pamrevlumab (FG-3019) / FibroGen 
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  • ||||||||||  BI 1015550 / Boehringer Ingelheim, pamrevlumab (FG-3019) / FibroGen
    Clinical, Review, Journal:  An update on emerging drugs for the treatment of idiopathic pulmonary fibrosis: a look towards 2023 and beyond. (Pubmed Central) -  Nov 13, 2023   
    Currently approved drug treatments for idiopathic pulmonary fibrosis (IPF), pirfenidone and nintedanib, have been shown to slow lung function decline and improve clinical outcomes...Particular attention is paid to the new inhibitor of phosphodiesterase 4B (BI 1015550), being studied in a more advanced research phase...An exponential number of randomized clinical trials are underway testing promising new molecules to increase treatment choices for patients with IPF and improve patients' quality of life. The next goals should aim at a deeper understanding of the pathogenic pathways of the disease with the challenging goal of being able not only to stabilize but also to reverse the ongoing fibrotic process in patients with IPF.
  • ||||||||||  pamrevlumab (FG-3019) / FibroGen
    Trial completion date, Trial termination, Trial primary completion date:  FGCL-3019-095: Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) -  Nov 3, 2023   
    P3,  N=372, Terminated, 
    The next goals should aim at a deeper understanding of the pathogenic pathways of the disease with the challenging goal of being able not only to stabilize but also to reverse the ongoing fibrotic process in patients with IPF. Trial completion date: Apr 2025 --> Sep 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2024 --> Sep 2023; Sponsor Decision
  • ||||||||||  pamrevlumab (FG-3019) / FibroGen
    Review, Journal:  An up-to-date review of approved and emerging antibody therapies for idiopathic pulmonary fibrosis. (Pubmed Central) -  Oct 5, 2023   
    The use of pirfenidone and nintedanib in treating Idiopathic Pulmonary Fibrosis (IPF) has shown significant slowing down of the progressive functional decline in these patients...Currently, the anti-CTGF pamrevlumab has demonstrated a significant reduction in functional decline as compared to placebo and is undergoing the last stages of phase 3 trial...However, several molecules are still under study and some have shown encouraging results in the early phases of clinical trials. Future investigations need to be more carefully designed and valid predictive markers of response to treatment should be used to enhance the effectiveness of future trials.
  • ||||||||||  pamrevlumab (FG-3019) / FibroGen
    Journal:  Blocking CCN2 Reduces Established Palmar Neuromuscular Fibrosis and Improves Function Following Repetitive Overuse Injury. (Pubmed Central) -  Oct 2, 2023   
    Grip strength declines correlated with muscle fibrosis, entheseal damage, extraneural fibrosis, and decreased nerve conduction velocity, while enhanced mechanical sensitivity (a pain-related behavior) correlated with extraneural fibrosis. These studies demonstrate that blocking CCN2 signaling reduces established forepaw neuromuscular fibrosis and entheseal damage, which improves forepaw function, following overuse injury.
  • ||||||||||  pamrevlumab (FG-3019) / FibroGen
    Preclinical, Journal:  Blocking CCN2 Reduces Established Bone Loss Induced by Prolonged Intense Loading by Increasing Osteoblast Activity in Rats. (Pubmed Central) -  Sep 13, 2023   
    Blocking either YAP1 or CCN2 might be a novel approach for the treatment of APS-associated micro-vasculopathies. Two other cohorts were placed on 6?weeks of rest while being simultaneously treated with either an anti-CCN2 (FG-3019, 40?mg/kg body weight, ip; twice per week; HRHF-Rest/anti-CCN2), or a control IgG (HRHF-Rest/IgG), with the purpose of determining which might improve the trabecular bone decline..
