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ÃĵØÂåÃĪº·s«¬¤zÂZ¯ÀP1101¡]interferon alfa-2b¡^¦A¶Ç±¶³ø¡I¤@½g¥Ñ¼Ú¬w¦h°êÂå®vÁp¦W¼¶¼gªº¸ÕÅç³ø§i¡A2015/10/08¦A«×Àò¬ü°ê¦å²GÂå¾Ç¤ë¥Z¡]BLOOD JOURNAL¡^µn¸ü³ø¾É¡A¤å¤¤«ü¯u©Ê¬õ¦å²y¼W¥Í¯g¡]PV¡^±wªÌ¦b±µ¨üP1101¸ÕÅç«á¡AªvÀø®ÄªG°ª¹F90%¡]§t47%ªv¡²v¤Î43%§ïµ½²v¡^¡A¯à¦³®Ä§í¨îJAK2­P¯f°ò¦]¡A¦Ó¥B¥u»Ý­n¨C¨â¶gª`®g¤@¾¯¡AÃĮīù¤[¥B¬r©Ê·¥§C¡A¥i¤j´T¼W¥[¯f±wªº­@¨ü«×¡C

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­ì¤å¼ÐÃD¡GRopeginterferon alfa-2b, a novel IFN£\-2b, induces high response rates with low toxicity in patients with polycythemia vera

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Heinz Gisslinger1, Oleh Zagrijtschuk2, Veronika Buxhofer-Ausch3,4, Josef Thaler5, Ernst Schloegl6, Guenther A. Gastl7, Dominik Wolf7,8, Robert Kralovics1,9, Bettina Gisslinger1, Karin Strecker3, Alexander Egle10, Thomas Melchardt10, Sonja Burgstaller5, Ella Willenbacher7, Martin Schalling1, Nicole C. Them9, Pavla Kadlecova11, Christoph Klade2, and Richard Greil10

Key Points

¡E The novel IFN£\-2b, ropeginterferon alfa-2b, administered once every 2 weeks has low toxicity and induces high and sustained response rates in polycythemia vera patients.

¡E Ropeginterferon alfa-2b induces significant partial and complete molecular response rates, as reflected by reduction of JAK2 allelic burden.

Abstract

In this prospective, open-label, multicenter phase 1/2 dose escalation study, we used a next-generation, mono-pegylated interferon (IFN) £\-2b isoform, ropeginterferon alfa-2b. The unique feature of ropeginterferon alfa-2b is a longer elimination half-life, which allows administration every 2 weeks. We present data from 51 polycythemia vera patients. The main goal was to define the maximum tolerated dose and to assess safety and efficacy. A dose range of 50 to 540 £gg was tested without the appearance of dose-limiting toxicities. All drug-related adverse events were known toxicities associated with IFN-£\. The cumulative overall response rate was 90%, comprising complete response in 47% and partial response in 43% of patients; the best individual molecular response level was a complete response in 21% of patients and partial response in 47%. Notably, we did not observe any correlation between the dose level and the response rate or response duration, suggesting that already low levels of ropeginterferon alfa-2b are sufficient to induce significant hematologic and molecular responses. These data suggest promising efficacy and safety of ropeginterferon alfa-2b and support the development of the drug in a randomized phase 3 clinical trial. The study was disclosed at www.clinicaltrials.gov as #NCT01193699 before including the first patient.

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June 29, 2014

Gilead Sciences Inc.

Thoughts On EM Sovaldi

Al Borsa newspaper suggests 200k/yr (1M total)Egyptian patients could be treated with Sovaldi: 10 local manufacturers have been granted authority to produce the drug. As previously disclosed Sovaldi will cost 2,200 Egyptian pounds (EGP)/mo ($308); hwr, newly

disclosed is that outside of gov¡¦t centers the price will be EGP14,900 ($2,083). The gov¡¦t plans to......

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