血液學權威背書！藥華藥腫瘤新藥完成歐3期收案 鉅亨網記者張旭宏 台北2015-04-20 09:06 興櫃新藥廠藥華醫藥(6446-TW)舉辦「骨髓增生性腫瘤」研討會，會中邀請全球血液學權威Kiladjian博士，他表示，新一代干擾素將是治療MPN新標準，目前藥華藥的P1101完成PV歐洲三期臨床收案，有機會成為第一線治療藥物。Jean-Jacques Kiladjian指出，許多的國際臨床研究皆證實甲型聚乙二醇干擾素(PEG-IFN-α)是有利於治療MPN患者，近年主導的一項臨床研究數據顯示，P1101(AOP2014)新一代改良型長效型干擾素(PEG-IFNα- 2b)，在真性紅血球增生症(PV)患者的JAK2突變細胞株上呈現抗增生效果，不但可減少紅血球系細胞聚落數目，可有效抑制JAK2突變的造血細胞，能特別針對JAK2V617F基因突變陽性細胞加以消滅，且不傷及其他正常細胞，P1101用於治療PV是具有臨床療效且低毒性。 Jean-Jacques Kiladjian醫學博士目前任職於法國聖路易斯(Saint-Louis)醫院臨床研究中心，長期致力於骨髓增生性疾病(myeloproliferative disorder)、骨髓化生不良症候群(myelodysplastic syndrome)的臨床研究與治療，在美國血液學年會與各大醫學期刊上發表過無數論文，也曾參與過Incyte旗下PV新藥Jakafi的臨床研究，在MPN疾病領域具國際權威地位。Jean-Jacques Kiladjian表示，現有的治療方式並沒有顯著效果，使得近年採用干擾素(IFNα)治療慢性骨髓性白血病(CML)、血小板增生症(ET)、全身性肥大細胞增生症、嗜酸性細胞增多綜合症，以及費城染色體陰性骨髓增生性腫瘤(MPN)等惡性血液疾病的臨床試驗有逐漸增多趨勢，其中也包括藥華醫藥的臨床研究在內。Jean-Jacques Kiladjian博士的研究結果與國際臨床經驗觀察，與藥華醫藥目前執行P1101用於治療PV所顯示的臨床療效證據相符。藥華醫藥表示，P1101已完成歐洲三期臨床試驗收案，由於採開放式設計，一旦療程結束後即可確認效果，依目前AOP公司提供的資料顯示，P1101為每2周注射一次，P1101有可能成為血液增生疾病的第一線治療藥物。
A Randomized, Open-label, Multicenter, Controlled, Parallel Arm, Phase III Study Assessing the Efficacy and Safety of AOP2014 vs. Hydroxyurea in Patients With Polycythemia Vera Phase III study to compare the efficacy and safety of the novel monopegylated interferon alpha 2b AOP2014 versus Hydroxyurea (the current licensed therapy for this disease). One year treatment of patients with polycythemia vera. The hypothesis is that AOP2014 is superior to HU to achieve response rates measured after one year. Response is measured as normalisation of key lab parameters as well as normalized spleen size.
Estimated Enrollment: 256
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Responsible Party: AOP Orphan Pharmaceuticals AG
Study First Received: September 6, 2013
Last Updated: April 17, 2015
Health Authority: Austria: Austrian Medicines and Medical Devices Agency/Bulgaria: Ministry of Health/Czech Republic: State Institute for Drug Control/France: Agence Nationale de Sécurité du Médicament et des produits de santé/Germany: Federal Institute for Drugs and Medical Devices/Hungary: Ministry of Health, Social and Family Affairs/Italy: Ministry of Health/Poland: Ministry of Health/Romania: National Agency for Medicines and Medical Devices/Russia: Ministry of Health of the Russian Federation/Slovakia: State Institute for Drug Control/Spain: Ministry of Health/Ukraine: Ministry of Health
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