Archeus Technologies, a company developing radiopharmaceutical therapies for the treatment of patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ART-101, a novel receptor-based targeting small molecule that Archeus has developed for the imaging and treatment of prostate cancer. This IND clearance enables Archeus to initiate a Phase 1 clinical trial in men with metastatic castration-resistant prostate cancer (mCRPC), which is expected to start later this year.
ART-101 was discovered and developed by Reinier Hernandez, Ph.D., assistant professor of medical physics at the University of Wisconsin–Madison, with robust development support from the Wisconsin Alumni Research Foundation. The therapy targets prostate-specific membrane antigen (PSMA), similar to several FDA-approved imaging and therapeutic agents. However, preclinical data demonstrate that ART-101 exhibits higher tumor uptake and retention, as well as lower normal tissue and salivary gland uptake, relative to current FDA-approved PSMA-targeting agents. Archeus plans to evaluate ART-101 as a theranostic radiopharmaceutical agent with the potential to deliver alpha particle-emitting isotopes with greater efficacy and safety compared with current standards of care.
Read the full story: https://www.biospace.com/press-releases/archeus-technologies-receives-fda-clearance-of-investigational-new-drug-application-for-art-101-in-development-for-the-treatment-of-prostate-cancer