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  • ||||||||||  Bavencio (avelumab) / EMD Serono, GEN-001 / Genome & Company
    Phase II study of GEN-001 in combination with avelumab in patients with PD-L1 (Poster Bd # H10) -  Dec 6, 2023 - Abstract #ASCOGI2024ASCO_GI_251;    
    P2
    The results from this trial will be updated about its effects on clinical outcome, including survival, safety, and biomarker findings. Clinical trial information: NCT05419362.
  • ||||||||||  Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
    Phase classification:  Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers (clinicaltrials.gov) -  Nov 13, 2023   
    P1/2,  N=24, Recruiting, 
    These findings highlight the potential of Sh2 as an SCI therapeutic intervention, offering hope for neural and functional restoration in individuals with this debilitating condition. Phase classification: P2 --> P1/2
  • ||||||||||  Basalin (insulin glargine biosimilar) / Gan & Lee Pharma, LG Chem, Sandoz, Prandilin (insulin lispro biosimilar) / Gan & Lee Pharma, Sandoz, Rapilin (Gan & Lee Insulin Aspart biosimilar) / Gan & Lee Pharma, Sandoz
    Clinical, PK/PD data, Journal:  Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin (Pubmed Central) -  Nov 13, 2023   
    Phase classification: P2 --> P1/2 GL-Asp, GL-Lis and GL-Gla are bioequivalent to their EU- and US-reference products.
  • ||||||||||  MIT-001 / MitoImmune Therap
    Evaluation of the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_2667;    
    MIT-001 was administered intravenously for 30 minutes once daily before conditioning chemotherapy for four to nine days, depending on the conditioning regimens including high-dose melphalan and BMT (intravenous busulfan, melphalan, thiotepa) for auto-HSCT. The phase IIa part 1 results strongly suggest the therapeutic potential of MIT-001 to prevent severe OM in the patients with lymphoma and MM undergoing melphalan-containing conditioning followed by auto-HSCT.
  • ||||||||||  GEN-001 / Genome & Company
    Enrollment closed, Combination therapy, Metastases:  GEN001-201: GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer (clinicaltrials.gov) -  Oct 17, 2023   
    P2,  N=42, Active, not recruiting, 
    The phase IIa part 1 results strongly suggest the therapeutic potential of MIT-001 to prevent severe OM in the patients with lymphoma and MM undergoing melphalan-containing conditioning followed by auto-HSCT. Recruiting --> Active, not recruiting
  • ||||||||||  CUE-101 / Cue Biopharma, LG Chem
    Enrollment closed, Trial primary completion date, Combination therapy, Monotherapy, Metastases:  A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) -  Sep 21, 2023   
    P1,  N=85, Active, not recruiting, 
    To confirm these findings, further research is needed, including large RCTs. Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2023 --> Sep 2023
  • ||||||||||  Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem, Tecentriq (atezolizumab) / Roche
    Trial completion date:  IMMCO-1: Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types (clinicaltrials.gov) -  Sep 13, 2023   
    P1/2,  N=29, Recruiting, 
    Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2023 --> Sep 2023 Trial completion date: Dec 2024 --> Jun 2024
  • ||||||||||  Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
    Journal:  Comparative docking analysis of tyrosine kinase inhibitors with HER2 and HER4 receptors. (Pubmed Central) -  Sep 1, 2023   
    Lapatinib is identified as a potential inhibitor for both the RTKs. Our study thus suggests the probable direction that could be further explored in inhibiting EGFR protein harboring breast cancer.
  • ||||||||||  Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
    Enrollment open, Phase classification:  Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers (clinicaltrials.gov) -  Aug 28, 2023   
    P2,  N=30, Recruiting, 
    Our study thus suggests the probable direction that could be further explored in inhibiting EGFR protein harboring breast cancer. Suspended --> Recruiting | Phase classification: P1/2 --> P2
  • ||||||||||  MIT-001 / MitoImmune Therap
    Journal:  Alleviation of hippocampal necroptosis and neuroinflammation by NecroX-7 treatment after acute seizures. (Pubmed Central) -  Aug 21, 2023   
    Thus, we investigated the therapeutic effects of a novel small molecule, NecroX-7, in TLE using both a low [Mg]-induced epileptiform activity model and a mouse model of pilocarpine-induced status epilepticus (SE)...Finally, western blot analysis demonstrated that NecroX-7 post-treatment after acute seizures could decrease the expression of mixed lineage kinase domain-like pseudokinase (MLKL) and phosphorylated MLKL (p-MLKL), markers for necroptosis. Taken all together, NecroX-7 has potential as a novel medication for TLE with its neuroprotective, anti-inflammatory, and anti-necroptotic effects.
  • ||||||||||  GEN-001 / Genome & Company
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  GEN001-201: GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer (clinicaltrials.gov) -  Aug 8, 2023   
    P2,  N=42, Recruiting, 
    The investigational DTwP-HepB-Hib vaccine formulation was immunogenic and well-tolerated when administered as three dose primary series in infants. Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2024 --> Dec 2024
  • ||||||||||  Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
    Enrollment change, Trial termination, Combination therapy, Metastases:  DEDUCTIVE: A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) -  Jul 12, 2023   
    P1b/2,  N=27, Terminated, 
    Its tolerability positions tivozanib as an attractive first-line option for those unsuitable for combination therapies or unable to tolerate other TKIs. N=42 --> 27 | Active, not recruiting --> Terminated; The study was terminated due to regulatory approval of newer therapeutic options and slower than anticipated accrual.
  • ||||||||||  Lantus (insulin glargine) / Sanofi, Basalin (insulin glargine biosimilar) / Gan & Lee Pharma, LG Chem, Novartis
    Efficacy, safety, and immunogenicity of proposed biosimilar Gan & Lee insulin glargine versus EU-licensed insulin glargine in patients with type 1 diabetes (Short Oral Event F) -  Jul 2, 2023 - Abstract #EASD2023EASD_1308;    
    P3
    Supported By Gan & Lee Pharmaceuticals Clinical Trial Registration Number NCT03371082 Background and aims: To assess the bioequivalence (BE) of efficacy, safety, and immunogenicity profiles of GL Glargine Injection, a proposed biosimilar of insulin glargine, with EU-licensed insulin glargine (EU Lantus) in patients with type 1 diabetes mellitus (T1DM)... This study provides evidence of efficacy, safety, and immunogenicity BE of GL Glargine Injection to EU-licensed insulin glargine formulations in patients with T1DM.
  • ||||||||||  AV-380 / LG Chem
    Trial completion:  A Phase 1 Study of AV-380 in Healthy Subjects (clinicaltrials.gov) -  Jun 12, 2023   
    P1,  N=51, Completed, 
    Compared with untreated patients, TAF or BSV users showed similar risk, whereas ETV users showed a higher risk of renal function decline. Active, not recruiting --> Completed