Primate Model for Pharmaceutical Development

用于药物开发的灵长类动物模型

基本信息

批准号：
7433206
负责人：
You-Tang Shen
金额：
$ 38.25万
依托单位：
VASADE BIOSCIENCES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-09-05 至 2009-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7433206
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

项目摘要

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展有望为治疗人类疾病提供令人兴奋的新策略。关于临床前研究数据的一个重要问题是，结果可能无法预测未来的临床结果。动物和人类之间存在解剖学，生理和病理过程的许多差异。我们的STTR提案的目的是在猴子中建立一种新颖的临床前研究模型。这种长期具有仪器，有意识的猴子模型将密切模仿人类患者观察到的充血性心力衰竭的过程，这是美国死亡率和发病率的主要原因。显然，该模型不仅将有助于阐明心脏病的机制，而且还将为评估人类潜在的新干预措施提供系统。还可以进行药物动力学和药代动力学研究以及安全性和毒理学评估。 I期STTR项目证明了以下假设：将心肌梗塞（MI）与快速心室起搏相结合可以诱导慢性心肌缺血，从而导致仪器，有意识的猴子的最终阶段心力衰竭。 II期研究将进一步表征该模型，尤其是关于心肌恢复现象的现象，并可能导致对心脏细胞存活和死亡中涉及的基因的鉴定。为了实现II期目标，该研究将使用猴子的最先进，生理，基因组和病理实验方法。该第二阶段项目将使新的企业Vasade Biosciences能够为生物技术和制药公司的早期临床前需求提供宝贵的商业合同研究服务。