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Antelope Surgical Solutions Receives Commercial Investigational New Drug (IND) Designation for Novel PSMA Fluorescent Drug AS1986NS

NEW YORK, November 12, 2024 /PRNewswire/ — Antelope Surgical Solutions, Inc.a leader in radioligand fluorescence 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 drug containing lutetium-175, represents a new class of drugs. This milestone paves the way for the start of clinical trials to detect prostate cancer and delineate the surgical margin.

Breakthrough in prostate cancer

Antelope Surgical The latest achievement represents a major advance in image-guided surgery and radiopharmaceuticals. The company introduces the term 'radiofluorescent' to describe a new class of drugs manufactured internally. This innovation enables the conversion of both small and large molecular ligand-targeted drugs into dual-use agents by combining therapeutic (e.g. actinium, lutetium or other lanthanides) and imaging radioisotopes (e.g. fluoride) with a fluorescent linker become. While fluorescence is currently used in surgery to identify vascular flow and stain tissue, existing fluorescence 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)-targeting fluorescence ability is intended to illuminate the edges of prostate cancer, improving surgical precision.

Start of clinical studies

Once commercial IND approval is secured, Antelope Surgical will initiate Phase I/II clinical trials to evaluate the safety and efficacy of AS1986NS in human volunteers. Trials are scheduled to begin in the first quarter of 2025, subject to IRB approval and registration in the NCT database. The multicenter studies are led by the authority on surgical robotics Ashutosh TewariMD, MBBS, MCh, Kyung Hyun KimMD, Milton and Carroll Petrie Professor and Chair of the Department of Urology at the Icahn School of Medicine Mount Sinai In New York, NYand by Po-Hung Lin, MD, PhD of the Department of Urology, Department of Surgery, Chang Gung Memorial Hospital, Linkou Branch, Taoyuan, Taiwan.

Artificial intelligence

The test of AS1986NS will represent an important advance in the integration of computer vision with surgical robotics. When Antelope Surgical's technology is radiolabeled, medical images are created that depict specific cancer cells in both fluorescent and positron emission tomography (PET) images. This development is particularly important 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, enabling more effective and targeted treatments.

Quote from a company representative

“We are very pleased to have reached this important milestone,” he said Amy WuM.DCEO of Antelope Surgical. “This approval brings us one step closer to offering new hope to patients suffering from all stages of prostate cancer. Our goal is to automate surgical procedures in the future to improve outcomes and improve efficiency.”

About Antelope Surgical Solutions, Inc

Antelope Surgical Solutions is an early-stage radiofluorescence drug product dedicated to advancing medicine and surgery through innovative research, in-house scalable chemical manufacturing, surgical AI tools, and time- and cost-saving targeted treatments. For more information, see www.antelopesurgical.com. Please send an email [email protected] If you are interested in donating to or investing in Antelope Surgical Solutions.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “potential,” “believes” and “if” are intended to identify forward-looking statements. forward-looking statements, although not all forward-looking statements contain such terms. You are cautioned that such statements are subject to risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those projected in the forward-looking statements. These risks include, but are not limited to: risks related to the success of research and development programs, the ability to obtain additional funding and the need to obtain regulatory approval. Forward-looking statements are made as of the date hereof and Antelope Surgical has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE Antelope Surgical Solutions, Inc.

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