RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) 是一家生物制药公司，主要专注于开发幷销售炎症性疾病和胃肠疾病及癌症治疗方面的处于后期临床试验阶段的专有口服小分子药物。本公司今天宣布YELIVA™ (ABC294640) 用于晚期实体瘤的一期试验取得积极的最终结果。
本次试验在南卡罗莱纳医科大学进行，成功达到了主要和次要终点。一期试验的最终结果显示，该药物耐受性良好，能够安全用于癌症患者身上，通过用药剂量为患者提供预计将具有治疗活性的循环药物水平。
“我们对于YELIVA™治疗晚期实体瘤一期试验的结果非常满意。本次试验证明了这一新型候选药物的安全性、耐受性及潜在疗效，本次试验中多名患者虽然患的是晚期实体瘤，但他们的病情稳定下来，幷且获得了显著较长的无进展生存期，”RedHill医学总监Terry Plasse博士表示，“我们对于YELIVA™用于多种肿瘤、炎症性和胃肠适应症的治疗潜力满怀期待，希望在今年年底启动进一步的二期试验。由于YELIVA™独特的作用机制，我们还强烈认为它能够结合几款现有的领先肿瘤药物来为癌症患者带来新的疗效，我们目前正在探索潜在合作机会来评估YELIVA™作为辅助疗法。”
本次试验中有21名晚期实体瘤患者接受YELIVA™治疗，其中大部分是胃肠癌症患者，包括胰腺癌、结直肠癌和胆管癌在内。
本次试验包括有史以来第一次将血浆鞘氨醇-1-磷酸（S1P）水平作为鞘脂类靶向药物活性的潜在药效生物标记进行纵向分析；施用YELIVA™导致鞘氨醇-1-磷酸水平迅速地显著下降，有多名患者疾病稳定期延长。
一期试验获得了美国国家癌症研究所授予给南卡莱罗纳医科大学Hollings癌症中心的拨款支持，它是美国国家癌症研究所指定的癌症中心。此外，还获得了美国食品药品监督管理局孤儿药开发办公室授予给Apogee生物技术公司的拨款支持。
YELIVA™治疗难治性或复发性多发性骨髓瘤的一/二期试验计划在未来几周启动，本次试验获得了美国国家癌症研究提供给Apogee和杜克大学的200万美元拨款支持；YELIVA™作为辐射防护剂用于接受化疗治疗的癌症患者预防粘膜炎的二期试验，计划在2016年下半年启动；YELIVA™用于治疗晚期肝细胞癌的二期试验计划在2016年第三季度启动，同样获得了美国国家癌症研究所授予给南卡罗莱纳医科大学的拨款支持。
YELIVA™ 是处于二期阶段的专有口服鞘氨醇激酶-2（SK2）选择性抑制剂，是首创新药，具有抗癌和抗炎活性，靶向为肿瘤、炎症性和胃肠适应症。
RedHill Biopharma Ltd介绍：
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家总部位于以色列的新兴生物医药公司，主要专注于开发幷销售治疗炎症性疾病和肠胃疾病以及癌症方面的处于后期临床试验阶段的专有口服小分子药。公司目前的产品管线包括：(i) RHB-105 -治疗幽门螺杆菌感染的口服混合药，首个三期试验获得成功；(ii) RHB-104 -治疗克罗恩病的口服混合药，正在进行首个三期试验以及治疗多发性硬化症的二a期概念验证试验；(iii) BEKINDA™ (RHB-102) -日服一次的昂丹司琼口服药片制剂，正在美国进行治疗急性肠胃炎和慢性胃炎的三期试验，以及治疗腹泻型肠易激综合征的二期试验；(iv) RHB-106 -肠道准备药物胶囊，已经授权给Salix Pharmaceuticals Ltd.；(v) YELIVA™ ( ABC294640) -二期阶段的口服SK2选择性抑制剂，是首创新药，靶向为多种肿瘤、炎症性和胃肠道适应症；(vi) MESUPRON® – 处于二期试验阶段的uPA抑制剂口服胶囊，是首创新药，靶向为胃肠和其他实体瘤；(vii) RP101 – Hsp27抑制剂口服药片，是处于二期试验阶段的首创新药，靶向为胰腺癌和其他胃肠癌，RedHill拥有该药物的收购选权；(viii) RIZAPORT™ (RHB-103) -利扎曲坦口服薄膜制剂，用于治疗急性偏头痛，正在与美国食品药品监督管理局讨论新药申请，2015年10月获准在德国上市；以及(ix) RHB-101 -心血管药物卡维地洛日服一次的口服药片制剂.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects, ” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation , risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate develop ment efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to establish and maintain corporate collaborations; (vi) the Company’s ability to acquire products approved for marketing in the US that achieve commercial success and build its own marketing and commercialization capabilities; (vii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical st udies or clinical trials; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) the impact of the political and security situation in Israel on the Company’s business. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Secu rities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 25, 2016. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.
公司连络人：
Adi Frish
业务发展和许可高级副总裁
RedHill Biopharma
+972-54-6543-112
[email protected]
投资者关系连络人（美国）：
Marcy Nanus
高级副总裁
The Trout Group
+1-646-378-2927
[email protected]
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