北極星ADI-PEG 20 由DesigneRx Pharmaceuticals生產

北極星返鄉 抗癌藥將問世 2015-04-20 04:01:45 經濟日報 記者黃文奇／台北報導北極星藥業回來了，董事長吳伯文將宣布，公司預備規劃回台上櫃，挾抗癌新藥技術平台「ADI-PEG 20」（以下簡稱ADI）已在全球完成11個臨床試驗，還有11個正在進行中的臨床試驗，針對十多項癌症適應症同時進行測試的優勢，業界認為，該產品有機會搶在浩鼎之前，成為華人第一個國際性的蛋白質新藥。ADI將完成全球多國多中心臨床三期肝癌試驗，在美國知名癌症中心MSKCC領導下，在美、台、英、義、中、 韓各國歷時三年半共收錄636名末期肝癌病人，其中台灣就有194人，公司預期在今年底完成數據分析，如果一切順利，可望明年下半年在美、歐、台取得藥證。自2005年以來，所有ADI針劑都是由北極星藥業在美國的北加州子公司DesigneRx Pharmaceuticals生產。早期的臨床研究著重於單一治療，包括肝癌、黑色素皮膚癌以及肺間皮癌的臨床二期都有良好療效。在台灣更有以恩慈療法方式（compassionate use）申請特許進口而多次成功治癒肝癌末期患者的紀錄。目前將完成的全球肝癌第三期臨床試驗，也是以單一用藥、第二線治療模式。最近幾年北極星藥業與美、英、台各地20多個癌症中心及大學合作，探討以聯合用藥方式將ADI與一種或多種化療藥物組合針對各種癌症進行治療，發現聯合用藥對多種癌症可達到更加顯著的療效。目前正進行中的聯合用藥臨床試驗，包括在美國抗癌中心MD Anderson的黑色素癌、子宮頸癌、肝癌、膽管癌、乳癌，在MSKCC的胰臟癌、肝癌，在加州大學的攝護腺癌及非小細胞肺癌，以及在英國倫敦Barts醫院與劍橋的肺間皮癌、非小細胞肺癌、及腦癌。公司更規劃在今年第3季展開第二個全球多國多中心的第三期肝癌臨床試驗，該試驗將以ADI搭配順鉑（cisplatin）做一線治療，直接和目前唯一上市的肝癌藥雷沙瓦（Nexavar）做對比。北極星集團旗下擁有北極星藥業以及關係企業瑞華藥業，兩者都是新藥開發公司，但前者聚焦抗癌用藥開發，後者則同時具備蛋白質藥量產能力。瑞華除持有北加DesigneRx廠外，也在大陸成都高新西區建設未來可以供應全球市場需求的新廠。當初吳伯文因各項因素黯然捨台就陸設廠辛苦備嘗，他透露，未來仍希望把其他機會留給台灣，換言之，回台上市櫃僅是序曲。

DRX Pharmaceuticals DesigneRx Pharmaceuticals, Inc. was founded in 2002 in California.The company built a cGMP facility for biologics in 2004 and began to provide ADI-PEG 20 for several early stage clinical studies in Europe, the USA and Taiwan in 2005.As an affiliate of the Polaris Group companies, DesigneRx is responsible for production of study drugs for all Polaris clinical studies.

DRX Shanghai DesigneRx (Shanghai) was founded in 2007 in Shanghai, China.The company constructed an animal research facility and a cell culture laboratory in 2008.As an affiliate of the Polaris Group companies, DesigneRx (Shanghai) is responsible for the pre-clinical pharmacokinetic analysis, in vitro testing of new drug candidates in selected tumor cell lines and in vivo testing of new drug candidates in selected xenograft models.

DRX Chengdu DesigneRx (Chengdu) was founded in 2013 in Chengdu Sichuan, China.As an affiliate of the Polaris Group companies, DesigneRx (Chengdu) is the future site of a large scale manufacturing facility for ADI-PEG 20.ADI is formulated with polyethylene glycol (PEG) of 20,000 dalton molecular weight to increase the circulating half life and decrease antigenicity of ADI. Similar pegylation technology has been used with microbially-derived therapeutic proteins for systemic delivery of other anticancer drugs. Asparaginase provides a successful example of a microbial protein that, in its pegylated form (Oncaspar®), has been used as front-line therapy against childhood leukemia for over 20 years with few serious side effects.Formulating the ADI with PEG also allows for the drug to be administered by intramuscular (i.m.) injection which avoids possible complications known to be associated with multiple intravenous administrations. Furthermore, i.m. injections can readily be administered in an outpatient hospital setting, in a physician's office or even in a patient's home.ADI-PEG 20 has been granted orphan drug status for hepatocellular carcinoma in the United States and Europe. It has also been granted orphan drug status for melanoma in the United States. The FDA has offered Special Protocol Assessment in the United States and the EMEA has offered Protocol Assistance in Europe.Broad patent protection has been obtained through a number of patents issued or pending in the United States and worldwide.