PBI Manufacture Core

PBI制造核心

• 批准号: 7284602
• 负责人: Kenneth Hadlock
• 金额: $ 9.04万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-01 至 2011-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7284602
• 关键词: AIDS Dementia Complex; Anabolism; Animal Model; Animals; Antineoplastic Agents; Archives; Biological; Biological Assay; Biotechnology; Cities; Class; Clinical; Clinical Investigator; Clinical Trials; Commit; Comparative Study; Consult; Consultations; Contracts; Development; Documentation; Drug Formulations; Drug Stability; Ensure; Generations; Guanosine Monophosphate; HIV; Human; In Vitro; Investigational Drugs; Investigational New Drug Application; Joints; Label; Lead; Lymphoma; Macaca mulatta; Maintenance; Malignant Neoplasms; Modeling; Monitoring Clinical Trials; Pamphlets; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Phase I Clinical Trials; Phase I/II Trial; Polyamines; Preparation; Production; Program Research Project Grants; Quality Control; Recording of previous events; Records; Regulatory Affairs; Research Personnel; Resistance; Rights; Running; SIV; SIV encephalitis; Sterility; Supervision; Syndrome; Testing; Time; Toxicology; United States Food and Drug Administration; United States National Institutes of Health; Update; Vial device; Work; Writing; analog; base; chemotherapy; concept; cost; drug development; experience; human subject; inhibitor/antagonist; manufacturing process; nervous system disorder; performance site; programs; quality assurance; research clinical testing; small molecule

This program project envisions running two small proof of concept phase I clinical trials in human subjects. To facilitate the work of this program project grant, Pathologica will be responsible for all aspects of the manufacture, quality control, and quality assurance required to produce an investigational new drug. This component includes, the manufacture of the compound(s), packaging of the drug(s), stability testing, production of clinical investigator brochures, and filing of the INDs for both trials. The first trial is envisioned to involve the polyamine biosynthesis inhibitor PA-001 in the setting of HIV associated dementia and related syndromes. PA-001 has shown excellent activity against SIV encephalitis in rhesus macaque model (see Project 2: Animal model studies for more details). The compound for the second trial will be chosen based on the results of the in vitro and animal studies performed during the first two years of the program project, but will also be a polyamine biosynthesis inhibitor. Pathologica LLC is fortunate to have rights to evaluate and commercialize many PBIs including the polyamine analog CG47, and the PBI manufacture core will ensure that sufficient quantity and quality of these polyamine analogs will be available for comparative studies with PA-001 as described more fully in Projects 1 and 2 of this program project grant. To provide the drugs Pathologica will be assisted by Dr Fredrick Johnson, who has more than 20 years of experience in the manufacture and quality assurance testing of both small molecule and biological pharmaceutical products.

该计划项目设想在人类受试者中进行两项小型概念验证一期临床试验。 为了促进该计划项目拨款的工作，Pathologica 将负责该计划的所有方面 生产研究性新药所需的生产、质量控制和质量保证。这 组成部分包括化合物的制造、药物的包装、稳定性测试、 制作临床研究者手册，并提交两项试验的 IND。预计首次审判 将多胺生物合成抑制剂 PA-001 应用于治疗 HIV 相关痴呆症和相关疾病 综合症。 PA-001 在恒河猴模型中表现出优异的抗 SIV 脑炎活性（参见 项目 2：动物模型研究（了解更多详情）。第二次试验的化合物将根据 根据该计划项目头两年进行的体外和动物研究的结果， 但也将是多胺生物合成抑制剂。 Pathologica LLC 有幸拥有评估权 并将包括多胺类似物CG47在内的许多PBI商业化，PBI制造核心将 确保这些多胺类似物的数量和质量足以用于比较 使用 PA-001 进行研究，如本计划项目拨款的项目 1 和 2 中更详细地描述。提供 病理学药物将由 Fredrick Johnson 博士协助，他在病理学领域拥有 20 多年的经验 小分子和生物制药产品的制造和质量保证测试。