Antelope Surgical Solutions Achieves Commercial Investigational New Drug (IND) Approval for PSMA-Fluorescent Novel Drug AS1986NS

NEW YORK, Nov. 12, 2024 /PRNewswire/ -- 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.

Breakthrough in Prostate Cancer

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  [email protected] if you are interested in donating to or investing in Antelope Surgical Solutions.

Forward-Looking Statements

This news 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, 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: those associated with the success of research and development programs, the ability to raise 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.