Safety and Efficacy of C31G for Ocular Infections

C31G 治疗眼部感染的安全性和有效性

• 批准号: 6643289
• 负责人: Richard Bax
• 金额: $ 9.95万
• 依托单位: BIOSYN, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-06-01 至 2004-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6643289
• 关键词: Chlamydia trachomatis; Neisseria gonorrhoeae; antibacterial agents; antiinfective agents; antiviral agents; bacterial disease; conjunctivitis; drug adverse effect; drug screening /evaluation; drug tolerance; eye infections; herpes simplex virus 1; laboratory rabbit; virus diseases; Chlamydia trachomatis; Neisseria gonorrhoeae; antibacterial agents; antiinfective agents; antiviral agents; bacterial disease; conjunctivitis; drug adverse effect; drug screening /evaluation; drug tolerance; eye infections; herpes simplex virus 1; laboratory rabbit; virus diseases

DESCRIPTION (provided by applicant): Bacterial and viral conjunctivitis are extremely common conditions and can result in a wide range of pathologies. There are different manifestations of disease with complications, which occur rarely; however, because the infection is so common, alternative therapies are required. A broad-spectrum non-antibiotic which covers both bacteria and viruses could have great therapeutic utility on a worldwide basis. C31G is a broadly active anti-infective compound with high potency against bacterial and viral pathogens of the eye. C31G is active through surface contact with the pathogen, making resistance development unlikely. Of particular relevance to the eye is the established activity against Chlamydia trachomatis, the leading cause of preventable blindness in the world. C31G has been extensively evaluated in four Phase I clinical studies as a topical vaginal microbicide; however, no effort has been made to evaluate this agent in the eye. Therefore, this SBIR proposes a specific collection of studies to assess the potential of C31G as a treatment for a broad range of bacterial/viral conjunctivitis. Specifically, the aims of this Phase I effort are: (1) conduct an expanded in vitro evaluation of C31G aqueous solutions against primary bacterial and viral isolates that are relevant to ophthalmic infections; (2) assess C31G aqueous solutions for safety and tolerance in the eye in established animal models; and (3) develop candidate ophthalmic formulations of C31G that are appropriate for application in the eye against conjunctivitis caused by bacterial and viral infections. This effort will be primarily conducted at Biosyn; however the animal studies will be conducted with a consortium partner, Louisiana State University Eye Center. Upon achievement of these specific aims, the lead formulation will be advanced through preclinical FDA required studies via a Phase II SBIR.

描述（由申请人提供）：细菌和病毒结膜炎是极为普遍的疾病，可能导致多种病理。疾病的表现不同，并发症很少发生。但是，由于感染是如此普遍，因此需要替代疗法。涵盖细菌和病毒的广谱非抗生素可以在全球范围内具有出色的治疗用途。 C31G是一种广泛活跃的抗感染化合物，对眼睛的细菌和病毒病原体具有很高的效力。 C31G通过与病原体的表面接触而活跃，这使得抗性发展不可能。与眼睛特别相关的是针对沙眼衣原体的既定活动，这是世界上可预防失明的主要原因。 C31G已在四​​期临床研究中进行了广泛的评估，作为局部阴道菌心。但是，没有努力在眼中评估该代理。因此，该SBIR提出了一项特定的研究集合，以评估C31G作为广泛细菌/病毒结膜炎的治疗的潜力。具体而言，这一第一阶段的目的是：（1）对与眼科感染相关的主要细菌和病毒分离株进行C31G水溶液的体外评估； （2）评估既定动物模型中的安全性和耐受性的C31G水溶液； （3）开发C31G的候选眼科制剂，适合于针对由细菌和病毒感染引起的结膜炎。这项工作将主要是在Biosyn进行的。但是，动物研究将与财团合作伙伴路易斯安那州立大学眼中中心进行。在实现这些特定目的后，将通过临床前FDA通过II期SBIR进行研究。