藥華生技展傳捷報！皮膚新藥攜手美大咖 進FDA臨床1期 鉅亨網記者張旭宏 台北 2014-07-25 08:25 藥華藥總經理林國鐘宣布日前從美商Kinex取得治療皮膚病新藥的大中華區使用授權，美商Kinex決定率先採用藥華藥的軟膏製劑發展成為治療皮膚癌新藥actinic keratosis KX2-391，已獲美國FDA核准進入一期人體臨床試驗。(鉅亨網記者張旭宏攝) 新藥廠藥華醫藥(6446-TW)生技展傳捷報！宣布日前從美商Kinex取得治療皮膚病新藥的大中華區使用授權，除按規劃將於今年底前進行牛皮癬適應症的一期臨床試驗外，同時美商Kinex決定率先採用藥華藥的軟膏製劑發展成為治療皮膚癌新藥actinic keratosis KX2-391，已獲美國FDA核准進入一期人體臨床試驗。 藥華藥總經理林國鐘表示，皮膚病新藥年底前進行牛皮癬適應症的一期臨床試驗計畫不變外，目前因為領先Kinex將該款新藥發展成為軟膏製劑(ointment)，且研究進展良好，美商Kinex已決定率先採用藥華醫藥的軟膏製劑發展成為治療皮膚癌新藥actinic keratosis KX2-391，目前獲美國FDA核准進入一期人體臨床試驗，顯示台灣新藥的研發能力，及醫華醫藥的競爭力，絕對可與國際大廠並駕齊驅。 林國鐘指出，此次Kinex送件申請FDA做一期臨床試驗所依據的科學研究化學、製造和管制(Chemistry, manufacture and control，簡稱CMC)，是由公司技術團隊所領導獨立完成。CMC的研究主要是為試驗藥物的品質與安全做把關，要確保其原料藥與成品的組成、製造過程及其管控等無安全疑慮，若沒有CMC科學研究的支持，美國FDA不會同意准許進行人體臨床試驗。 林國鐘強調，此次美商Kinex以藥華藥所做的CMC研究報告取得FDA同意進入臨床試驗，無疑是對公司新藥研發技術與競爭力的再次肯定，對公司即將進行的牛皮癬新藥臨床試驗做了背書。
Kinex Pharmaceuticals Announces Allowance of the Investigational New Drug (IND) application for KX2-391 Ointment by the United States Food and Drug Administration (FDA) Kinex Pharmaceuticals announced the receipt of an allowance by the US FDA for the Company's KX2-391 Ointment for the commencement of a Phase I clinical study in actinic keratosis. This is the Company's third IND to be allowed by the US FDA in the past 12 months. KX2-391 is a synthetic, orally active and highly selective inhibitor of Src tyrosine kinase signaling and tubulin polymerization. KX2-391 promotes the induction of p53, G2/M arrest of proliferating cell populations and subsequent apoptosis via the stimulation of Caspase-3 and PARP cleavage. Potent inhibition of the growth of human keratinocytes and several melanoma cell lines in vitro suggests the potential clinical activity for actinic keratosis and dermatologic malignancies. In addition, KX2-391 has also been observed to inhibit T cell migration and endothelial tubule formation in vitro, suggesting additional potential therapeutic benefits for skin conditions like psoriasis where pathology is supported by lymphocyte infiltration, inflammation, and/or angiogenesis."The encouraging pre-clinical data for KX2-391 Ointment has led us to progress into this clinical study. Actinic keratosis is a pre-malignant condition and fits nicely into our oncology portfolio," said Dr. Rudolf Kwan, Chief Medical Officer of Kinex Pharmaceuticals. Kinex has licensed out the use of KX2-391 for dermatological indications in the Greater China Territory to a company specializing in pharmaceutical formulations, PharmaEssentia Corp. (Taipei, Taiwan). The scientific leader of this project at PharmaEssentia, Dr. Jer Hsu stated, "I would like to congratulate our team for the successful development of the KX2-391 ointment formulation in collaboration with our excellent collaborative partner, Kinex Pharmaceuticals. We are also leading the effort to advance this formulation for the clinical indication of psoriasis in Taiwan." Dr. KoChung Lin, CEO of PharmaEssentia said "We are delighted to see the successful collaboration in the allowance for the KX2-391 IND for Actinic Keratosis by US FDA. We are also looking forward to applying for a Taiwan IND for KX2-391 ointment and launching our clinical development program for psoriasis in Taiwan. Our collaboration with Kinex has been rewarding and we will use our joint momentum to bring KX2-391 Ointment into the clinic in Asia, expeditiously." KX2-391 is also being developed as an oral agent for oncology indications and has been tested in four clinical studies, thus far. In defining its pharmacological activity in tumor cells, both in vitro and in vivo, KX2-391 has been shown to have potent activity against a wide range of solid tumors as well as leukemia cell lines, including cell lines that are resistant to commonly used cancer drugs. Kinex has also partnered with Hanmi Pharmaceuticals (Seoul, Korea) to develop the oral formulation of KX2-391 for oncology indications in the Korea and greater ChinaTerritory. In partnership with Hanmi Pharmaceuticals, the safety, tolerability and pharmacokinetics of KX2-391 have been studied in more than 120 patients in both solid and liquid tumors. A study of KX2-391 in combination with paclitaxel is currently being conducted in South Korea and sponsored through the collaboration with Hanmi Pharmaceuticals. Dr. Wing Kai Chan, Head of Clinical Operations for Asia Pacific for Kinex, said, "The ability to develop the new topical formulation of KX2-391 for hyper-proliferative skin diseases shows how Kinex is effectively building up its pipeline of drug candidates. I look forward to working with our partner PharmaEssentia to initiate the clinical trials of KX2-391 Ointment for psoriasis, and oral KX2-391 for leukemia and other oncology indications."
About Kinex: Kinex Pharmaceuticals is a Buffalo, New York based company with additional offices in Cranford, New Jersey, Taipei, Taiwan and Hong Kong. In addition to KX2-391 Ointment, the Company has four oral oncology drugs currently in clinical stages of development. Two programs have emerged from collaboration with Hanmi Pharmaceuticals on the Orascovery Platform including Oraxol (oral paclitaxel) and Oratecan (oral irinotecan). Internally discovered compounds include KX2-391 for oncology indications and KX2-361 for glioma which was also been granted orphan drug designation. Kinex is developing its pipeline globally through partnerships with: Hanmi Pharmaceuticals (Seoul, Korea), Xiangxue Pharmaceuticals (Guangzhou, China), PharmaEssentia Corporation (Taipei, Taiwan) and Zenith Technology (Dunedin, New Zealand). Kinex is also working on additional Orascovery-based drug candidates in collaboration with Hanmi Pharmaceuticals and some of the projects received research funding support from the Innovation and Technology Commission (ITC) of the Government of the Hong Kong Special Administrative Region through Kinex Pharmaceuticals (HK) Limited* and the support of the Department of Applied Biology and Chemical Technology of the Hong Kong PolyTechnic University.
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