On May 6, 2025 Zetagen Therapeutics, Inc., a private, clinical stage, biopharmaceutical company focused on developing breakthrough therapies, via local administration, for metastatic and primary breast cancers, reported they have successfully completed enrollment in their phase 2a study, which will evaluate ZetaMet (Zeta-BC-003) in the treatment of spinal metastatic lytic breast cancer lesions (ClinicalTrials.gov #NCT05280067) (Press release, Zetagen Therapeutics, MAY 6, 2025, View Source [SID1234652599]).

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"We are excited to reach another critical milestone in the development of ZetaMet (Zeta-BC-003), " said Joe C. Loy, Zetagen’s Chief Executive Officer. "We launched this study with stage IV breast cancer patients suffering from spinal metastases, because we recognize their severe pain and how debilitating it is, and that current treatments remain largely palliative. Our objective with ZetaMet is to eliminate cancer cells responsible for bone destruction, alleviate pain, stimulate the regeneration of bone lost to lytic lesions, enhance overall quality of life, while improving survival rates."

The 26-week study, conducted at the University of British Columbia, (UBC) Vancouver, BC, Canada, will evaluate the safety and efficacy of ZetaMet (Zeta-BC-003) in treating vertebral bone defects created by lytic metastatic breast cancer. The study will measure the reduction of skeletal related events (SRE), pain, change in vertebral body defect size, and postoperative prescribed opioid use. The Company anticipates reporting top-line results early fourth quarter of 2025.

Zetagen expects to submit an Investigation New Drug (IND) application to the U.S. Food and Drug Administration ("FDA"), leveraging its FDA’s Breakthrough designations.

About ZetaMet (Zeta-BC-003)
ZetaMet’s (Zeta-BC-003) small molecule mechanism of action (MOA) via a novel molecular pathway initiates a circuit which results in tumor cell death.

ZetaMet (Zeta-BC-003) is the first-of-its-kind, synthetic, small-molecule delivered via a proprietary controlled-release carrier intended to resolve metastatic breast cancer bone lesions, administered locoregionally, to inhibit pain while regenerating new bone, with the potential to increase survival rates.

The US Food & Drug Administration (FDA) has recognized Zetagen’s discoveries with multiple Breakthrough Designations including ZetaMet (Zeta-BC-003).

Zetagen with FDA and Health Canada (HC) approval via their Expanded Access (Compassionate Use) programs has treated several patients with ZetaMet (Zeta-BC-003) with results published in multiple peer-reviewed journals.

Peer-reviewed 2-year follow up clinical data published in 2023 on ZetaMet (Zeta-BC-003) demonstrated resolution of 7 lytic lesions (radiated and non-radiated), reduction in pain, significant reduction in opioid pain medication (4-fold), prevention of vertebral fracture, and increased survival rate in a patient living with Stage 4 breast cancer.[i] To view this publication via open access, go to: View Source