PI-88承諾vs騙局 !

駁炒股騙局　基亞董座：不是牛皮吹破 2014年08月14日09:12 昨日吞下第13根跌停的生技股基亞（3716），遭《財訊》雙週刊報導，開發肝癌新藥為騙局，新藥並無顯著療效，董事長張世忠表示，報導與事實嚴重不符，已經委任律師，發函要求《財訊》更正，並採取必要的法律行動。他強調，基亞過去14年來到現在，就是要把PI-88開發成功照顧病人，「這是承諾，絕對不是騙局。」基亞今早開盤後仍是無量跌停，股價鎖在161元。張世忠今早在櫃買中心重訊時指出，報導中所稱美國國家衛生研究院（NIH）之官方報告並非事實，實際上作者是中國廣西醫科大學附設腫瘤醫院人員在《斯堪地那維亞腸胃學期刊》所發表的論文，完全與美國國家衛生研究院無關。張世忠更說，報導指出新藥沒有顯著療效也是錯誤，PI-88必須經過更大型的臨床試驗，才能驗證其對肝癌術後復發的療效，而第3期臨床試驗尚在進行中，《財訊》報導完全背離事實。「PI-88是試驗中新藥，第3期臨床試驗尚未完成，雖然其中試驗位達到預期療效，但成敗尚未有最後定論。」張世忠說，新藥開發確實有失敗風險，但《財訊》引用錯誤資訊惡意解讀，將採取必要法律行動。但被問及期中試驗不如預期造成股價暴跌，是否是「牛皮吹破」，張世忠仍表示，做新藥當然有所期待，而且是有所本，不是牛皮吹破，也不是試驗失敗，只是未達預期，「公司只要繼續願意下去，帶著成功的期待是必然的，但成功率多少就無法公開，公司領導人不能沒有證據的忙碌樂觀。」對於如果PI-88試驗失敗，公司的營運前景，張世忠說，基亞過去14年不是只有做PI-88，「是重點，不是全部」，基亞還有其他布局，還有第2個臨床試驗，下個月就會開始推動，也是肝癌藥物，已經向台灣、韓國遞出臨床試驗申請，會繼續走下去。（林海／台北報導）

A meta-analysis of adjuvant therapy after potentially curative treatment for hepatocellular carcinoma. Department of General Surgery, The First Hospital of Lanzhou University, Gansu, China. Can J Gastroenterol. 2013 Jun;27(6):351-63.

BACKGROUND: The high recurrence rate of hepatocellular carcinoma (HCC) after potentially curative treatment determines the long-term prognosis. OBJECTIVE: To evaluate the efficacy and safety of adjuvant therapies in patients with HCC who have undergone hepatic resection, transplantation or locoregional ablation therapy. METHODS: Several databases were searched to identify randomized controlled trials (RCTs) fulfilling the predefined selection criteria. Meta-analyses were performed to estimate the effects of adjuvant therapies of any modality on recurrence-free survival (RFS) and overall survival (OS). RESULTS: Eight adjuvant modalities were identified from 27 eligible RCTs conducted predominantly in Asian populations comparing adjuvant with no adjuvant therapy. Adjuvant chemotherapy, internal radiation and heparanase inhibitor PI-88 therapy failed to improve RFS or OS, while interferon (IFN) therapy yielded significant survival results. The findings of adjuvant vitamin analogue therapy required further examination. Adjuvant adoptive immunotherapy conferred significant benefit for RFS but not for OS. Although cancer vaccine therapy and radioimmunotherapy may improve survival after radical surgery, the results were from single, small-scale trials. Severe side effects were observed in the studies of adjuvant chemotherapy and of IFN therapy. CONCLUSIONS: Adjuvant IFN therapy can improve both RFS and OS; however, the benefits of using this agent should be weighed against its side effects. Combination of systemic and transhepatic arterial chemotherapy is not recommended for HCC after potentially curative treatment. Other adjuvant therapies produce limited success for survival. Additional RCTs with proper design are required to establish the role of adjuvant therapies for HCC.