Physicochemical characterization of pre-clinical samples of a bacteriophage therapy spray-on patch for the treatment of COVID-19-related pressure injury resistant infections

用于治疗 COVID-19 相关压力损伤抗性感染的噬菌体疗法喷雾贴剂的临床前样品的理化特性

• 批准号: 555079-2020
• 负责人: Yahia, LHocine
• 金额: $ 3.64万
• 依托单位: École Polytechnique de Montréal
• 依托单位国家: 加拿大
• 项目类别: Alliance Grants
• 财政年份: 2020
• 资助国家: 加拿大
• 起止时间: 2020-01-01 至 2021-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=705805
• 关键词: Physicochemical; characterization; pre; clinical; samples

The cororonavirus pandemic has brought pressure injuries into sharp focus. The incidence of pressure injuries has dramatically risen amongst patients and health professionals alike. This is due by the global increase in ICU admissions, considerable rise in the need of mechanical ventilation, increased use of prone positioning to treat acute respiratory distress syndrome, and sharp increase in the use of personal protective equipment and medical devices. Pressure injuries susceptible to opportunistic multi-drug resistant infections (MDR) can result in delayed treatment, septicemia, osteomyelitis, amputation, and death. Failure and reduced efficacy of antibiotic treatment are frequently reported for MDR strains for infections located in areas of limited vascularization in COVID-19 patients. An alternative or supplement to antibiotic therapy is the use of bacteriophages to target bacterial infections. Administration of phages in humans requires an appropriate delivery system. The production of stable, non-toxic spray under physiological conditions constitutes a novel approach for the safe translation of bacteriophages to the clinic. To this end we encapsulated the bacteriophage cocktail in amino acid-based biodegradable polymers for a prolonged delivery of phages at the site of injury. A pre-IND meeting was held with the FDA in 2020 to establish a comprehensive CMC and clinical program for Phagelux product PL-03-BM. In this collaborative research project, we aim to characterize engineering and preclinical batches of microencapsulated phages in order to clarify issues related to CMC and further the overall drug development program PL-03-BM for the treatment and prevention of pressure ulcer wound infections.

Cororonavirus大流行使压力损伤引起了鲜明的重点。在患者和卫生专业人员中，压力损伤的发生率都显着增加。这是由于ICU入院的全球增加，机械通气的需要大幅上升，易于使用易于治疗急性呼吸遇险综合症的使用以及使用个人防护设备和医疗设备的急剧增加。 容易受到机会性多药物抗性感染（MDR）敏感的压力损伤可能导致延迟治疗，败血病，骨髓炎，截肢和死亡。经常报道抗生素治疗的衰竭和抗生素治疗的疗效，用于MDR菌株在CoVID-19患者中有限血管化区域的感染。 抗生素疗法的替代或补充是使用噬菌体靶向细菌感染。人类噬菌体的管理需要适当的输送系统。 在生理条件下稳定的无毒喷雾的产生构成了一种将噬菌体安全转换为诊所的新方法。为此，我们将基于氨基酸的可生物降解聚合物中的噬菌体鸡尾酒封装，以长时间在损伤部位递送噬菌体。 2020年与FDA举行了一次预印度会议，以建立Phagelux Product PL-03-BM的全面CMC和临床计划。在这个合作研究项目中，我们旨在表征微囊化噬菌体的工程和临床前批次，以澄清与CMC相关的问题，并进一步进一步治疗和预防压力溃疡伤口感染的总体药物开发计划PL-03-BM。