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。肝脏中常见几种不同类型的病变。肝脏是许多恶性肿瘤转移扩展的主要焦点。通常，良性和恶性病变并存。明确区分不同的病变类型，是制定最佳治疗方案和随访的关键。尽管技术进步了，但仍有大量病变被遗漏或被错误诊断。显然仍然需要改进成像试剂，以最大限度地发挥快速发展的诊断技术的能力。由于缺乏具有明确血管期的肝脏特异性显像剂，使用磁共振成像（MRI）诊断肝脏病理仍然受到限制。Eagle Vision制药公司正在开发一种锰基MRI试剂EVP-ABD，以解决肝脏和腹部疾病未被满足的鉴别诊断需求。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。进一步的研究表明其安全性与市场上销售的药物相似。这些特征应克服肝脏MRI的局限性，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.