  • ||||||||||  Trial completion date, Trial primary completion date, Metastases:  A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer (clinicaltrials.gov) -  Jul 28, 2023   
    P3,  N=825, Active, not recruiting, 
    Two other cohorts were placed on 6?weeks of rest while being simultaneously treated with either an anti-CCN2 (FG-3019, 40?mg/kg body weight, ip; twice per week; HRHF-Rest/anti-CCN2), or a control IgG (HRHF-Rest/IgG), with the purpose of determining which might improve the trabecular bone decline.. Trial completion date: May 2026 --> Jun 2027 | Trial primary completion date: May 2024 --> Jun 2027
  • ||||||||||  Enrollment closed, Metastases:  A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer (clinicaltrials.gov) -  Mar 21, 2023   
    P3,  N=825, Active, not recruiting, 
    Excellent properties for inhaled lung delivery make PRS-220 a promising treatment option for IPF and support currently ongoing clinical development (NCT05473533). Recruiting --> Active, not recruiting
  • ||||||||||  pamrevlumab (FG-3019) / FibroGen
    Enrollment closed, Trial completion date, Trial primary completion date:  Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) -  Nov 15, 2022   
    P3,  N=356, Active, not recruiting, 
    Future guidelines should consider sildenafil for IPF and further research needs to be done on promising IPF treatments such as pamrevlumab and pentraxin as phase 3 trials are completed. Recruiting --> Active, not recruiting | Trial completion date: Jan 2023 --> Jun 2024 | Trial primary completion date: Dec 2022 --> Mar 2023
  • ||||||||||  pamrevlumab (FG-3019) / FibroGen
    Review, Journal:  CTGF as a multifunctional molecule for cartilage and a potential drug for osteoarthritis. (Pubmed Central) -  Nov 4, 2022   
    Pamrevlumab, a monoclonal antibody against CTGF, is an FDA approved drug for idiopathic pulmonary fibrosis (IPF) and Duchenne muscular dystrophy (DMD)...Changes in the related signaling pathways due to abnormal CTGF are discussed, which are contributing factors to inflammation, cartilage degeneration and synovial fibrosis in OA. The possibility of CTGF as a potential therapeutic target for OA treatment are reviewed.
  • ||||||||||  Trial completion date, Trial primary completion date, Metastases:  A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer (clinicaltrials.gov) -  Jun 1, 2022   
    P3,  N=825, Recruiting, 
    No new safety signals emerged. Trial completion date: Feb 2024 --> May 2026 | Trial primary completion date: Jan 2024 --> May 2024
  • ||||||||||  pamrevlumab (FG-3019) / FibroGen, racemetyrosine (SM-88) / Tyme
    Precision Promise (PrP): An adaptive, multi-arm registration trial in metastatic pancreatic ductal adenocarcinoma (PDAC). (Available On Demand; 159a) -  Apr 28, 2022 - Abstract #ASCO2022ASCO_2023;    
    P3
    Focused on 1st and 2nd line treatment of mPDAC, PrP uses an adaptive platform design with randomization to one of 2 control arms (gemcitabine + nab-paclitaxel (GA) or mFOLFIRINOX, 30% of pts) or experimental therapy (70% of pts)...Current experimental arms include: (i) GA + Pamrevlumab, an anti-CTGF Ab, (ii) Racemetyrosine monotherapy, a cancer metabolism-based therapy (for follow-up of patients) and (iii) an immuno-oncology arm in activation...Compared to traditional designs, PrP offers several advantages: multiple investigational treatments evaluated in parallel over time; ̃175 pts per experimental arm required to initiate a regulatory registration; and continuous learning from every patient, resulting in significant savings of time and resources. PrP has created an entirely new learning environment for accelerating drug development in PDAC.
  • ||||||||||  nintedanib / Generic mfg.
    Review, Journal:  Molecular pathways and role of epigenetics in the idiopathic pulmonary fibrosis. (Pubmed Central) -  Feb 19, 2022   
    Newer drugs such as Celgene-CC90001 and FibroGen-FG-3019 are currently under investigations acts through the modulating epigenetic mechanisms...This study provides an elementary analysis of multiple regulators of epigenetics and their roles associated with the pathology of IPF. Further, this review also includes epigenetic drugs under development in preclinical and clinical stages.
