Pentixapharm AG Receives Orphan Drug Designation for PentixaFor in Lymphoma

Berlin and Würzburg, Germany, August 26, 2024 - Pentixapharm Holding AG announced that the European Medicines Agency (EMA) and the European Commission (EC) have granted an Orphan Drug Designation for the diagnostic tracer PentixaFor. This tracer, known as Gallium (68Ga) boclatixafortide, is used for diagnosing and staging Marginal Zone Lymphoma (MZL).

Marginal Zone Lymphoma is a type of non-Hodgkin’s Lymphoma recognized as a chronically debilitating and life-threatening condition. Pentixapharm is sponsoring a European Phase III clinical trial to evaluate PentixaFor's performance in imaging and staging MZL patients.

PentixaFor is a novel tracer for PET imaging, targeting the C-X-C receptor 4 (CXCR4), which is prevalent in MZL cells. Studies have shown that PentixaFor has high sensitivity and specificity for MZL diagnosis and staging, potentially surpassing the current [18F]FDG standard.

The European Orphan Drug Program supports the development of drugs for rare diseases (affecting fewer than 5 in 10,000 people). Benefits include EMA protocol advice, regulatory fee waivers, and potential market exclusivity for 10 years upon approval.