outcomes of the patients, including lung function decline and survival.

Data from Brainomix's Collaboration with AstraZeneca Shows its AI-Powered e-Lung Better Identifies Lung Fibrosis Patients at Risk of Decline

Retrieved on: 
水曜日, 3月 27, 2024
AJRCCM, Medical research, ILD, AstraZeneca, ATS, Survival, Data science, Critical Care Medicine (journal), Partnership, Risk, Boehringer Ingelheim, Royal Brompton Hospital, Patient, American Journal, Lung, WRVS, Biopharmaceutical, Biomarker, Vital capacity, American Thoracic Society, Idiopathic pulmonary fibrosis, IPF, Clinical trial, Tralokinumab, Idiopathic disease, FVC

The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).

Key Points: 
  • The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).
  • The patient data from the trial was processed with Brainomix's e-Lung tool.
  • The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
  • WRVS was also able to predict both short- and long-term outcomes of the patients, including lung function decline and survival.

NS Pharma, Inc. Shares New VILTEPSO® (Viltolarsen) Data at the MDA Clinical & Scientific Conference 2024

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水曜日, 3月 6, 2024
Duchenne, Research, MD, Duchenne muscular dystrophy, Trial of the century, Vital capacity, Conference, Annual general meeting, AAN, Muscular Dystrophy Association, Patient, FVC, Poster, MDA, Episcopal conference, American Academy, Pharmaceutical industry

PARAMUS, N.J., March 6, 2024 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma) is excited to announce participation in the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida, March 3 – 6. The company presented a poster entitled "Pulmonary and motor function in ambulatory and non-ambulatory participants with Duchenne muscular dystrophy (Duchenne) treated with viltolarsen (VILTEPSO®)" which covers data from the Galactic53 trial demonstrating that the majority of participants receiving viltolarsen experienced meaningful benefit in pulmonary function, including percent predicted forced vital capacity (FVC%p).

Key Points: 
  • PARAMUS, N.J., March 6, 2024 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma) is excited to announce participation in the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida, March 3 – 6.
  • "Galactic53 is the first trial with VILTEPSO to evaluate pulmonary function in participants with Duchenne," explains NS Pharma Vice President Medical Affairs & Pharmacovigilance Leslie Magnus, MD, who also co-authored the poster.
  • "Our team is encouraged by these results and will continue our research into treatments for rare disease."
  • Additional data from this study will also be presented at the American Academy of Neurology (AAN) 2024 Annual Meeting, April 13 – 18 in Denver, Colorado and online.

Cytokinetics Presents Results From COURAGE-ALS at the 34th International Symposium on ALS/MND

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木曜日, 12月 7, 2023
Patient, Research and development, HHD, Caregiver, Hope, Weakness, Disease, Incidence, Muscle weakness, SAN, Edaravone, Clinical trial, University, Barrow Neurological Institute, FVC, COVID-19, Death, Data monitoring committee, Infection, Weather, Transport, Riluzole, Vital capacity, General Grievous, Cytokinetics, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the full results of COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), were presented at the 34th International Symposium on ALS/MND by Jeremy Shefner, M.D., Ph.D., Lead Investigator of COURAGE-ALS, Professor of Neurology, Barrow Neurological Institute, University of Arizona College of Medicine Phoenix.

Key Points: 
  • At the second interim analysis the Data Monitoring Committee recommended the discontinuation of the clinical trial due to futility.
  • At the time of the discontinuation of COURAGE-ALS, 486 patients had started treatment with reldesemtiv or placebo and 276 had completed dosing through 24 weeks.
  • Patients treated with reldesemtiv declined 5.3 points per month (SD=5.3) while patients treated with placebo declined 4.8 points per month (SD=4.4).
  • The survey results showed that site personnel viewed remote visits favorably when considering whether to participate as a site in COURAGE-ALS.

Avalyn Presents Data from its AP01 and AP02 Inhaled Therapeutics Programs for Pulmonary Fibrosis

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木曜日, 11月 9, 2023
Lazarus, Pulmonary fibrosis, Lake, HRCT, Idiopathic pulmonary fibrosis, IPF, FVC, Summit, OLE, Disease, Caregiver, ATLAS, ILD, Vital capacity, Safety, Patient, PFF, FCCP, Outline, Pharmaceutical industry

SEATTLE, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted inhalation therapies for life-threatening pulmonary diseases, today announced the presentation of preclinical data that supported the completed Phase 1a trial of AP02 (inhaled nintedanib) as well as clinical data for AP01 (inhaled pirfenidone) at the 2023 Pulmonary Fibrosis Foundation (PFF) Summit at the JW Marriott Grande Lakes in Orlando, FL.

Key Points: 
  • “We are excited to engage with the pulmonary fibrosis community at the PFF Summit, including people living with the disease, their caregivers and the expert providers that support them, and to share data for our inhaled treatment candidates AP01 and AP02,” said Howard M. Lazarus, M.D.
  • These data demonstrated that inhaled nintedanib was well-tolerated, was indicative of efficient inhaled alveolar deposition, and delivered oral-superior lung levels with reduced systemic exposure.
  • Avalyn will also review the results from the Phase 1b trial of AP01 (ATLAS) in participants with idiopathic pulmonary fibrosis (IPF).
  • The OLE enrolled ATLAS participants and AP01-naïve pulmonary fibrosis participants, and the data showed a durable and consistent response to AP01, including fewer reported adverse events compared to historical reports of oral pirfenidone.