RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) 是一家生物製藥公司，主要專注于開發幷銷售炎症性疾病和胃腸疾病及癌症治療方面的處于後期臨床試驗階段的專有口服小分子藥物。本公司今天宣布YELIVA™ (ABC294640) 用于晚期實體瘤的一期試驗取得積極的最終結果。
本次試驗在南卡羅萊納醫科大學進行，成功達到了主要和次要終點。一期試驗的最終結果顯示，該藥物耐受性良好，能够安全用于癌症患者身上，通過用藥劑量爲患者提供預計將具有治療活性的循環藥物水平。
“我們對于YELIVA™治療晚期實體瘤一期試驗的結果非常滿意。本次試驗證明了這一新型候選藥物的安全性、耐受性及潜在療效，本次試驗中多名患者雖然患的是晚期實體瘤，但他們的病情穩定下來，幷且獲得了顯著較長的無進展生存期，”RedHill醫學總監Terry Plasse博士表示，“我們對于YELIVA™用于多種腫瘤、炎症性和胃腸適應症的治療潜力滿懷期待，希望在今年年底啓動進一步的二期試驗。由于YELIVA™獨特的作用機制，我們還强烈認爲它能够結合幾款現有的領先腫瘤藥物來爲癌症患者帶來新的療效，我們目前正在探索潜在合作機會來評估YELIVA™作爲輔助療法。”
本次試驗中有21名晚期實體瘤患者接受YELIVA™治療，其中大部分是胃腸癌症患者，包括胰腺癌、結直腸癌和膽管癌在內。
本次試驗包括有史以來第一次將血漿鞘氨醇-1-磷酸（S1P）水平作爲鞘脂類靶向藥物活性的潜在藥效生物標記進行縱向分析；施用YELIVA™導致鞘氨醇-1-磷酸水平迅速地顯著下降，有多名患者疾病穩定期延長。
一期試驗獲得了美國國家癌症研究所授予給南卡萊羅納醫科大學Hollings癌症中心的撥款支持，它是美國國家癌症研究所指定的癌症中心。此外，還獲得了美國食品藥品監督管理局孤兒藥開發辦公室授予給Apogee生物技術公司的撥款支持。
YELIVA™治療難治性或復發性多發性骨髓瘤的一/二期試驗計劃在未來幾周啓動，本次試驗獲得了美國國家癌症研究提供給Apogee和杜克大學的200萬美元撥款支持；YELIVA™作爲輻射防護劑用于接受化療治療的癌症患者預防粘膜炎的二期試驗，計劃在2016年下半年啓動；YELIVA™用于治療晚期肝細胞癌的二期試驗計劃在2016年第三季度啓動，同樣獲得了美國國家癌症研究所授予給南卡羅萊納醫科大學的撥款支持。
YELIVA™ 是處于二期階段的專有口服鞘氨醇激酶-2（SK2）選擇性抑制劑，是首創新藥，具有抗癌和抗炎活性，靶向爲腫瘤、炎症性和胃腸適應症。
RedHill Biopharma Ltd介紹：
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家總部位于以色列的新興生物醫藥公司，主要專注于開發幷銷售治療炎症性疾病和腸胃疾病以及癌症方面的處于後期臨床試驗階段的專有口服小分子藥。 公司目前的産品管綫包括：(i) RHB-105 -治療幽門螺杆菌感染的口服混合藥，首個三期試驗獲得成功；(ii) RHB-104 -治療克羅恩病的口服混合藥，正在進行首個三期試驗以及治療多發性硬化症的二a期概念驗證試驗；(iii) BEKINDA™ (RHB-102) -日服一次的昂丹司瓊口服藥片製劑，正在美國進行治療急性腸胃炎和慢性胃炎的三期試驗，以及治療腹瀉型腸易激綜合征的二期試驗；(iv) RHB-106 -腸道準備藥物膠囊，已經授權給Salix Pharmaceuticals Ltd.；(v) YELIVA™ (ABC294640) -二期階段的口服SK2選擇性抑制劑，是首創新藥，靶向爲多種腫瘤、炎症性和胃腸道適應症；(vi) MESUPRON® – 處于二期試驗階段的uPA抑制劑口服膠囊，是首創新藥，靶向爲胃腸和其他實體瘤；(vii) RP101 – Hsp27抑制劑口服藥片，是處于二期試驗階段的首創新藥，靶向爲胰腺癌和其他胃腸癌，RedHill擁有該藥物的收購選擇權；(viii) RIZAPORT™ (RHB-103) -利扎曲坦口服薄膜製劑，用于治療急性偏頭痛，正在與美國食品藥品監督管理局討論新藥申請，2015年10月獲准在德國上市；以及(ix) RHB-101 -心血管藥物卡維地洛日服一次的口服藥片製劑。
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 development 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 U.S. 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 studies 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 Securities 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.
公司連絡人：
Adi Frish
業務發展和許可高級副總裁
RedHill Biopharma
+972-54-6543-112
[email protected]
投資者關係連絡人（美國）：
Marcy Nanus
高級副總裁
The Trout Group
+1-646-378-2927
[email protected]
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