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美國PolyMedix
美國PolyMedix公司是一家新興的生物技術(shù)公司,利用仿生學開發(fā)感染性疾病和急性心血管疾病的急救產(chǎn)品
2009年6月5日,PolyMedix公司開發(fā)研究了一種治療感染性疾病的新型抗生素化合物PMX-30063,該公司主要開發(fā)治療感染性疾病和急性心血管疾患的藥物。PMX-30063是一種全新的抗生素藥物,它以其獨特的作用方式可能會對耐藥細菌起作用。
這項臨床試驗將在幾天內(nèi)重復給藥來評估PMX-30063的安全性,健康志愿受試者將每隔12h,24h,48h接受5~10的劑量。先前的試驗數(shù)據(jù)顯示,每日一次服用該藥也能治療感染,但此次試驗主要比較每日一次與每日兩次或兩日一次的療效,以此評價該藥的最佳有效劑量。假如公司能夠順利完成這項臨床試驗,并且資金到位的情況下,PolyMedix公司打算繼續(xù)進行2期臨床試驗。
“能繼續(xù)進行PMX-30063的開發(fā)與臨床研究,我們都感到非常興奮” PolyMedix公司的總裁Nicho說到,“我們堅信這種新型的抗生素是治療感染性疾病的一個突破,他是第一個開發(fā)用來治療全身感染疾病的小分子制劑,也是第一個能治療細菌耐藥的藥物。我們公司首先把這種藥物帶入臨床試驗讓我們非常自豪。”
2008年11月10日,PolyMedix公司宣布了PMX-30063的1期臨床試驗結(jié)果。該試驗達到了預期的試驗目的,其結(jié)果提示每日服用該藥能夠達到臨床治療感染的要求,且副作用較小。
PMX-30063簡介:
與其他抗生素藥物不同,該藥是一種人工合成的宿主防御蛋白,PolyMedix公司相信該藥是第一個進入臨床的小分子抗感染制劑。它是模仿宿主防御蛋白而設計的,但它是人工合成的,沒有肽段,小分子結(jié)構(gòu)。PMX-30063能直接瓦解細菌的細胞膜,因此,細菌對該藥的耐受性不大,不容易產(chǎn)生臨床耐藥性。
PolyMedix is a biotechnology company that is developing novel, synthetic small molecule compounds that mimic the activity of large natural proteins - compounds called biomimetics. We focus on creating new therapeutic drugs to meet major unmet medical needs for treatment of serious, life threatening, acute disorders. Our initial programs involve new drug treatments for infectious diseases, and acute cardiovascular bleeding disorders. Using our proprietary computational drug design technology, we have created novel antibiotic and heptagonist drug compounds, and plan to file Investigational New Drug (IND) applications with the U.S. Food and Drug Administration (FDA) for each of these product candidates during the first quarter of 2008.
Our product candidates have been rationally selected because we believe they represent attractive medical and commercial opportunities and are characterized by:
Major unmet medical needs;
Relatively short clinical trials to demonstrate proof of principle of clinical utility;
Indications that may allow for accelerated regulatory review or development paths;
Objective clinical endpoints and assessment criteria; and
Availability of animal models that are often considered predictive of potential human activity.