Zetagen Announces Publication in Pain Management of Early Data Using ZetaMet™ as a Potential Treatment for Bone Metastases

2023-10-10

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Peer-reviewed case report examines use of investigational treatment in a Stage 4 metastatic breast cancer patient. Case study demonstrated resolution of lytic lesions, significant reduction in pain and prevention of fracture. ZetaMet™ is a first-of-its kind molecular pathway designed to suspend cancer, inhibit pain, and regenerate bone. ZetaMet™ was granted FDA Breakthrough Device Designation in 2021 and is in Phase 2a clinical trials for treatment of metastatic breast cancer lesions to bone as part of advanced stage cancer therapy. SYRACUSE, N.Y.--(BUSINESS WIRE)-- Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company focused on driving breakthrough innovation in the treatment of metastatic cancers to bone and soft tissue organs as well as osteologic interventions, today announced publication of early, human clinical data in the peer-reviewed journal Pain Management on ZetaMet™ for the treatment bone metastases. This case study, entitled Treating Bone Metastases with Local Therapy in a Breast Cancer Patient Resulted in Decrease Pain and Prevented Fracture, demonstrated resolution of lytic lesions, significant reduction in pain and prevention of fracture in a patient living with Stage 4 breast cancer being treated with ZetaMet™. To view the publication via open access, go to: ZetaMet™ is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone. The small molecule has been approved by the U.S. Food and Drug Administration (FDA) since 1971. Zetagen scientists have discovered an entirely new pathway for this established molecule which, if proven successful in human clinical trials, could create a new treatment paradigm for patients living with metastatic bone lesions and other osteologic conditions. “Recently, I had the opportunity to spend some time with this patient. I will always remember what she said to me: ‘thank you for giving me more time’,” said Joe C. Loy, Chief Executive Officer of Zetagen Therapeutics. “We are grateful to have had the opportunity to provide ZetaMet™ to this patient and we remain cautiously hopeful as we await results from our on-going Phase 2 clinical trial.” “We recognize that these results are from a single patient and are prudently hopeful for similar outcomes from our ongoing ZetaMet™ clinical trial,” said Bryan Margulies, PhD, Chief Scientific Officer of Zetagen Therapeutics. “I am encouraged that at the two-year time period this patient does not have active tumor at the treatment sites, and that the sacral lesion which was not treated with fractionated radiation completely resolved." Lytic lesions can cause severe, debilitating pain in patients with advanced cancer. Patients with these lesions often experience a reduced quality of life with multiple skeletal-related events (SREs), including fractures, spinal cord compression, elevated levels of calcium in the blood or “hypercalcemia”, bone marrow infiltration and severe bone pain.1 Bone metastases are also a major cause for morbidity in patients with advanced stage cancer.2 “We are inspired with these initial results and thankful this patient was able to experience such pain relief and avoid a skeletal related event (SRE),” said Nikhil Thakur, MD, Chief Medical Officer of Zetagen Therapeutics. “The ease of administering of the ZetaMet™ product, via a percutaneous outpatient procedure could benefit these very ill patients and accelerate physician adoption,” said David Palma, MD, interventional radiologist administering the therapy in this case study. Zetagen is focused on the more than 620,000 people in the United States, and more globally, living with metastatic cancers. This number is expected to reach more than 690,000 by the year 2025.3 Bone metastases are common among cancer patients and occur when cells from the primary cancerous tumor relocate to the bone. When these cancers relocate, they can cause changes to the bone, damaging it in a process called osteolysis. Osteolysis can cause small holes within the bone, weakening it and increasing the risk of breakage. These holes are called “lytic lesions.” Among cancers which metastasize to bone, Breast and Prostate are most prevalent, amounting to approximately 70-percent of cases.4 The Company has been issued two Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA) for ZetaMet™ and ZetaFuse® and issued multiple patents from the U.S. Patent and Trademark Office (USPTO). Zetagen is funded through Series A and B rounds of funding, Phase I and II National Institute of Health (NIH) / National Cancer Institute (NCI)Cancer Institute (NCI) grants and angel investors. About Zetagen Therapeutics Founded in 2015, Zetagen Therapeutics is a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic cancers to bone and other organs as well as osteologic interventions. Zetagen exclusively-licensed the platform technology from the State University of New York in 2016. The Company was recently issued IP directly associated with the development of ZetaMAST™. ZetaMAST™ is a first-of-its kind formulation specifically designed for intra-tumoral injection in soft tissue organs like the liver, lung and or brain. The company's pipeline encompasses further oncological solutions, targeting metastatic prostate cancer and addressing Skeletal Related Events (SREs), such as Z-Pros™ and ZetaMet Flowable™, alongside supplementary treatments for osteological conditions like ZetaFuse™ and ZetaBase®. To learn more, visit . 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 statement 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. Source: Zetagen Therapeutics, Inc. 1 Ibrahim T, Mercatali L, Amadori D. A new emergency in oncology: Bone metastases in breast cancer patients (Review). Oncol Lett. 2013;6(2):306-310. doi:10.3892/ol.2013.1372 2 Cecchini M, Wetterwald A, Pluijm G, Thalmann G. Molecular and biological mechanisms of bone metastasis. EAU Update Series 2005;3:214-26. [Google Scholar] 3 Gallicchio L, Devasia TP, Tonorezos E, Mollica MA, Mariotto A. Estimation of the Number of Individuals Living With Metastatic Cancer in the United States, JNCI: Journal of the National Cancer Institute Cancer Institute, 2022;, djac158, 4 Li S, Peng Y, Weinhandl ED, et al. Estimated number of prevalent cases of metastatic bone disease in the US adult population. Clin Epidemiol. 2012;4:87-93. doi:10.2147/CLEP.S28339