DEVELOPMENT OF A NEW DRUG FOR P. CARINII AND MALARIA

开发治疗卡氏疟原虫和疟疾的新药

• 批准号: 6133860
• 负责人: MAHMOUD A ELSOHLY
• 金额: $ 27.63万
• 依托单位: ELSOHLY LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-15 至 2002-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6133860
• 关键词: Macaca mulatta; Pneumocystis carinii; Pneumocystis pneumonia; Saimiri; antimalarial agents; antiprotozoal agents; chemical structure function; drug design /synthesis /production; drug screening /evaluation; high performance liquid chromatography; malaria; pharmacokinetics; quinoline

DESCRIPTION (Adapted from the application): The overall objective of this Phase II STTR application is to complete the preclinical studies for NPC 1161B, a promising new drug candidate for the treatment and prophylaxis of malaria. The drug is also very effective in animal models for the treatment or prevention of Pneumonocysis carinii (PCP) and leshmaniasis. This project is the continuation of the STTR Phase I project and a continuing collaborative effort between Elsohly Laboratories Inc., Oxford MS and The National Center for Natural Products Research of the University of MS (UM). In this Phase II application, these studies will be extended to complete the package of information necessary for the filing of the Investigational New Drug application. The objective will be accomplished through a plan of work to achieve the following specific aims: 1) Determine the physiochemical characteristics purity and stability of the GMP drug substance NPC1161B, assess compatibility of the drug with commonly used capsule formation excipients; 2) Evaluate the stereoisomers of NPC1161 (NCP1161A and NCP1161B) in primate models for relative antimalarial efficacy, toxicity, and metabolism/kinetics; 3) Develop analytical methods and a formulation of NCP1161B for clinical studies (drug product) and conduct accelerated stability studies; 4) Prepare and submit IND application. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

描述（改编自申请）：本阶段的总体目标 II STTR申请是为了完成NPC 1161B的临床前研究， 有前途的治疗和预防疟疾的新候选药物。这 该药物在动物模型中对于治疗或预防也非常有效 卡氏肺孢子虫病 (PCP) 和利什曼病。这个项目是延续 STTR 第一阶段项目以及双方的持续合作 Elsohly Laboratories Inc.、牛津 MS 和国家自然中心 密苏里大学 (UM) 的产品研究。 在本次二期申请中，这些研究将得到扩展以完成 提交试验性新药所需的信息包 应用。该目标将通过一项工作计划来实现 达到以下具体目的： 1) 测定理化指标 GMP原料药NPC1161B的特性纯度和稳定性，评估 药物与常用胶囊形成赋形剂的相容性； 2） 评估灵长类动物模型中 NPC1161（NCP1161A 和 NCP1161B）的立体异构体 相对抗疟功效、毒性和代谢/动力学； 3） 开发用于临床研究的 NCP1161B 分析方法和配方 （药品）并进行加速稳定性研究； 4）准备并提交 IND 申请。 拟议的商业应用：不可用