Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of ORTHIX PLUS for Pain Relief in Patients Suffering From Osteoarthritis or Degenerative Joint Diseases

This trial is a post marketing clinical follow up study, aiming to evaluate the performance and safety of ORTHIX PLUS for pain relief in patients suffering from osteoarthritis or degenerative joint diseases.
The study will involve 54 subjects, who will be enrolled in 2 centers in Turkey. The primary objective is to evaluate the overall performance of ORTHIX PLUS in providing relief in patients suffering from painful knee ostearthritis or degenerative joint diseases when used according to indications for use.
The first secondary objective is to evaluate the overall performance of ORTHIX PLUS in providing relief when used according to indications for use, at different time points. The other secondary objective is to evaluate the overall safety during the study period.

Start Date01 Jul 2022

Sponsor / Collaborator

Yooyoung Pharm Co. Ltd.

[+1]

NCT05229458 / Unknown statusNot Applicable

Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of HYALEXO for Pain Relief in Patients Suffering From Osteoarthritis or Degenerative Joint Diseases

This trial is a post marketing clinical follow up study, aiming to evaluate the performance and safety of Hyalexo for pain relief in patients suffering from osteoarthritis or degenerative joint diseases.
The study will involve 54 subjects, who will be enrolled in 4 centers in France. The performance outcomes will be evaluated by the koos score, and VAS for pain, while the safety outcomes will be assessed by a safety checklist and by collecting all the adverse events (Adverse Event/Adverse Device Effect/Serious Adverse Event/Serious Adverse Device Effect/Unanticipated Serious Adverse Device Effect/Device Deficiencies) at all visits.

Start Date01 May 2022

Sponsor / Collaborator

Yooyoung Pharm Co. Ltd.

[+1]

NCT05362851 / Unknown statusPhase 3

a Multicenter, Double-blind, Randomized, Active Drug Control, Parallel Design Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of YYC301 in Patients With Osteoarthritis of the Knee Joint

A Multi-center, Double-blinded, Randomized, Active-controlled, Parallel Design, phase 3 Clinical Trial to Evaluate the Efficacy and Safety of YYC301 in Patients with Osteoarthritis of the Knee Joint

Start Date11 Nov 2021

Sponsor / Collaborator

Yooyoung Pharm Co. Ltd.

100 Clinical Results associated with Yooyoung Pharm Co. Ltd.

0 Patents (Medical) associated with Yooyoung Pharm Co. Ltd.

Literatures (Medical) associated with Yooyoung Pharm Co. Ltd.

20 May 2019·Journal of Clinical Oncology

First-in-human phase I trial of anti-hepatocyte growth factor (HGF) antibody (YYB101) in refractory solid tumor patients: Integrative pathologic-genomic analysis and the final results.

Author: Lee, Hukeun ; Park, Neunggyu ; Park, Young Suk ; Lim, Ho Yeong ; Kim, Jung Ju ; Kang, Won Ki ; Lee, Su Jin ; Lee, Jeeyun ; Lee, Song-Jae ; Kim, Hoon-Kyo ; Park, Joon Oh ; Nam, Do-Hyun ; Kim, Seung ; Song, Seong-Won ; Kim, Kyoung-Mee ; Lee, Jeong-Won ; Park, Se Hoon

3104 Background: It has been demonstrated in vivo that HGF-MET signaling axis is a key molecular determinant in tumor invasion and there is a significant association in HGF expression and mesenchymal phenotype in addition to immune cell recruitment. We have developed a HGF neutralizing humanized monoclonal antibody antibody, YYB-101. The aim of this study was to determine the maximum tolerate dose (MTD), safety, pharmacokinetics (PK), and pharmacodynamics (PD) of YYB101, in patients with refractory solid tumors. Methods: YYB101 was administered intravenously at once every 2 weeks doses of 0.3, 1, 3, 5, 10, 20, 30 mg/kg, according to a 3+3 dose escalation design. Enrolled patients were planned to receive YYB101 until disease progression or intolerable toxicity. The escalation and expansion cohorts (20mg/kg) were completed. Pre-planned biomarker analysis was performed in parallel. Results: 39 heavily pre-treated refractory cancer patients were enrolled and received YYB101. No DLT was observed. YYB101 demonstrated dose proportional PK up to the dose of 30 mg/kg. No patients discontinued treatment because of adverse events. Based on PK analysis and toxicity data, the recommended dose was determined as 20 mg/kg. Of 39 evaluation patients, there was 1 confirmed partial response for > +14months (2.5%, N = 1; 1 (of 2) sebaceous carcinoma) and 17 stable disease as best response (43.5%, N = 17; 7 (of 13) CRC, 3 (of 4) melanoma, 1 (of 2) sebaceous carcinoma, 1 (of 3) gastric, 1 (of 1) basal cell carcinoma, 2 (of 10) ovarian cancer, 1 (of 1) HCC, 1 (of 1) lung cancer). Of note, 1 sebaceous carcinoma patient who have failed to ≥2+ lines of chemotherapy, have been responding to YYB for 14 months. The MET and HGF expressions by immunohistochemistry (IHC) were evaluated in 19 and 17 tumor specimens, respectively. Neither protein expressions were significant predictors for treatment response to anti-HGF antibody. However, we have observed significant reduction in HGF in responders to YYB. Two long-term responders had mesenchymal signature in RNA sequencing. Conclusions: YYB101 has a favorable safety profile in patients with refractory solid tumors and a dose-proportional PK. Efficacy data are encouraging and phase II combination therapy with YYB101 is planned to be open in metastatic CRC patients as salvage treatment. The predictive power of mesenchymal signature in YYB responders will be defined prospectively. Clinical trial information: 02499224.

