EVP-ABD for MRI of Liver Disease

描述(由申请人提供)：肝脏疾病仍然是准确鉴别诊断的主要挑战。几种不同类型的病变常见于肝脏。肝脏是许多恶性肿瘤转移扩散的主要病灶。通常，良性病变和恶性病变并存。明确区分每种病变类型对于最佳治疗计划和后续治疗至关重要。尽管技术进步，但仍有大量病变被遗漏或误诊。显然，仍有必要改进成像技术，以最大限度地发挥快速发展的诊断技术的能力。使用磁共振成像(MRI)诊断肝脏病理仍然受到缺乏肝脏特异性显像剂的限制，该显像剂具有明确的血管时相。Eagle Vision制药公司正在开发一种基于锰的核磁共振试剂EVP-ABD，以满足改善肝脏和腹部疾病鉴别诊断的需求。研究表明，EVP-ABD独特的磁性和动力学特性为血管和肝脏提供了高水平的增强。更多的研究已经证明了一种类似于市场上销售的药物的安全性。这些特征应能克服MRI在肝脏检查中的局限性，并能更好地区分各种恶性和良性病变。这种潜力将在第二阶段进行评估。

DESCRIPTION (provided by applicant): Liver disease remains a major challenge for accurate differential diagnosis. Several different types of lesions are commonly found in the liver. Liver is a prime focus for metastatic extension of numerous malignancies. Often, both benign and malignant lesions co-exist. It is critical for optimal treatment planning and follow-up to clearly differentiate each lesion type. Despite advances in technology, a large lumber of lesions are missed or incorrectly diagnosed. There remains a clear need for improved imaging 3gents that maximize the capabilities of rapidly evolving diagnostic technologies. Diagnosis of liver pathology using magnetic resonance imaging (MRI) continues to be limited by the lack of a liver-specific imaging agent with a well-defined vascular phase. Eagle Vision Pharmaceutical Corp. is developing EVP-ABD, a manganese-based MRI agent, to address unmet needs for improved differential diagnosis of liver and abdominal diseases. Studies demonstrated the unique magnetic and kinetic properties of EVP-ABD provide high levels of enhancement for both blood vessels and liver. Additional studies have demonstrated a safety profile similar to marketed agents. These features should overcome limitations to the use of MRI for liver and provide better discrimination between various malignant and benign lesions. Such potential will be assessed in Phase II.