新药研发资讯分享 心存希望 8/2017
节录了主要部分,用翻译器翻译了一下,与大家分享最新的药物发展,资料来源:pdsa.org/component/k2/item/1431-prtx-100-data.html
businesswire.com/news/home/20170801005140/en/Protalex-Completes-Data-Analysis-Dose-Cohort-U.S.
Protalex Completes Data Analysis of Second Dose Cohort of U.S. Phase 1/2 Study of PRTX-100 in ITP
Protalex完成了ITP美国Phase 1/2研究PRTX-100的第二剂量队列的数据分析
August 01, 2017 08:30 AM Eastern Daylight Time
About PRTX-100
PRTX-100, a new generation immunomodulatory therapy, is a highly purified form of SpA, an immunomodulatory protein known to modify aspects of the human immune system. PRTX-100 has the ability, at very low concentrations, to bind to human B-lymphocytes and macrophages and to modulate immune processes. Pre-clinical data indicate that PRTX-100 may have the potential to treat ITP by reducing the immune-mediated destruction of the platelets. The two most recently approved drugs used to treat ITP, Nplate® (romiplostin) and Promacta®/Revolade™ (eltrombopag) both increase the production of platelets but do not appear to affect the underlying platelet destruction process. The safety, tolerability, and pharmacokinetics of PRTX-100 have been characterized in five clinical studies and was recently granted Orphan Drug Designation in the U.S. and Europe for the treatment of ITP. In two Phase 1b clinical trials in adult patients with active Rheumatoid Arthritis (RA), PRTX-100 was generally safe and well tolerated at all dose levels, and at certain higher doses, more patients showed improvement in measures of RA disease activity than did patients at the lower dose or placebo cohorts. PRTX-100 is given as a short intravenous infusion.
2017年8月1日08:30东部夏令时间
关于PRTX-100
新一代免疫调节治疗PRTX-100是一种高度纯化形式的SpA，已知可以修饰人免疫系统方面的免疫调节蛋白。 PRTX-100具有以非常低的浓度结合人B淋巴细胞和巨噬细胞并调节免疫过程的能力。临床前数据表明，PRTX-100可能具有通过减少免疫介导的血小板破坏来治疗ITP的潜力。用于治疗ITP，Nplate®（romiplostin）和Promacta®/ Revolade™（eltrombopag）的两种最近批准的药物都会增加血小板的产生，但似乎不会影响基础的血小板破坏过程。 PRTX-100的安全性，耐受性和药代动力学已经在五项临床研究中得到表征，最近在美国和欧洲授予了用于治疗ITP的孤儿药物指定。在具有活动性类风湿关节炎（RA）的成年患者的两个阶段1b临床试验中，PRTX-100在所有剂量水平下通常是安全的并且耐受性良好，并且在某些较高剂量下，更多的患者比RA患者显示出RA病变活动的改善在较低剂量或安慰剂队列。给予PRTX-100作为短暂的静脉滴注.
福音啊
还有一个RIGEL 公司在研制的药FOSTAMATINIB，希望能造福人类 evenblue 发表于 2018-1-5 09:52
还有一个RIGEL 公司在研制的药FOSTAMATINIB，希望能造福人类
今年四月份,FDA可能会批准上市 希望可以代替目前的大剂量激素疗法，太痛苦了
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