北極星新藥 美癌症年會報喜 2016年06月03日 04:10 杜蕙蓉／台北報導 F-PG（6550，北極星）在ASCO年會召開前夕發布利多，執行長吳伯文表示，主力產品ADI-PEG 20將有3篇不同的癌症報告分為三種不同的形式在癌症年會發表，其中胰臟癌的論文將率先發表，該新藥與 Gem+Nab-paclitaxel的聯合用藥效果良好下，也規劃年底向美國FDA申請胰臟癌第II/III期關鍵臨床實驗。吳伯文表示，該公司開發的ADI-PEG 20，今年在ASCO年會上將有3篇不同的癌症報告，分別是最高級別口頭發表、海報發表以及論文發表。除了胰臟癌率先以論文發表外，其他兩項肝癌和肺間皮癌的論文因ASCO規定將於下周發佈。吳伯文表示，該公司在世界最大癌症研究機構-紐約紀念斯隆-凱特琳癌症中心（Memorial Sloan Kettering Cancer Center) 進行的ADI-PEG 20與Gem+Nab-paclitaxel聯合用藥的第一期臨床實驗結果顯示其效果超出預期。此試驗約4成的病患腫瘤縮小一半以上，而且高達9成的病人病情獲得穩定控制。相較於標準療法，腫瘤反應率提高將近一倍，沒有看到與ADI-PEG 20藥物相關的任何副作用。因此，北極星在今年4月11日在紐約舉行專家咨詢會議中，規劃預計今年年底向美國FDA申請胰臟癌第II/III期關鍵臨床實驗，最快可以於明年上半年開始收病人。(工商時報)
ADI-PEG 20 plus Gemcitabine and nab-Paclitaxel Shows Robust Anti-tumor Activity in Advanced Pancreatic Cancer/SAN DIEGO, June 3, 2016 /PRNewswire/ -- Polaris Group announced today results from an ongoing phase 1b study conducted at Memorial Sloan Kettering Cancer Center that tests combining ADI-PEG 20 with gemcitabine and nab-Paclitaxel (ADIGemPac) in patients with advanced pancreatic cancer. The results will be presented at the American Society of Clinical Oncology's 2016 annual meeting in Chicago. Eighteen patients, including 4 patients with 1 prior line of therapy, were enrolled in the single-arm, open label study to assess the safety and preliminary activity of ADIGemPac. Eight patients (44%), including 1 previously treated patient, showed a partial response, and 8 patients (44%) had stable disease for a disease control rate of 88%. With 9 patients still receiving treatment, the median progression free survival is currently 7.2 months, and median overall survival has not yet been reached. Patients have reported no ADI-PEG 20-related grade 3-5 toxicities. "We are encouraged to see robust anti-tumor activity demonstrated by ADIGemPac in both untreated and pre-treated advanced pancreatic cancer patients and are excited to consider further clinical investigations in order to bring a safe and effective treatment to these patients," said John Bomalaski, M.D., Executive Vice President, Medical Affairs at Polaris Pharmaceuticals, Inc.
About ADI-PEG 20: ADI-PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient's normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI-PEG 20.
About Polaris Group:Polaris Group specializes in the research and development of protein drugs to treat cancer and other debilitating diseases. In addition to the ADI-PEG 20 program, Polaris Group is developing other biotherapeutic agents including a small molecule drug program that utilizes a rational structure-based approach to design novel compounds that inhibit the biological function of cancer-related protein targets.
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