中裕TMB-355 phaseIIb & phase III design (FDA phaseIII送件人數40人)2017Q1 獲證 !

中裕愛滋新藥 三期臨床收案達標 發稿時間：2016/04/28 08:40最新更新：2016/04/28（中央社記者韓婷婷台北28日電）中裕公告愛滋病新藥TMB-355三期臨床試驗已達到收案目標，試驗預計今年10月到11月間完成，推估2017年第1季可獲美國FDA藥證。中裕公告截止至美國時間2016年4月27日，愛滋病新藥TMB-355三期臨床試驗（study 301）美國地區實際收案人數為36名，台灣地區收案人數4名，將來給美國FDA送件人數共40人，達到且超過美國FDA的要求。美國FDA要求在美國收案數為30人以上，台灣地區以多國多中心方式同步進行臨床試驗，預計在台灣收案人數需達總人數1/10。中裕指出，依據臨床試驗設計，預計25週後將結束相關治療，因此預計完成時間約在10月底至11月初附近，合理推測預計美國FDA核准藥證之時間點約在2017年第1季左右，惟藥證實際核准時間及准駁與否為美國FDA主管機關職權。由於中裕臨床試驗設計是open label並非雙盲測試，無需臨床試驗結束後解盲過程。換句話說「浩鼎解盲」事件不會在中裕身上重演。有關主要評估指標（primary endpoint）結果，考慮資料整理及分析時間，預計 5月20日前後可知曉相關資訊，將諮詢相關法規或主管機關意見後，於資訊完成後第一時間以重大訊息適度揭露相關訊息予投資大眾，以求資訊對等性及一致性。TMB-355是一種治療愛滋病的單株抗體蛋白質藥物；靜脈注射型臨床三期試驗申請已獲得美國FDA及TFDA核可，該試驗現正進行中。靜脈注射型三期臨床試驗已支付委託試驗CRO支出約新台幣3388萬元。肌肉及皮下注射型臨床一/二期試驗2013年已獲得台灣衛生署核准，歷經數次計畫修正核准，該試驗現正進行中。肌肉及皮下注射型一/二期試驗已支付委託試驗CRO支出約新台幣2452萬元。新藥開發時程長、投入經費高且未保證一定能成功，可能使投資面臨風險，投資人應審慎判斷謹慎投資。1050428

Official Title:   A Phase 2b, Randomized, Double-Blinded, 48-Week, Multicenter, Dose-Response Study of Ibalizumab Plus an Optimized Background Regimen in Treatment-Experienced Patients Infected With HIV-1(Amended to 24-Weeks) Study Design:    Allocation: Randomized Endpoint Classification: Pharmacokinetics/ Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Purpose: The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks. In addition to study drug, all patients will receive an optimized background regimen (OBR), which is a standard-of-care regimen selected by the investigator prior to randomization that is comprised of 2-4 antiretroviral agents. These agents must have been approved by the local regulatory agency or be available through expanded-access programs for treatment of human immunodeficiency virus (HIV). Enrollment: 113 Study Start Date: August 2008 Study Completion Date: April 2011 

Official Title:   A Phase 3, Multicenter, Expanded Access Study of Ibalizumab Plus an Optimized Background Regimen (OBR) in Treatment-Experienced Patients Infected With Multi-Drug Resistant (MDR) HIV-1  Study Type: Interventional Study Design: Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment Purpose: Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system cells (CD4+ or T-cells) the virus typically infects. Ibalizumab is intended for use in combination with other anti-HIV drugs in people with multi-drug resistant HIV and limited treatment options. This study will collect further information on the safety and tolerability of intravenously administered (IV) ibalizumab combined with an optimized background regimen for treating multi-drug resistant HIV-1 infection, and will provide continuing access to ibalizumab for patients completing a prior ibalizumab clinical trial. Estimated Enrollment: 50 Study Start Date: March 2016 Estimated Study Completion Date: March 2017 Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure) Detailed Description: Participants will enroll into one of two study cohorts. Cohort 1 will provide continued administration of IV ibalizumab for patients completing a prior ibalizumab clinical trial (TaiMed-sponsored or Investigator-Sponsored). Patients will continue to receive IV infusions of ibalizumab at the dosage assigned in the previous study - either 800 mg once every two weeks, or 2000 mg once every four weeks. Cohort 2 will provide IV ibalizumab, 800 mg once every two weeks, for qualifying patients with multi-drug resistant HIV-1 and limited treatment options who have never previously received ibalizumab. Participants may continue in this study for 48 weeks, or until ibalizumab becomes commercially available, whichever occurs first.