- |||||||||| Shinbaro (GCSB-5) / Green Cross, LG Chem
Preclinical, Journal: Effects of SHINBARO2 on Rat Models of Lumbar Spinal Stenosis. (Pubmed Central) - Dec 20, 2019 In addition, brain-derived neurotrophic factor (BDNF), a potent promoter of neurite growth, and its downstream ERK signaling were also regulated by SHINBARO2. These findings suggest that the effect of SHINBARO2 might be associated in part with the anti-inflammation and pain control in LSS rat models.
- |||||||||| ficlatuzumab (AV-299) / AVEO, Biodesix, Abraxane (albumin-bound paclitaxel) / Otsuka, BMS, gemcitabine / Generic mfg.
Phase Ib study of gemcitabine, nab-paclitaxel, and ficlatuzumab in patients with advanced pancreatic cancer. (Level 1, West Hall - Poster Board K4) - Dec 10, 2019 - Abstract #ASCOGI2020ASCO-GI_647; P1b Serial blood samples were collected for circulating HGF measurements, and mandatory pretreatment biopsies were collected for tumor c-MET pathway activation and 3D organoid culture drug sensitivity testing. Clinical trial information: NCT03316599.
- |||||||||| tigulixostat (LC350189) / LG Chem
Enrollment open: Renal PK Study of LC350189 (clinicaltrials.gov) - Nov 27, 2019 P1, N=48, Recruiting, Clinical trial information: NCT03316599. Not yet recruiting --> Recruiting
- |||||||||| Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Journal: Targeting the c-MET/HGF signaling pathway in pancreatic ductal adenocarcinoma. (Pubmed Central) - Nov 23, 2019 It is likely that within the next few years, HGF/Met inhibitors will become a crucial component for cancer management. In this review, we summarize the role of HGF/Met pathway in the pathogenesis of pancreatic cancer, with particular emphasize on HGF/Met inhibitors in the clinical setting, including Cabozantinib (XL184, BMS-907351), Crizotinib (PF-02341066), MK-2461, Merestinib (LY2801653), Tivantinib (ARQ197), SU11274, Onartuzumab (MetMab), Emibetuzumab (LY2875358), Ficlatuzumab (AV-299), Rilotumumab (AMG 102), NK4 in pancreatic cancer.
- |||||||||| Clinical, Review, Clinical Trial,Phase I, Clinical Trial,Phase II, Journal: Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents. (Pubmed Central) - Nov 16, 2019
In conclusion, immunogenicity data of biosimilars or biosimilar candidates for TNFα or CD20 inhibitors were collected in trials that varied in design and procedures for ADAb/nAb detection. In general, immunogenicity parameters of biosimilars are similar to those of their reference products.
- |||||||||| Fotivda (tivozanib) / EUSA Pharma, AVEO
Dynamic regulation of macrophage subpopulations in mouse models of kidney injury (Exhibit Hall, Walter E. Washington Convention Center) - Oct 14, 2019 - Abstract #KIDNEYWEEK2019KIDNEY_WEEK_4220; Treatment with the VEGF receptor tyrosine kinase inhibitor tivozanib effectively reduced total numbers of MHCII-positive and CD11bhighCD11chigh macrophages after eight days of UUO...Being able to monitor and understand the dynamics of different macrophage subsets within diseased organs could help in finding new therapeutic angles. Funding Commercial Support
- |||||||||| Zemimet SR (gemigliptin/metformin sustained release) / LG Chem
Trial completion date, Trial primary completion date, Combination therapy: INTESTINE: Initial Combination of Gemigliptin and Metformin on Microbiota Change (clinicaltrials.gov) - Oct 8, 2019 P=N/A, N=70, Recruiting, Funding Commercial Support Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Apr 2019 --> Dec 2019
- |||||||||| Shinbaro (GCSB-5) / Green Cross, LG Chem
Clinical, Clinical guideline, Journal: Survey of Integrative Treatment Practices of Korean Medicine Doctors for Cervical Disc Herniation: Preliminary Data for Clinical Practice Guidelines. (Pubmed Central) - Sep 21, 2019 Shinbaro pharmacopuncture and Chungpa-jun, which are well-established herbal treatments supported by evidence, were considered to be of high importance in CDH treatment...This study is the first report to investigate current practice patterns and approach of Korean medicine doctors to CDH treatment. This data may be of significance to Korean medicine doctors in drawing clinical guidelines and conducting randomized controlled trials (RCTs) to generate high-level evidence on the effectiveness of nonsurgical integrative medicine treatments for CDH.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen, Yervoy (ipilimumab) / Ono Pharma, BMS
Review, Journal: Risk-adapted (immuno)therapy for renal cell carcinoma (Pubmed Central) - Sep 14, 2019 The importance of the checkpoint blockade in the first line is clinically undisputed; however, approval of the immune combination ipilimumab + nivolumab has not yet been granted. An important task now is to offer risk-adapted therapy in order to optimally balance efficacy and risks of systemic therapy, thereby ensuring the best possible individual therapy.
- |||||||||| Journal: Interdisciplinary recommendations for the treatment of metastatic renal cell carcinoma (Pubmed Central) - Sep 6, 2019
The use of both the combination Nivolumab + Ipilimumab and Cabozantinib is limited to intermediate and high-risk patients...Temsirolimus is only approved for high-risk patients...Furthermore, the combination of Lenvatinib + Everolimus and Axitinib are approved treatment options in second-line and further settings...As in previous years, the experts intended to provide recommendations for clinical practice. The results are presented here.
- |||||||||| tigulixostat (LC350189) / LG Chem
New P1 trial: Renal PK Study of LC350189 (clinicaltrials.gov) - Aug 26, 2019 P1, N=48, Not yet recruiting,
- |||||||||| ZemiStatin (gemigliptin/rosuvastatin FDC) / LG Chem
Clinical, P3 data, Journal, Combination therapy, Monotherapy: Efficacy and safety of fixed-dose comBination therApy with gemigLiptin (50 mg) and rosuvAstatiN (20 mg) Compared with Each monotherapy in patients with type 2 diabetes and dyslipidaemia (BALANCE): A multicentre, randomized, double-blind, controlled, phase 3 trial. (Pubmed Central) - Aug 21, 2019 Febrile HIV late presenters should be suspected for "the septic form" of MAC disease; blood, urine and feces being obligatory tested by MGM/CL The FDC of gemigliptin/rosuvastatin is effective and safe at reducing both blood glucose and LDL-C levels and could be a good therapeutic choice for type 2 diabetic patients with dyslipidaemia.
- |||||||||| ficlatuzumab (AV-299) / LG Chem
Enrollment closed: Ficlatuzumab With High Dose Cytarabine in Relapsed and Refractory AML (clinicaltrials.gov) - Aug 20, 2019 P1, N=17, Active, not recruiting, The FDC of gemigliptin/rosuvastatin is effective and safe at reducing both blood glucose and LDL-C levels and could be a good therapeutic choice for type 2 diabetic patients with dyslipidaemia. Recruiting --> Active, not recruiting
- |||||||||| Journal: Immunotherapy for renal cell carcinoma - current status (Pubmed Central) - Aug 8, 2019
Nivolumab in combination with Ipilimumab will become a standard 1st line option for patients with intermediate and high risk profile according to IMDC. Further data are required regarding PD-1/PD-L1 inhibitors in combination with Bevacizumab and VEGFR-TKIs, respectively, including overall survival and side effect profile.
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