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  • ||||||||||  Hyruan Plus (sodium hyaluronate) / LG Chem
    Clinical, Journal:  Effects and Safety of Intra-Articular Sodium Hyaluronate Injection for the Treatment of Ankle Osteoarthritis: A Prospective Clinical Trial. (Pubmed Central) -  Mar 16, 2022   
    3 weekly hyaluronate injections (2 mL Hyruan Plus®) were administered...This study suggests that 3 weekly intra-articular hyaluronate injections can be performed safely to reduce pain and improve function without serious complications in patients with early or intermediate-grade ankle osteoarthritis when patients inadequately respond to medication. Larger controlled studies are needed to clarify the effects of hyaluronate injection and identify patients who can benefit most from hyaluronate injection.
  • ||||||||||  ZemiSU (gemigliptin/glimepiride) / LG Chem, Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca, Gemiglo (gemigliptin) / Sanofi, LG Chem
    Retrospective data, Journal:  Efficacy and Safety of the Novel Dipeptidyl Peptidase-4 Inhibitor Gemigliptin in the Management of Type 2 Diabetes: A Meta-Analysis. (Pubmed Central) -  Mar 15, 2022   
    Four had an active control group (ACG), with metformin/dapagliflozin/sitagliptin/glimepiride as the active comparator; six had a passive control group (PCG), with placebo/rosuvastatin as controls...The gemigliptin group did not have increased hypoglycaemia (RR, 1.19; 95% CI, 0.62 to 2.28; P=0.61; I2=19%; HCE). Gemigliptin has good glycaemic efficacy and is well-tolerated over 6 months of use.
  • ||||||||||  mocetinostat (MGCD0103) / Mirati, Otsuka, Fotivda (tivozanib) / Kyowa Kirin, AVEO, Jazz, Tazverik (tazemetostat) / Epizyme, Eisai
    Systematic identification of the chemo-immunotherapy synergism to overcome immunotherapy resistance in cancer (E-Poster Website) -  Mar 9, 2022 - Abstract #AACR2022AACR_7117;    
    In a triple negative breast cancer patient cohort who received the combination of anti-PDL1 and paclitaxel, POSEIDON also predicted several HDAC inhibitors (e.g., mocetinostat) and thymidylate synthase inhibitors (e.g., trifluridine) to synergize with the combination of anti-PDL1 plus paclitaxel and reverse the combination resistance through activating the immune response in tumor microenvironment...The synergy between EZH2 inhibitor and anti-PD1 was further validated in vivo by treating the anti-PD1 resistant 4T1.2 mouse model with FDA approved EZH2 inhibitor tazemetostat and PD1 antibody...Collectively, our study demonstrated that POSEIDON can provide reliable prediction of chemo-immunotherapy synergism by integrating the post-treatment transcriptomic profiles from patient tumor microenvironment and cell lines. We envision that the systematic identification of chemo-immunotherapy synergism will help cancer patients to cope with immunotherapy resistance in the short future.
  • ||||||||||  Avastin (bevacizumab) / Roche, IACS-010759 / UT MD Anderson Cancer Center, Fotivda (tivozanib) / Kyowa Kirin, AVEO, Jazz
    Angiogenesis inhibitors strongly synergize with therapeutics targeting tumor metabolism (Section 14) -  Mar 9, 2022 - Abstract #AACR2022AACR_5709;    
    The same results were recapitulated with the VEGFR inhibitor Tivozanib and HEX and the enolase inhibitor could be substituted with the Oxphos inhibitor IACS-010759, with similar effects...Together, these results suggest that angiogenesis inhibitors synergize broadly with cancer therapies targeting metabolism, allowing the realization of the full potential of these previously disappointing drugs. Our results warrant systematic combination clinical trials between angiogenesis inhibitors and established, as well as emerging anti-metabolic cancer therapies.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
    Cost Effectiveness of Cabozantinib Plus Nivolumab As First-Line Treatment for Renal Cell Carcinoma () -  Mar 8, 2022 - Abstract #ISPOR2022ISPOR_3;    
    P3
    Under a lifetime horizon (50-years), patients entered the model in the progression-free state and received 1L CaboNivo or an alternative tyrosine kinase inhibitor (TKI; cabozantinib, pazopanib, temsirolimus, tivozanib, sorafenib, sunitinib) or combination (axitinib/avelumab, axitinib/pembrolizumab, ipilimumab/nivolumab, lenvatinib/pembrolizumab)... CaboNivo had a favourable cost-effectiveness profile compared to other globally available 1L treatment options when using French costs over a lifetime horizon.
  • ||||||||||  ficlatuzumab (AV-299) / LG Chem, Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Trial completion date, Trial primary completion date, Metastases:  P30CA023074: Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma (clinicaltrials.gov) -  Mar 8, 2022   
    P2,  N=74, Active, not recruiting, 
    CaboNivo had a favourable cost-effectiveness profile compared to other globally available 1L treatment options when using French costs over a lifetime horizon. Trial completion date: Dec 2021 --> May 2022 | Trial primary completion date: Dec 2021 --> May 2022
  • ||||||||||  Besivo (besifovir) / Gilead, LG Chem, Ildong
    Journal:  Identification and Characterization of Besifovir-Resistant Hepatitis B Virus Isolated from a Chronic Hepatitis B Patient. (Pubmed Central) -  Feb 26, 2022   
    Besifovir dipivoxil maleate (BSV) is a newly developed NA against HBV in the form of acyclic nucleotide phosphonate that is available for oral administration similar to adefovir and tenofovir...To further identify the responsible mutations for BSV resistance, we performed in vitro drug susceptibility assay on several artificial clones. As a result, our study revealed that rtL180M (M) and rtM204V (V) mutations, already known as lamivudine-resistant mutations, confer resistance to BSV in the CHB patient.
