Antelope Surgical Solutions has announced that it has received FDA approval for its novel prostate cancer technology, AS1986NS. This drug, which bears both fluorescent and lutetium-175 components, is poised to begin Phase I/II clinical trials in early 2025, pending IRB approval and NCT database registration. AS1986NS represents a new class of drugs referred to as 'radiofluorescent,' combining therapeutic and imaging capabilities to enhance the precision of prostate cancer surgery.
Radiofluorescent Technology
AS1986NS is designed to target prostate-specific membrane antigen (PSMA), illuminating the margins of prostate cancer cells to improve surgical accuracy. This innovation transforms ligand-targeted drugs into dual-purpose agents by combining therapeutic radioisotopes (such as actinium or lutetium) with a fluorescent linker. Unlike existing fluorescent technologies that lack disease specificity, AS1986NS enables molecular targeting, directly staining specific cancer cells.
Clinical Trial Plans
The upcoming Phase I/II clinical trials will evaluate the safety and efficacy of AS1986NS in human volunteers. These multi-center trials will be led by surgical robotics experts including Ashutosh Tewari, MD, MBBS, MCh, Kyung Hyun Kim, MD, Professor and Chair of the Milton and Carroll Petrie Department of Urology at the Icahn School of Medicine at Mount Sinai, and Po-Hung Lin, MD, PhD of the Division of Urology, Department of Surgery at Chang Gung Memorial Hospital.
Integration of AI and Computer Vision
AS1986NS is designed to integrate computer vision with surgical robotics. When radiolabeled, the technology will generate medical images mapping specific cancer cells in both fluorescent and PET images. This advancement is expected to improve the accuracy and precision of image-guided surgery through the use of advanced AI models capable of interpreting infrared and DICOM-medical image formats, facilitating more effective and targeted treatments.
Company Vision
"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."
