Antelope Surgical Solutions has achieved commercial Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for AS1986NS, a novel prostate cancer technology. AS1986NS, a fluorescent and lutetium-175 bearing drug, represents a new class of drugs termed 'radiofluorescent' by the company. This approval paves the way for clinical trials aimed at improving prostate cancer identification and surgical margin delineation.
Radiofluorescent Technology
Antelope Surgical's innovation transforms ligand-targeted drugs into dual-purpose agents by combining therapeutic radioisotopes (e.g., lutetium) and imaging radioisotopes with a fluorescent linker. While fluorescence is used in surgery for vascular flow and tissue staining, AS1986NS advances this field by enabling molecular targeting to directly stain specific cancer cells through prostate-specific membrane antigen (PSMA) targeting.
Clinical Trial Plans
With IND approval secured, Antelope Surgical plans to initiate Phase I/II clinical trials in the first quarter of 2025, pending IRB approval and NCT database registration. These multi-center trials will assess the safety and efficacy of AS1986NS. According to Antelope Surgical Solutions, Ashutosh Tewari, MD, MBBS, MCh, Kyung Hyun Kim, MD, and Po-Hung Lin, MD, PhD, will lead the trials.
AI Integration
The testing of AS1986NS will advance the integration of computer vision with surgical robotics. When radiolabeled, the technology will generate medical images mapping specific cancer cells in both fluorescent and PET images. This development is significant for computer vision, enabling AI models to interpret infrared and DICOM-medical image formats, improving the accuracy and precision of image-guided surgery.
Company Perspective
"We are thrilled to have reached this important milestone," said Amy Wu, MD, CEO of Antelope Surgical. "This approval brings us one step closer to offering a new hope for patients suffering from all stages of prostate cancer. Our goal is to automate surgery in the future to impact outcomes and improve efficiency."
