Ascelia Pharma Unveils Orviglance SPARKLE Study Results at 2024 RSNA Meeting

Ascelia Pharma (STO:ACE) is a biotech company headquartered in Malmö, Sweden, that focuses on developing innovative treatments for rare oncology conditions. On December 2, 2024, the company announced the primary results from its Orviglance® phase 3 SPARKLE Study at the Radiological Society of North America (RSNA) annual conference in Chicago, the largest radiology conference in the world.

Orviglance is an oral contrast agent created specifically to enhance the visualization of focal liver lesions in patients with compromised kidney function, who are at a high risk of adverse effects from conventional gadolinium-based contrast agents. This novel agent, which includes manganese chloride tetrahydrate, aims to address these risks by offering a safer alternative.

The SPARKLE study was a multicenter, open-label clinical trial designed to evaluate the safety and diagnostic efficacy of Orviglance in patients with suspected or known focal liver lesions and severe renal impairment. The study's results demonstrated that Orviglance significantly improved the visualization of liver lesions compared to MRI scans without contrast enhancement. This enhancement is crucial for accurate diagnosis and treatment planning for patients with liver conditions.

The findings were presented by Dr. Alvin Silva, the Principal Investigator of the SPARKLE study and a Professor of Radiology at the Mayo Clinic in Phoenix, United States. His presentation was part of the Cutting-Edge Research category at the RSNA annual meeting and was scheduled for December 2, 2024, from 13:30 to 14:00 CDT.

Orviglance has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA). This designation is typically given to drugs that provide significant benefits over existing treatments for rare medical conditions. The Orviglance clinical program comprises nine studies, including the pivotal SPARKLE phase 3 trial, all of which have reported strong efficacy and safety outcomes.

Ascelia Pharma also has another drug candidate, Oncoral, in clinical development. The company aims to develop and commercialize novel drugs that meet unmet medical needs in the oncology field. By focusing on treatments for rare cancers, Ascelia Pharma is addressing a critical gap in the market and providing new hope for patients with limited therapeutic options.

The successful results of the SPARKLE study represent a significant milestone for Ascelia Pharma, demonstrating the potential of Orviglance to become a valuable diagnostic tool for patients with liver lesions and kidney impairment. The positive data from this study support the continued development and potential commercialization of Orviglance, offering a safer and more effective contrast agent for liver imaging.

Ascelia Pharma is listed on Nasdaq Stockholm under the ticker ACE. For further details about the company's projects and progress, interested parties can visit their website.

The primary results from the SPARKLE study underscore Ascelia Pharma's commitment to advancing the field of medical imaging and improving patient outcomes through innovative research and development. The company's efforts are paving the way for new diagnostic methods that can lead to better treatment decisions and ultimately improve the quality of life for patients with severe medical needs.