SBIR-STTR Award

Liver disease remains a major challenge for accurate differential diagnosis. Several different types of lesions are commonly found in the liver. The 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 number of lesions are missed or incorrectly diagnosed. There remains a clear need for improved imaging agents that maximize the capabilities of the rapidly evolving diagnostic technologies. Eagle Vision Pharmaceutical Corp. (EVPC) is developing an agent that addresses unmet needs for the improved differential diagnosis for diseases of the liver and abdomen. EVP-ABD is a manganese (Mn) based magnetic resonance imaging (MRI) contrast agent designed to be taken up by hepatocytes and eliminated in the bile. The unique magnetic and kinetic properties of EVP-ABD are anticipated to provide high levels of enhancement for both the blood vessels and liver cells. This should overcome current limitations to the use of MRI for liver imaging and provide better information to discriminate between various malignant and benign lesions. This Phase I program will define the fundamental utility of EVP-ABD for liver imaging, confirming its feasibility as an improved agent. PROPOSED COMMERCIAL APPLICATIONS: The long-term goal of this research is to register EVP-ABD in the U.S. and elsewhere as a contrast agent for liver and abdominal MRI. By combining the vascular enhancement and kinetics of ECF agents with the tissue and lesion specific patterns of enhancement of hepatocellular agents, EVP- ABD should provide a more cost-effective, less invasive and more accurate diagnosis than current alternatives.

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.

Thesaurus Terms:
contrast media, diagnosis design /evaluation, liver disorder diagnosis, liver imaging /visualization /scanning, magnetic resonance imaging, manganese, technology /technique development liver cell, liver circulation, noninvasive diagnosis, pharmacokinetics bioimaging /biomedical imaging, biotechnology, laboratory rabbit, laboratory rat