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，这是人类自然发现的材料，可诱导体内脂肪的立即和大量耗竭以及控制糖尿病症状。越来越多的证据表明，这种治疗性在耗尽体内脂肪中起作用。超过65％的美国人超重或肥胖，这些疾病的成本估计为1.5亿美元（实际的医疗保健费用一半），有效的处方减肥治疗的市场估计为每年180亿美元。 Halsa召集了一支世界一流的团队，具有药物开发方面的精确领域专业知识。该项目将奠定ZAG进入完整临床前试验的基础，以准备与FDA一起进行IND归档以及随后的临床试验。这个SBIR I期项目将导致大鼠探索性GLP毒理学研究，这是理解这种有前途的治疗剂可能责任的关键步骤。该项目的三个特定目的是：生物制造剂的生产，确定其效力和毒理学研究，包括组织病理学。 公共卫生相关性：肥胖和超重是流行病，危险，昂贵且在很大程度上没有治疗的。 Halsa正在开发一种生物学药物ZAG，这是一种在人类中自然发现的材料，该材料诱导了体内脂肪的立即和大量消耗，还可以控制糖尿病的症状。这位治疗候选人有可能治疗遭受这些有害代谢疾病的近2亿美国人。