Primate Model for Pharmaceutical Development

用于药物开发的灵长类动物模型

• 批准号: 7273023
• 负责人: You-Tang Shen
• 金额: $ 39.36万
• 依托单位: VASADE BIOSCIENCES, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-05 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7273023
• 关键词: Address; Adverse effects; Anatomy; Animal Model; Animals; Area; Arts; Biotechnology; Blood flow; Brain; Businesses; Cardiac; Cardiovascular Agents; Cell Survival; Cessation of life; Chronic; Clinical; Clinical Trials; Congestive Heart Failure; Conscious; Coronary artery; Data; Development; Devices; Drug Kinetics; Evaluation; Failure; Funding; Funding Agency; Future; Gene Proteins; Genes; Genomics; Goals; Government; Grant; Health Services Research; Healthcare; Heart; Heart Diseases; Heart failure; Human; Hypertrophy; Implant; Incidence; Infarction; Intervention; Investigation; Kidney; Lead; Left; Legal patent; London; Measurement; Modeling; Molecular Medicine; Monkeys; Morbidity - disease rate; Motion; Myocardial; Myocardial Infarction; Myocardial Ischemia; Myocardium; Numbers; Organ; Outcome; Pathologic Processes; Patients; Performance; Peripheral; Pharmacodynamics; Pharmacologic Substance; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Physiological; Physiology; Population; Pre-Clinical Model; Primates; Process; Research; Research Contracts; Safety; Sampling; Screening procedure; Services; Small Business Technology Transfer Research; Staging; Statistically Significant; Suggestion; System; Technology; Toxicology; Transducers; Ultrasonics; Validation; Ventricular; Ventricular Remodeling; Work; artery occlusion; base; drug market; hemodynamics; human disease; indexing; instrument; man; mortality; nonhuman primate; novel; pre-clinical; pre-clinical research; pressure; prevent; programs; radioactive microsphere technique; therapeutic target; vascular bed

DESCRIPTION (provided by applicant): Advances in molecular medicine and genomic research promise to produce exciting new strategies for the treatment of human diseases. One significant concern regarding preclinical research data is that the results may not be predictive of future clinical outcomes. Many differences in anatomy, physiology and pathological processes exist between animals and humans. The goal of our STTR proposal is to set up a novel preclinical research model in monkeys. This chronically instrumented, conscious monkey model will closely mimic the process of congestive heart failure observed in human patients, which is a leading cause of mortality and morbidity in the US. Clearly, this model will help not only to elucidate the mechanisms of the heart disease, but also will provide a system for the assessment of potential new interventions in man. Pharmacodynamic and pharmacokinetic studies, as well as safety and toxicology assessments also may be performed. The Phase I STTR project proved the hypothesis that combined myocardial infarction (MI) with rapid ventricular pacing can induce chronic myocardial ischemia leading to end stage heart failure in instrumented, conscious monkeys. The Phase II study will further characterize this model, particularly regarding the phenomenon of myocardial remolding, and may lead to the identification of genes involved in cardiac cell survival and death. To achieve the phase II goals, the study will use state-of-art, physiological, genomic and pathological experimental approaches in monkeys. This Phase II project will enable the new business venture, Vasade Biosciences, to provide a valuable commercial contract research service for the early preclinical needs of biotechnology and pharmaceutical companies.

描述（由申请人提供）：分子医学和基因组研究的进步有望产生令人兴奋的治疗人类疾病的新策略。关于临床前研究数据的一个重要担忧是，结果可能无法预测未来的临床结果。动物和人类在解剖学、生理学和病理过程上存在许多差异。 我们 STTR 提案的目标是在猴子身上建立一种新颖的临床前研究模型。这种长期使用仪器、有意识的猴子模型将密切模仿在人类患者中观察到的充血性心力衰竭的过程，充血性心力衰竭是美国死亡和发病的主要原因。显然，这个模型不仅有助于阐明心脏病的机制，而且还将提供一个评估人类潜在新干预措施的系统。还可以进行药效学和药代动力学研究以及安全性和毒理学评估。 第一阶段的 STTR 项目证明了这样的假设：心肌梗死 (MI) 与快速心室起搏相结合可诱发慢性心肌缺血，导致装有仪器、意识清醒的猴子出现终末期心力衰竭。 II期研究将进一步表征该模型，特别是心肌重塑现象，并可能导致鉴定与心肌细胞存活和死亡有关的基因。 为了实现第二阶段的目标，该研究将在猴子身上使用最先进的生理学、基因组学和病理学实验方法。该二期项目将使新的企业 Vasade Biosciences 能够为生物技术和制药公司的早期临床前需求提供有价值的商业合同研究服务。