14 Feb 2019·Neuro-OncologyQ1 · MEDICINE

Identification of genomic and molecular traits that present therapeutic vulnerability to HGF-targeted therapy in glioblastoma

Q1 · MEDICINE

Article

Author: Sa, Jason K ; Song, Seong-Won ; Joo, Kyeung Min ; Shin, Hyemi ; Lee, Mijeong ; Nam, Do-Hyun ; Hong, Sung Hee ; Koo, Harim ; Park, Young-Whan ; Cho, Hee Jin ; Lee, Jin-Ku ; Lee, Song-Jae ; Kim, Donggeon ; Kim, Jung Yong ; Kim, Sung Heon ; Shin, Yong Jae ; Kang, Wonyoung

BACKGROUNDCancer is a complex disease with profound genomic alterations and extensive heterogeneity. Recent studies on large-scale genomics have shed light on the impact of core oncogenic pathways, which are frequently dysregulated in a wide spectrum of cancer types. Aberrant activation of the hepatocyte growth factor (HGF) signaling axis has been associated with promoting various oncogenic programs during tumor initiation, progression, and treatment resistance. As a result, HGF-targeted therapy has emerged as an attractive therapeutic approach. However, recent clinical trials involving HGF-targeted therapies have demonstrated rather disappointing results. Thus, an alternative, in-depth assessment of new patient stratification is necessary to shift the current clinical course.METHODSTo address such challenges, we have evaluated the therapeutic efficacy of YYB-101, an HGF-neutralizing antibody, in a series of primary glioblastoma stem cells (GSCs) both in vitro and in vivo. Furthermore, we performed genome and transcriptome analysis to determine genetic and molecular traits that exhibit therapeutic susceptibility to HGF-mediated therapy.RESULTSWe have identified several differentially expressed genes, including MET, KDR, and SOX3, which are associated with tumor invasiveness, malignancy, and unfavorable prognosis in glioblastoma patients. We also demonstrated the HGF-MET signaling axis as a key molecular determinant in GSC invasion, and we discovered that a significant association in HGF expression existed between mesenchymal phenotype and immune cell recruitment.CONCLUSIONSUpregulation of MET and mesenchymal cellular state are essential in generating HGF-mediated therapeutic responses. Our results provide an important framework for evaluating HGF-targeted therapy in future clinical settings.

Experimental & Molecular MedicineQ2 · MEDICINE

Preclinical development of a humanized neutralizing antibody targeting HGF

Q2 · MEDICINE

ArticleOA

Author: Park, Gunwoo ; Lee, Song-Jae ; Hong, Sung Hee ; Park, Young-Whan ; Kim, Jung Yong ; Kim, In-Hoo ; Kim, Tae Min ; Kim, In-Chull ; Song, Seong-Won ; Kim, Hyori ; Chung, Junho ; Kim, Yun-Hee ; Kim, Jung Ju ; Park, Jong Bae

Hepatocyte growth factor (HGF) and its receptor, cMET, play critical roles in cell proliferation, angiogenesis and invasion in a wide variety of cancers. We therefore examined the anti-tumor activity of the humanized monoclonal anti-HGF antibody, YYB-101, in nude mice bearing human glioblastoma xenografts as a single agent or in combination with temozolomide. HGF neutralization, The extracellular signal-related kinases 1 and 2 (ERK1/2) phosphorylation, and HGF-induced scattering were assessed in HGF-expressing cell lines treated with YYB-101. To support clinical development, we also evaluated the preclinical pharmacokinetics and toxicokinetics in cynomolgus monkeys, and human and cynomolgus monkey tissue was stained with YYB-101 to test tissue cross-reactivity. We found that YYB-101 inhibited cMET activation in vitro and suppressed tumor growth in the orthotopic mouse model of human glioblastoma. Combination treatment with YYB-101 and temozolomide decreased tumor growth and increased overall survival compared with the effects of either agent alone. Five cancer-related genes (TMEM119, FST, RSPO3, ROS1 and NBL1) were overexpressed in YYB-101-treated mice that showed tumor regrowth. In the tissue cross-reactivity assay, critical cross-reactivity was not observed. The terminal elimination half-life was 21.7 days. Taken together, the in vitro and in vivo data demonstrated the anti-tumor efficacy of YYB-101, which appeared to be mediated by blocking the HGF/cMET interaction. The preclinical pharmacokinetics, toxicokinetics and tissue cross-reactivity data support the clinical development of YYB-101 for advanced cancer.

100 Deals associated with Yooyoung Pharm Co. Ltd.

100 Translational Medicine associated with Yooyoung Pharm Co. Ltd.

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