Polyrizon signs agreement with research organization for clinical development

Polyrizon (PLRZ) signed an agreement with a global preclinical Contract Research Organization, or CRO, an expert in biocompatibility and regulatory-compliant testing. This agreement forms part of Polyrizon’s ongoing efforts to advance its clinical development program, which also includes a recent manufacturing of GMP production of clinical trial material, successful completion of an FDA pre-submission meeting, and positive preclinical data demonstrating effective allergen-blocking performance. The CRO will conduct a comprehensive package of preclinical biocompatibility studies in accordance with ISO 10993 standards and GLP requirements. The studies are expected to commence in Q2 and represent a key milestone in Polyrizon’s potential regulatory pathway toward initiating clinical trials, which are planned to commence later this year. The preclinical program includes cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity and pyrogenicity assessments, designed to support regulatory submissions and ensure product safety prior to human studies.