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ProDermX: Topical Protector Against Radiation Dermatitis

ProDermX：针对放射性皮炎的局部保护剂

基本信息

批准号：
6583858
负责人：
WILLIAM E FAHL
金额：
$ 9.75万
依托单位：
PROCERTUS BIOPHARM, INC.
依托单位国家：
美国
项目类别：
财政年份：
2003
资助国家：
美国
起止时间：
2003-08-13 至 2004-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6583858
关键词：
DNA damage cell cycle chemoprevention cytoprotection drug delivery systems drug design /synthesis /production laboratory rat nonhuman therapy evaluation polyamines radioprotective agents stem cells topical drug application

项目摘要

DESCRIPTION (provided by applicant): Several recent clinical studies have described the side effect of radiation-induced dermatitis that occurs in the majority of cancer patients who receive radiotherapy. These same studies also report the lack of effective agents to prevent or treat this dermatitis. In some of these patients, the side effects are severe enough that they withdraw from further radiotherapy. Nonetheless, radiotherapy remains a standard and essential part of cancer treatment and cure. ProCertus has developed a topically applied treatment to diminish or eliminate the dermatitis associated with radiotherapy. In current animal proof of concept studies, ProCertus has shown a >90% reduction in radiation-induced dermatitis by pretreating animals with ProDermX, which is currently a research stage human pharmaceutical. This technology consists of a carrier vehicle that delivers a single active agent to the stem cells of the epidermis. The active agent, a proprietary "chemoprotective polyamine," physically protects cellular DNA while also inducing a G1 phase, cell cycle block. This strategy enables the stem cells within the stratum germinativum of the epidermis to survive the radiation exposure, and to continue to replenish the outer layers of the skin and thus maintain a patent skin surface. Though ProCertus scientists have already carried this product through animal model proof of concept, there remain several biological and pharmacological questions that need to be answered before human studies can be initiated. Three Specific Aims have been designed to address and answer these questions during the course of this Phase I SBIR project, which will then enable initial studies in human populations in future research.

描述（由申请人提供）：最近的几项临床研究描述了大多数接受放射治疗的癌症患者发生的放射性皮炎的副作用。这些相同的研究还报告缺乏有效的药物来预防或治疗这种皮炎。在其中一些患者中，副作用严重到足以使他们退出进一步的放射治疗。尽管如此，放射治疗仍然是癌症治疗和治愈的标准和重要组成部分。ProCertus开发了一种局部应用治疗，以减少或消除与放疗相关的皮炎。在目前的动物概念验证研究中，ProCertus已显示，通过使用ProDermX（目前处于研究阶段的人类药物）预处理动物，辐射诱导的皮炎减少>90%。该技术由将单一活性剂递送至表皮干细胞的载体媒介物组成。活性剂是一种专有的“化学保护性多胺”，在物理上保护细胞DNA，同时也诱导G1期细胞周期阻滞。这种策略使表皮的生发层内的干细胞能够在辐射暴露中存活，并继续补充皮肤的外层，从而保持皮肤表面的通畅。虽然ProCertus科学家已经通过动物模型验证了该产品的概念，但在启动人体研究之前，仍有几个生物学和药理学问题需要回答。在第一阶段SBIR项目过程中，设计了三个具体目标来解决和回答这些问题，这将使未来的研究能够在人群中进行初步研究。