tyroserleutide (YSL) 酪丝亮肽: 肝癌治療 (康哲药业)

康哲药业披露治肝癌1类新药注射用酪丝亮肽临床研究初步结果 发布日期：2014-03-05来源：新药汇 康哲药业披露一项主题为"随机、双盲、安慰剂对照评价注射用酪丝亮肽治疗肝细胞癌的安全性、有效性期多中心临床研究" (CMS024 临床试验)的有效性分析的初步结果。注射用酪丝亮肽(CMS024)是康哲药业自主研发的国家1.1类新药，而所披露的统计数据乃由独立的统计机构提供。

CMS024试验结果总体未能达标 康哲药业认为，CMS024临床试验结果显示，针对病情较轻的人群示器如无分支癌栓的受试者)、以总生存期(OS)作为主要疗效指标的进一步临床研究，是很有价值的。至于有分支癌栓患者病情严重，发快，药物暴露时间短，可能导致药物尚未起效受试者就已发，而发后，绝大部分受试者停止用药。公司通过对病情比较严重的有分支癌亚组(149例)和相对病情比较轻的无分支癌亚组别(149例)进行的试验结果表明,两者无复发生存期(RFS)和总生存期(OS)指标均差于预不达标准,表明该药物有待完善。无分支癌栓亚组试验表明CMS024在总生存期改善方面有重要意义。试验结果表明,在无分支癌栓亚组中的总生存期(OS)已接近显着性差异, 随机后600天的生存率差异超过20%,生存改善趋势明显。总生存期(OS) 是公认的肿瘤疗效评价金标准,总生存期(OS)改善拥有重要意义。 临床试验结果观察到，在无分支癌栓亚组中的总生存期已接近显着性差异，随机后600天的生存率差异超过20%，而总生存期改善的意义巨大， 康哲药业认为有责任向国家食品药品监督管理总局及时沟通。该公司拟开展CMS024下一步临床试验， 并将继续承担临床试验的费用。同时，公司已就该趋势同研究者和统计方进行了紧急磋商，其均表示愿意和集团合作再次开展CMS024下一步的临床试验， 期望于本年度内开启。 深圳市康哲药业有限公司（又名"CMS"）成立于1995年，是中国最大的处方药产品销售推广服务提供商。公司主力产品抗抑郁药物黛力新和的胆石药物优思弗刚性需求刚性需求较强,心血管药物新活素等也正迅速被许多医院接受。

Effects of a novel tripeptide, tyroserleutide (YSL), on cell cycle progression of human hepatocellular carcinoma.  Anticancer Drugs. 2009 Aug;20(7):534-42 The objective of this study was to develop a new small molecular peptide, tyrosyl-seryl-leucine (tyroserleutide, YSL), as an anticancer drug. Our study investigated the effects of YSL on human hepatocellular carcinoma and cyclin, and explored its antitumor mechanism in vitro. In-vitro effects of YSL on human hepatocarcinoma cell BEL-7402 were assayed by the MTS (dimethylthiazol-carboxymethoxyphenyl-sulfophenyl - tetrazolium inner salt) method. The ultrastructure of tumor cells was observed by electron microscopy. DNA ladder was used to investigate apoptosis of BEL-7402 cells. The effects of YSL on the cell cycle of BEL-7402 cells were determined by flow cytometry. Expression of PCNA, P21, and P27 were investigated by real-time PCR and western blot in BEL-7402 cells. YSL inhibited the proliferation of BEL-7402 cells in vitro, induced DNA fragmentation, and changed their ultrastructure evidently, resulting in the necrosis and apoptosis of tumor cells. YSL interrupted cell cycle of tumor cells at G0/G1 and postponed their proceedings. YSL markedly enhanced the mRNA and protein expression of P21 and P27, and decreased the expression of PCNA of tumor cells. In conclusion, YSL significantly inhibited the growth of human hepatocellular carcinoma BEL-7402 cells and its anti-tumor effects may result from the upregulation of cyclin P21 and P27, and downregulation of cyclin PCNA.

康哲(867)治療肝細胞癌新葯實驗獲初步成效 今復牌14年3月5日公佈旗下新葯注射用酪絲亮肽已獲得其在治療肝細胞癌有效性分析的初步結果。該結果表明，針對病情較輕的人群(如無分支癌栓的受試者)、以總生存期(OS)作為主要療效指標的進一步臨床研究，是很有價值的。集團期望新葯的下一步臨床試驗將於本年度內開啟。 公司股票已於今早復牌。

康哲（0867）公布注射用酪絲亮肽治療肝細胞癌之臨床研究結果《經濟通通訊社5日專訊》康哲（00867）公布注射用酪絲亮肽（CMS024）治療肝細胞癌之臨床研究結果。該藥屬自主研發國家1.1類新藥，臨床測試由復旦大學附屬中山醫院牽頭，目的是透過隨機、雙盲、安慰劑對照、多中心原則評價該藥之有效性和安全性。