GLP Pre clinical Rodent Studies of ZAG as an Anti-obesity, Anti-Diabetic Therapeu

ZAG 作为抗肥胖、抗糖尿病疗法的 GLP 临床前啮齿动物研究

• 批准号: 8001163
• 负责人: PHILIP SPEROS
• 金额: $ 18.2万
• 依托单位: HALSA PHARMACEUTICALS, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-10 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8001163
• 关键词: Adipocytes; Adipose tissue; American; Animals; Anions; Biological; Body Weight decreased; Body fat; Cell Culture Techniques; Cell Line; Chromatography; Clinical Trials; Data; Data Set; Developed Countries; Diabetes Mellitus; Dose; Ensure; Epidemic; Foundations; Glycoproteins; Goals; Health Care Costs; Histopathology; Human; In Vitro; Intellectual Property; Isoelectric Focusing; Legal patent; Licensing; Lipid Mobilization; Lipolysis; Mammalian Cell; Marketing; Materials Testing; Measures; Metabolic Diseases; Molecular; Obesity; Organ; Overweight; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Physiological; Preparation; Process; Property Rights; Proteins; Protocols documentation; Rattus; Recombinants; Relative (related person); Rodent; Safety; Sampling; Small Business Innovation Research Grant; Symptoms; Therapeutic; Therapeutic Agents; Toxicokinetics; Toxicology; Transfection; Work; Zinc; combat; cost; design; diabetic; drug development; gel electrophoresis; human subject; in vivo; novel; phase 1 study; pre-clinical; preclinical study; programs; public health relevance; response; therapeutic development

DESCRIPTION (provided by applicant): Halsa has acquired the exclusive intellectual property rights to ZAG, a material naturally found in humans, which induces immediate and substantial depletion of body fat as well as control of diabetic symptoms. A growing set of evidence shows that this therapeutic works in depleting body fat. Over 65% of Americans are overweight or obese, the costs of these conditions is estimated as $150 billion (half in actual health care costs), and the market for an effective prescription weight-loss therapeutic is estimated at $18 billion annually. Halsa has assembled a world-class team with exact domain expertise in pharmaceutical drug development. This project will lay the foundation for ZAG to enter full preclinical trials in preparation of an IND filing with the FDA, and subsequent clinical trials. This SBIR Phase I project will result in exploratory GLP toxicological studies in rats, a critical step in understanding possible liabilities for this promising therapeutic agent. The three specific aims of this project are: manufacture of the biologic agent, determination of its potency and toxicology studies including histopathology. PUBLIC HEALTH RELEVANCE: Obesity and overweight are epidemic, dangerous, expensive and largely untreated. Halsa is developing a biological drug, ZAG, a material naturally found in humans, which induces immediate and substantial depletion of body fat and also controls symptoms of diabetes. This therapeutic candidate has the potential to treat the nearly 200 million Americans afflicted with these deleterious metabolic diseases.

描述（由申请人提供）：Halsa获得了ZAG的独家知识产权，ZAG是一种天然存在于人体中的物质，可以立即大量消耗身体脂肪，并控制糖尿病症状。越来越多的证据表明，这种疗法在消耗体内脂肪方面起作用。超过65%的美国人超重或肥胖，这些疾病的成本估计为1500亿美元（一半是实际的医疗费用），有效的处方减肥治疗的市场估计每年为180亿美元。哈尔萨组建了一支世界级的团队，在药物开发方面拥有确切的专业知识。该项目将为ZAG进入完整的临床前试验，准备向FDA提交IND申请以及随后的临床试验奠定基础。这个SBIR一期项目将在大鼠身上进行探索性GLP毒理学研究，这是了解这种有前途的治疗药物可能的责任的关键一步。该项目的三个具体目标是：生物制剂的制造，其效力的确定和包括组织病理学在内的毒理学研究。