Antelope Surgical Solutions, Inc. has announced FDA commercial IND approval for AS1986NS, a novel radiofluorescent drug designed to improve prostate cancer surgery. This approval paves the way for clinical trials to assess AS1986NS's ability to identify and delineate prostate cancer surgical margins, potentially improving surgical outcomes.
A New Class of Radiofluorescent Drugs
AS1986NS represents a new class of drugs developed by Antelope Surgical, termed 'radiofluorescent.' This innovative approach combines therapeutic radioisotopes (e.g., lutetium-175) and imaging radioisotopes (e.g., fluoride) with a fluorescent linker. This dual-purpose design allows for targeted cancer cell staining, enhancing surgical precision. Unlike existing fluorescent technologies that lack disease specificity, AS1986NS targets prostate-specific membrane antigen (PSMA) to illuminate the margins of prostate cancer cells directly.
Clinical Trial Plans
With the 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 evaluate the safety and efficacy of AS1986NS in human volunteers. Key investigators include Ashutosh Tewari, MD, MBBS, MCh, Kyung Hyun Kim, MD, and Po-Hung Lin, MD, PhD.
Integration with Artificial Intelligence
The clinical testing of AS1986NS will also advance the integration of computer vision with surgical robotics. When radiolabeled, AS1986NS generates medical images mapping cancer cells in both fluorescent and PET images. These images can be interpreted by advanced AI models, enhancing 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."
