台微體長效緩釋BioSeizer (關節炎藥TLC599) 完成40人收案 (phase I/II)

台微體 關節炎用藥TLC599 完成臨床一／二期收案 2016年06月24日 04:10 杜蕙蓉／台北報導 台微體（4152）宣布，其自行研發之關節炎用藥TLC599已順利完成40人的臨床一／二期收案，初步藥效結果預計將於下半年揭曉。目前全球關節炎用藥的市場約300億美元，年複合成長率7.2％，初估2018年市場規模約380億美元。TLC599是台微體研發的長效緩釋BioSeizer傳輸平台包裹類固醇藥物，注射於患處的關節炎用藥。BioSeizer的多層膜結構一方面可讓未經包裹的藥物得以迅速發揮藥效，另一方面又可讓被包裹的藥物透過逐層崩解的技術延長藥效，讓病患關節發炎的症狀不但可以迅速得到舒緩，也可將藥效延長至12周，並能在一年四次的注射頻率下有效地舒緩病患的疼痛與不適。台微體指出，收案的40人中，目前已有29名病患完成了12周的觀察期，初步結果頗為振奮人心。公司預計將於年底前，揭曉40名病患的臨床藥效結果。另外GBI Research的分析則顯示，全球關節炎用藥的市場在2010年時已達206億美金，並估計將於2010至2018年間以7.2％的複合成長率於2018年達到380億美元。(工商時報)

Official Title:   A Randomized, Open-label, Parallel, Phase I/II Single-Dose Administration Trial of TLC599 in Subjects With Osteoarthritis of the Knee. This study is currently recruiting participants. (see Contacts and Locations) Verified June 2016 by Taiwan Liposome Company

Sponsor: Taiwan Liposome Company Information provided by (Responsible Party): Taiwan Liposome Company ClinicalTrials.gov Identifier: NCT02803307 First received: May 23, 2016 Last updated: June 16, 2016 Last verified: June 2016 Purpose This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee. 

Primary Outcome Measures: Safety parameters [ Time Frame: up to 12 weeks after dosing ] [ Designated as safety issue: Yes ] Safety parameters will be assessed as measured by adverse events (AEs), changes in physical examinations, vital signs, and clinical laboratory results  

Secondary Outcome Measures: Pain score (VAS) [ Time Frame: Questionnaire will be collected at baseline, Week 1, Week 4, Week 8, Week 12. ] [ Designated as safety issue: No ] WOMAC questionnaire [ Time Frame: Questionnaire will be collected at baseline, Week 1, Week 4, Week 8, Week 12. ] [ Designated as safety issue: No ] IGART questionnaire [ Time Frame: Questionnaire will be collected at Week 1, Week 4, Week 8, Week 12. ] [ Designated as safety issue: No ] 

Estimated Enrollment:  40 Study Start Date:       June 2015 Estimated Study Completion Date:       December 2016 Estimated Primary Completion Date:        September 2016 (Final data collection date for primary outcome measure) Arms Assigned Interventions

Experimental: 6 mg TLC599 6 mg DSP with 50 μmol PL Drug: TLC599 Single dose via intra-articular injection

Experimental: 12 mg TLC599 12 mg DSP with 100 μmol PL Drug: TLC599 Single dose via intra-articular injection  Detailed Description: Protocol No: TLC599A1001  Name of Finished Product: TLC599 

Title of Study:  A Randomized, Open-label, Parallel, Phase I/II Single-Dose Administration trial of TLC599 in Subjects with Osteoarthritis (OA) of the Knee  Methodology This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee. 

Study duration:  The trial will last 14 weeks including a 14-day screening period and a 12-week follow-up period. 

Eligibility  Ages Eligible for Study:  20 Years and older Genders Eligible for Study:  Both Accepts Healthy Volunteers:  No Criteria Inclusion Criteria:  Male or female subjects, at least 20 years of age Documented diagnosis of OA of the knee for at least 6 months At least a grade 2 severity based on the Kellgren and Lawrence Grading Scale VAS score of ≥ 4 at baseline

Exclusion Criteria:  Subjects who received systemic corticosteroids for the last 30 days prior to baseline Subjects who received non-steroidal anti-inflammatory drug (NSAID), analgesics, or rehabilitations therapy within 7 days prior to baseline History of rheumatoid arthritis or other autoimmune disease Clinical signs and symptoms of acute infection or infection related inflammation in the other knee before dosing History of infective arthritis, suspected or concurrent infection, or suspected or confirmed crystal diseases (gout or pseudogout) of the study knee Concurrent systemic active or uncontrolled infectious disease A history of treated malignancy which is disease free for ≤ 5 years. (The malignancy does not include non-basal-cell carcinoma of skin or carcinoma-insitu of the uterine cervix) History of acquired or congenital immunodeficiency diseases Platelet count < 80,000/μl, or blood coagulation disorders, including subjects with hemophilia, decompensated liver cirrhosis or uremia Stroke or myocardial infarction within 3 months prior to the screening visit Use of intra-articular corticosteroid, hyaluronic acid, or other intra-articular injection in the study knee joint within 3 months prior to the screening visit Unstable study knee joint, including anterior cruciate ligament, any surgery to the study knee within the 12 months prior to the screening visit, and any prior arthroscopic or open surgery of the study knee or any planned/anticipated surgery during the study period Any skin lesion/breakdown at the anticipated injection site or any condition that impairs penetration of the study knee joint space Female subjects who are pregnant, nursing, planning pregnancy, or who are of childbearing potential and not using reliable means of contraception 15.Known allergy or hypersensitivity to the study drug or its components  

Locations Taiwan MacKay Memorial Hospital      Recruiting Taipei, Taiwan, 104 Contact: Shu-Wan Yeh/Taipei Medical University Hospital        Recruiting Taipei, Taiwan, 110 Contact: Lellian Wang/Taipei Veterans General Hospital   Recruiting Taipei, Taiwan, 112 Contact: Ying-Chein Lee/Sponsors and Collaborators Taiwan Liposome Company