  • ||||||||||  PRS-220 / Pieris Pharmaceuticals
    PRS-220, a Novel Inhalable Therapeutic Intervention for IPF, Targeting CTGF Directly in the Lung (Room 2022/2024 (West Building, Level 2), Moscone Center) -  Feb 19, 2022 - Abstract #ATS2022ATS_5794;    
    PRS-220 binds with a picomolar affinity to CTGF and shares an overlapping epitope with the clinical-stage, CTGF-targeting antibody pamrevlumab, while demonstrating superior potency compared to the antibody. The promising preclinical profile supports proceeding the development of PRS-220 as a novel, potential best-in-class, inhaled antagonist of CTGF for the treatment of IPF.
  • ||||||||||  pamrevlumab (FG-3019) / FibroGen
    Journal:  Driving fibrosis in neuromuscular diseases: Role and regulation of Connective tissue growth factor (CCN2/CTGF). (Pubmed Central) -  Aug 27, 2021   
    Reducing CCN2/CTGF levels or biological activity in pathological conditions can decrease fibrosis, improve muscle architecture and function. In this work, we summarize information about the role of CCN2/CTGF in fibrosis associated with neuromuscular pathologies and the mechanisms and signaling pathways that regulate their expression in skeletal muscle.
  • ||||||||||  nintedanib / Generic mfg.
    [VIRTUAL] Simultaneous inhibition of CTGF and Autotaxin reduces lung fibrosis and improves lung function in mice () -  Jul 29, 2021 - Abstract #ERS2021ERS_2212;    
    Mice were subjected to intratracheal dosing of bleomycin to induce lung fibrosis and treated with FG3019 and/or GLPG1690 for 14 days...The Ashcroft-Hubner scores were reduced in mice receiving FG3019 or GLPG1690 as a single treatment, but further reductions were not observed mice treated with FG3019 and GLPG1690. The combination of FG3019 and GLPG1690 treatment demonstrated an enhanced therapeutic efficacy by conferring the independent and parallel benefits of the single agents on experimental lung fibrosis endpoints.
  • ||||||||||  pamrevlumab (FG-3019) / FibroGen
    Review, Journal:  A centralized communication network: Recent insights into the role of the cancer associated fibroblast in the development of drug resistance in tumors. (Pubmed Central) -  Feb 24, 2021   
    Drugs targeting the matricellular protein CCN2 (centralized communication network 2, formerly termed connective tissue growth factor), are in clinical development for cancers; for example, FG-3019, an antibody targeting CCN2 has recently entered Phase III trials for pancreatic cancer...In clinical melanoma samples, a FAP/ITGA11/COL1A1/CCN2-expressing CAF population negatively correlates with disease-free survival. These data emphasize the essential role for a CCN2-expressing subset of CAFs in cancer progression and suggest that targeting the CAFs in the tumor microenvironment, for example by blocking the action of CCN2, may be useful in combination therapies to treat cancers.
  • ||||||||||  pamrevlumab (FG-3019) / FibroGen
    Journal:  Pamrevlumab for the treatment of idiopathic pulmonary fibrosis. (Pubmed Central) -  Feb 3, 2021   
    This agent has the potential to become an alternative therapeutic option for IPF; however, the feasibility of intravenous administration in clinical practice may be a hurdle to its use as a first-line treatment. Further studies are necessary to assess its effects when administered with pirfenidone or nintedanib and this could open up a new era of combined therapeutic approaches for IPF.
  • ||||||||||  pamrevlumab (FG-3019) / FibroGen
    Preclinical, Journal:  Blocking CTGF/CCN2 reverses neural fibrosis and sensorimotor declines in a rat model of overuse-induced median mononeuropathy. (Pubmed Central) -  Feb 2, 2021   
    FG-3019 treated rats showed no increase above control levels of perineural collagen or degraded myelin basic protein in median nerves, Substance P in lower cervical DRGs, or ATF3-immunopositive nuclei in ventral horns, and similar median nerve conduction velocities and thermal sensitivity, compared to controls. We hypothesize that neural fibrotic processes underpin the sensorimotor declines by compressing or impeding median nerves during movement, and that inhibiting fibrosis using an anti-CCN2 treatment reverses these effects.