Axcellant Launches Clinical Trial for Novel Nuclear Medicine Diagnostic Agent

Key Insights

• Axcellant, a European CRO, has initiated a clinical trial in the U.S. to evaluate a new radioactive compound for diagnostic use.
• The trial will involve approximately 20 sites across the East Coast and Midwest, focusing on oncology, cardiology, and neurology.
• The FDA has reviewed and approved the clinical development plan, paving the way for manufacturing site setup and clinical center activation.

Axcellant, a Clinical Research Organization (CRO) based in Warsaw, Poland, has announced the commencement of a clinical trial to assess a novel radioactive compound with the potential to revolutionize diagnostic procedures in nuclear medicine. The study, conducted on behalf of a European client, aims to evaluate the efficacy and safety of the compound as a diagnostic agent across a range of medical disciplines.

The trial will be conducted at approximately 20 sites in the United States, primarily on the East Coast and in the Midwest. The focus will be on applications in oncology, cardiology, and neurology, areas where nuclear medicine plays a crucial role in diagnosis and treatment planning. According to Axcellant, the new diagnostic agent could impact the standard care pathway for over 20 million patients in the US and over 200 million globally.

Expert Collaboration and Regulatory Approval

"Our team's experience with nuclear agents in oncology, cardiology, and neurology has enabled us to build deep expertise in this field," said Wojciech Kula, CEO of Axcellant. "We have also engaged leading experts and Key Opinion Leaders from across the United States, including San Francisco, Houston, New York and Rochester, to support this innovative trial."

The clinical development plan and study structure have received approval from the FDA, instilling confidence in Axcellant's procedures. "The FDA agreed with the clinical development plan and structure of the study without any significant remarks, which gave us confidence in our procedures," Kula added.

Axcellant's Expertise in Nuclear Medicine

Axcellant has been operating since 2006 and has experience in conducting trials for American companies. The company's expertise extends to various stakeholders, including manufacturing transfer, central imaging labs, and MRI/PET imaging site management. With this new trial, Axcellant is poised to further solidify its position as a key player in nuclear medicine clinical research.

Investment in Clinical Trials

Clinical trials represent a substantial investment, typically ranging from $20 million to $80 million USD over a period that can extend up to 15 years. The extensive duration and financial commitment underscore the importance of partnering with experienced and dedicated organizations like Axcellant.