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.

冠状病毒大流行使压力性损伤成为人们关注的焦点。患者和卫生专业人员中压力性损伤的发生率急剧上升。这是由于全球 ICU 入院人数增加、机械通气需求大幅增加、俯卧位治疗急性呼吸窘迫综合征的使用增加以及个人防护设备和医疗器械的使用急剧增加。 易受机会性多重耐药感染 (MDR) 影响的压力性损伤可导致治疗延误、败血症、骨髓炎、截肢和死亡。经常有报道称，对于位于 COVID-19 患者血管化受限区域的感染的 MDR 菌株，抗生素治疗失败或疗效降低。 抗生素疗法的替代或补充是使用噬菌体来针对细菌感染。噬菌体在人体中的施用需要适当的递送系统。 在生理条件下生产稳定、无毒的喷雾构成了将噬菌体安全应用于临床的新方法。为此，我们将噬菌体混合物封装在基于氨基酸的可生物降解聚合物中，以延长噬菌体在损伤部位的递送时间。 2020年与 FDA 举行了 IND 前会议，为 Phagelux 产品 PL-03-BM 建立全面的 CMC 和临床计划。在这个合作研究项目中，我们的目标是表征微胶囊化噬菌体的工程和临床前批次，以澄清与 CMC 相关的问题，并进一步推进用于治疗和预防压疮伤口感染的整体药物开发计划 PL-03-BM。