SYRACUSE, N.Y.--(BUSINESS WIRE)--Central New York Biotech Accelerator (CNYBAC) — Zetagen Therapeutics, Inc., a private, clinical stage, biopharmaceutical company focused on developing breakthrough therapies, via local administration, for metastatic breast cancer to bone and soft tissues, announced today that the first two patients have enrolled in the phase 2a study, which will evaluate ZetaMet™ (Zeta-BC-003) in the treatment of spinal metastatic lytic breast cancer lesions (ClinicalTrials.gov #NCT05280067).
“Our discovery is the first of its kind with the potential to be a curative therapy for this high unmet need,” stated Joe C. Loy, CEO of Zetagen. “Our vision is to deliver breakthrough therapies to all individuals affected by metastatic breast cancer, offering them pain relief, a higher quality of life, while increasing survival rates. The commencement of this study represents a major milestone in the development of ZetaMet™(Zeta-BC-003) and brings us closer to turning our vision into reality.”
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 prescription opioid use.
About ZetaMet™ (Zeta-BC-003)
ZetaMet™ (Zeta-BC-003) is a synthetic, small-molecule, delivered via a proprietary controlled-release carrier intended to resolve metastatic breast cancer bone lesions, inhibit pain while regenerating bone, with the potential to increase survival rates.
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.
The US Food & Drug Administration (FDA) has recognized Zetagen’s discoveries with multiple Breakthrough Designations including ZetaMet™ (Zeta-BC-003).
Zetagen with FDA approval via the Expanded Access (Compassionate Use) program 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 attrition of 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: https://www.tandfonline.com/doi/full/10.2217/pmt-2023-0069
About Zetagen Therapeutics
Founded in 2015, Zetagen Therapeutics is a private, clinical-stage, biopharmaceutical company dedicated to developing breakthrough therapies via local administration for metastatic breast cancer to bone and soft tissues which may provide increased survival rates.
The company's ‘Zeta” platform encompasses the following oncological drug candidates ZetaMet™ (Zeta-BC-003), ZetaMet-P™ (Zeta-PC-004) and ZetaMAST™ (Zeta-MBC-005). To learn more, visit www.zetagen.com
Zetagen will attend the upcoming San Antonio Breast Cancer Symposium (SABCS) and the JP Morgan Healthcare Conference.
Forward-Looking Statements
This press release contains certain forward-looking statements with the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.
i Pain Management. Volume 13, Issue 10, October 2023, Pages 569-577 https://doi.org/10.2217/pmt-2023-0069
