美国PolyMedix
美国PolyMedix公司是一家新兴的生物技术公司,利用仿生学开发感染性疾病和急性心血管疾病的急救产品
2009年6月5日,PolyMedix公司开发研究了一种治疗感染性疾病的新型抗生素化合物PMX-30063,该公司主要开发治疗感染性疾病和急性心血管疾患的药物。PMX-30063是一种全新的抗生素药物,它以其独特的作用方式可能会对耐药细菌起作用。
这项临床试验将在几天内重复给药来评估PMX-30063的安全性,健康志愿受试者将每隔12h,24h,48h接受5~10的剂量。先前的试验数据显示,每日一次服用该药也能治疗感染,但此次试验主要比较每日一次与每日两次或两日一次的疗效,以此评价该药的最佳有效剂量。假如公司能够顺利完成这项临床试验,并且资金到位的情况下,PolyMedix公司打算继续进行2期临床试验。
“能继续进行PMX-30063的开发与临床研究,我们都感到非常兴奋” PolyMedix公司的总裁Nicho说到,“我们坚信这种新型的抗生素是治疗感染性疾病的一个突破,他是第一个开发用来治疗全身感染疾病的小分子制剂,也是第一个能治疗细菌耐药的药物。我们公司首先把这种药物带入临床试验让我们非常自豪。”
2008年11月10日,PolyMedix公司宣布了PMX-30063的1期临床试验结果。该试验达到了预期的试验目的,其结果提示每日服用该药能够达到临床治疗感染的要求,且副作用较小。
PMX-30063简介:
与其他抗生素药物不同,该药是一种人工合成的宿主防御蛋白,PolyMedix公司相信该药是第一个进入临床的小分子抗感染制剂。它是模仿宿主防御蛋白而设计的,但它是人工合成的,没有肽段,小分子结构。PMX-30063能直接瓦解细菌的细胞膜,因此,细菌对该药的耐受性不大,不容易产生临床耐药性。
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.