Antelope Surgical Solutions, Inc., a leader in radioligand fluorescent technology, is proud to announce that it has received commercial IND approval from the U.S. Food and Drug Administration (FDA) for its novel prostate cancer technology, AS1986NS. AS1986NS, a fluorescent and lutetium-175 bearing drug, represents a new class of drugs. This milestone paves the way for the initiation of clinical trials aimed at addressing prostate cancer identification and surgical margin delineation.
Antelope Surgical’s latest achievement represents a major leap forward in image-guided surgery and radiopharmaceuticals. The company introduces the term ‘radiofluorescent’ to describe a new class of drug that it manufactures in-house. This innovation enables the transformation of both small- and large-molecule ligand-targeted drugs into dual-purpose agents, combining therapeutic (e.g., actinium, lutetium, or other lanthanide) and imaging radioisotopes (such as fluoride) with a fluorescent linker. While fluorescence is currently used in surgery to assist with identifying vascular flow and staining tissues, existing fluorescent technologies lack specificity for disease. AS1986NS advances this field by enabling molecular targeting to directly stain specific cancer cells. This drug’s prostate-specific membrane antigen (PSMA)-targeted fluorescent capability, is designed to illuminate the margins of prostate cancer, enhancing surgical precision.
Commencing Clinical Trials
With commercial IND approval secured, Antelope Surgical is set to initiate Phase I/II clinical trials to assess the safety and efficacy of AS1986NS in human volunteers. The trials are scheduled to begin in the first quarter of 2025, pending IRB approval and NCT database registration. The multi-center trials will be led by the authority in surgical robotics 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 in New York, NY, and by Po-Hung Lin, MD, PhD of the Division of Urology, Department of Surgery at Chang Gung Memorial Hospital, Linkou Branch, Taoyuan, Taiwan.
Artificial Intelligence
The testing of AS1986NS will signify an important advancement in the integration of computer vision with surgical robotics. When Antelope Surgical’s technology is radiolabeled, it will generate medical images mapping specific cancer cells in both fluorescent and PET (positron emission tomography) images. This development is particularly significant for computer vision—advanced AI models capable of interpreting infrared and DICOM-medical image formats. AI in medical robotics and imaging will improve the accuracy and precision of image-guided surgery, facilitating more effective and targeted treatments.
Quote from Company Representative
“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.”
About Antelope Surgical Solutions, Inc
Antelope Surgical Solutions is an early–stage radiofluorescence pharmaceutical dedicated to advancing medicine and surgery through innovative research, in-house scalable chemical manufacturing, AI surgical tools, and time- and cost-saving targeted treatments. For more information, please visit www.antelopesurgical.com. Please email info@antelopesurgical.com if you are interested in donating to or investing in Antelope Surgical Solutions.
