Glycosaminoglycans to Treat and Prevent Radiation-Induced Oral Mucositis

糖胺聚糖治疗和预防放射性口腔粘膜炎

基本信息

  • 批准号:
    10675674
  • 负责人:
  • 金额:
    $ 20.04万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2021
  • 资助国家:
    美国
  • 起止时间:
    2021-09-20 至 2025-02-28
  • 项目状态:
    未结题

项目摘要

Project Summary/Abstract Oral mucositis is a devastatingly painful inflammatory disease that frequently develops during cancer therapy and affects half a million Americans. The accompanying pain is so severe that patients often require narcotic pain medicines. The clinical manifestations are ulcers in the mouth and gastrointestinal tract, which are exacerbated by opportunistic infections. Many patients also suffer from dry mouth causing difficulty in swallowing because of the decreased salivary gland function. As a result, these patients often need feeding tubes which interrupts their cancer treatment. The financial burden to the patient is staggeringly high, costing an additional $17,000 to $40,000 for each patient. Preventing oral mucositis will greatly enhance the cancer therapy as well as the wellness of the patients. GlycoMira's lead candidate, GM-1111, is a new class of anti- inflammatory drugs that modulate an overactive innate immune system when administered via once daily subcutaneous injection. The SBIR Phase I and II study results demonstrate its powerful efficacy in reducing the severity and the occurrence of the disease in radiation-induced oral mucositis models: GM-1111 reduced tissue ulceration and inflammation in the tongue. Histologically, oral tissues from the GM-1111 treated group showed markedly reduced damages in the epithelium with mild infiltration of leukocytes, thicker mucosal layers and prevention of mucous glandular alterations compared to the tissues from vehicle treated controls. Biochemical and gene expression analyses of the diseased tissues revealed increased expression of Toll-like receptors, NLRP3 inflammasome as well as their downstream pro-inflammatory cytokines all of which were reduced with GM-1111 treatment. Overall, the data suggest that GM-1111 has substantial potential to reduce oral mucositis in humans. GlycoMira also manufactured cGMP compliant GM-1111 and generated its manufacturing specifications. To further develop a commercially viable therapeutic for oral mucositis, we propose studies that will be used for the Investigative New Drug (IND) application to the FDA for clinical trials. The objectives are to (1) delineate the safety profiles of GM-1111 in nonclinical studies and (2) manufacture clinical trial ready sterile drug product (aseptic fill/finish and labeling/packaging) and test its stability. The results of the proposed research will lead the drug development to the clinical stage through IND application and propel the commercialization of the drug to the patients suffering from this devastating disease.
项目概要/摘要 口腔粘膜炎是一种极其痛苦的炎症性疾病,在癌症治疗期间经常发生 并影响了五十万美国人。伴随的疼痛非常严重,患者经常需要麻醉剂 止痛药。临床表现为口腔和胃肠道溃疡, 机会性感染会加剧。许多患者还患有口干症,导致进食困难 由于唾液腺功能下降而导致吞咽困难。因此,这些患者经常需要喂食 中断他们的癌症治疗的管子。患者的经济负担之大令人震惊 每位患者额外支付 17,000 至 40,000 美元。预防口腔粘膜炎将大大增强癌症的发生 治疗以及患者的健康。 GlycoMira 的主要候选药物 GM-1111 是一类新型抗- 每日一次服用可调节过度活跃的先天免疫系统的炎症药物 皮下注射。 SBIR I 期和 II 期研究结果证明了其在减少 放射性口腔粘膜炎模型中疾病的严重程度和发生率:GM-1111 降低 舌头组织溃疡和炎症。组织学上,GM-1111治疗组的口腔组织 上皮损伤明显减少,白细胞轻度浸润,粘膜层增厚 与媒介物处理的对照组织相比,预防粘液腺改变。 患病组织的生化和基因表达分析显示 Toll 样表达增加 受体、NLRP3 炎性体及其下游促炎细胞因子 GM-1111 治疗可减少。总体而言,数据表明 GM-1111 具有巨大的潜力来减少 人类口腔粘膜炎。 GlycoMira 还生产了符合 cGMP 的 GM-1111 并生成了其 制造规格。为了进一步开发商业上可行的口腔粘膜炎治疗方法,我们 提出将用于向 FDA 申请新药研究 (IND) 进行临床试验的研究。 目标是 (1) 描绘 GM-1111 在非临床研究中的安全性概况以及 (2) 生产 准备进行临床试验的无菌药品(无菌灌装/完成和标签/包装)并测试其稳定性。这 拟议研究的结果将通过IND申请引导药物开发进入临床阶段 并推动该药物的商业化,帮助患有这种毁灭性疾病的患者。

项目成果

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Justin Rodney Savage其他文献

Justin Rodney Savage的其他文献

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{{ truncateString('Justin Rodney Savage', 18)}}的其他基金

Glycosaminoglycans to Treat and Prevent Radiation-Induced Oral Mucositis
糖胺聚糖治疗和预防放射性口腔粘膜炎
  • 批准号:
    10491258
  • 财政年份:
    2021
  • 资助金额:
    $ 20.04万
  • 项目类别:
A Novel Glycosaminoglycan-Based Therapeutic for Chronic Rhinosinusitis
一种基于糖胺聚糖的慢性鼻窦炎治疗方法
  • 批准号:
    10437945
  • 财政年份:
    2016
  • 资助金额:
    $ 20.04万
  • 项目类别:

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