  • ||||||||||  Besivo (besifovir) / Gilead, LG Chem, Ildong
    Long-term efficacy and safety of Besifovir in CHB (205AB, 2F) -  Feb 24, 2022 - Abstract #APASL2022APASL_530;    
    Developing and disseminating an AHP-specific educational deck, AHPs expressed increased confidence in their care of patients receiving FOTIVDA®. Sponsored by ILDONG Pharmaceutical Co., Ltd
  • ||||||||||  Besivo (besifovir) / Gilead, LG Chem, Ildong
    PK/PD data, Journal:  Influence of renal function on the single-dose pharmacokinetics of besifovir, a novel antiviral agent for the treatment of hepatitis B virus infection. (Pubmed Central) -  Feb 22, 2022   
    Per the well-known resistance of hepatitis B virus to nucleoside/nucleotide analogs, alternative treatment options with higher resistance barriers have been approved for use in both treatment-naïve and lamivudine-resistant hepatitis B virus infections...The ratios of LB80331 renal clearance and the average estimated glomerular filtration rate of each renal impairment group with respect to the normal group were similar. The increase in plasma exposure and decrease in renal clearance suggest the need to adjust dosage regimens in patients with moderate-to-severe renal impairment.
  • ||||||||||  Jardiance (empagliflozin) / Eli Lilly, Boehringer Ingelheim, Gemiglo (gemigliptin) / Sanofi, LG Chem
    Preclinical, Journal:  Hepatoprotective effects of gemigliptin and empagliflozin in a murine model of diet-induced non-alcoholic fatty liver disease. (Pubmed Central) -  Feb 9, 2022   
    Furthermore, in these three groups, the galectin-3 and interleukin 33-induced activity of tumor necrosis factor-α was inhibited, thereby preventing the progression of liver fibrosis. These findings suggest that the GEMI, EMPA, and GEMI + EMPA treatments ameliorate hepatic steatosis, inflammation, oxidative stress, and fibrosis in CDAHFD-induced NAFLD mouse models.
  • ||||||||||  ICM-203 / Yonsei Technology Holdings
    Trial completion date, Trial initiation date, Trial primary completion date:  A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis (clinicaltrials.gov) -  Jan 31, 2022   
    P1/2,  N=24, Not yet recruiting, 
    The innovative combination of fluvoxamine and tivozanib reiterates the use of drug repositioning for precision medicine and subsequent companion diagnostic development. Trial completion date: Jun 2023 --> Sep 2023 | Initiation date: Sep 2021 --> Feb 2022 | Trial primary completion date: Feb 2023 --> Jun 2023
  • ||||||||||  Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
    Enrollment open:  Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers (clinicaltrials.gov) -  Jan 26, 2022   
    P1/2,  N=30, Recruiting, 
    However, to confirm the results, more studies need to be analysed and the minimum clinically important difference must be applied. Not yet recruiting --> Recruiting
  • ||||||||||  Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, TNFcept (etanercept biosimilar) / LG Chem, Mochida, Enbrel (etanercept) / Pfizer, Amgen
    New P4 trial:  REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST) (clinicaltrials.gov) -  Dec 20, 2021   
    P4,  N=448, Not yet recruiting, 
  • ||||||||||  Fotivda (tivozanib) / Kyowa Kirin, AVEO, Jazz
    Clinical, Retrospective data, Journal:  Safety and Efficacy of Tivozanib in First-Line mRCC: A Multicenter Compassionate-Use Study (Meet-Uro 16). (Pubmed Central) -  Dec 16, 2021   
    Tivozanib showed good activity and favorable safety profile in a real-world cohort of unselected patients with mRCC. Predictive biomarkers of response to antiangiogenic therapy are urgently needed in order to identify RCC patients who could still receive a monotherapy with VEGFR inhibitors in the first line.
  • ||||||||||  AV-380 / LG Chem
    Enrollment closed:  A Phase 1 Study of AV-380 in Healthy Subjects (clinicaltrials.gov) -  Dec 6, 2021   
    P1,  N=56, Active, not recruiting, 
    Active, not recruiting --> Completed Recruiting --> Active, not recruiting
  • ||||||||||  MIT-001 / MitoImmune Therap
    Enrollment open, Trial completion date, Trial primary completion date, Metastases:  MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients (clinicaltrials.gov) -  Dec 2, 2021   
    P2,  N=60, Recruiting, 
    Enrollment is nearly complete with 19 of 20 patients in the front-line cohort enrolled; a second cohort of 20 patients who have progressed on prior bevacizumab and atezolizumab has been opened and is also enrolling. Not yet recruiting --> Recruiting | Trial completion date: Apr 2023 --> Sep 2023 | Trial primary completion date: May 2022 --> Sep 2022
  • ||||||||||  TNFcept (etanercept biosimilar) / LG Chem, Mochida
    Journal:  LBEC0101, an etanercept biosimilar for the treatment of rheumatoid arthritis. (Pubmed Central) -  Nov 29, 2021   
    An extension study showed that efficacy was sustained long-term in patients receiving LBEC0101 and in those switching from the ETN-RP to LBEC0101. The safety profile of LBEC0101 was also confirmed to be comparable with the ETN-RP.Expert Opinion: LBEC0101 has shown equivalent pharmacokinetics and efficacy and comparable safety to the ETN-RP, and the lower cost of LBEC0101 provides a good cost-benefit ratio.