ZetaMet™ Receives Health Canada Authorization for Phase 2a Study in Treating Metastatic Bone Lesions

2022-01-18

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Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, today announced it has received authorization from Health Canada to conduct a Phase 2a study, examining the safety and efficacy of ZetaMet™ for the treatment of metastatic bone lesions. “The start of this study marks a critical point in the development of ZetaMet™,” said Bryan Margulies, PhD, chief scientific officer of Zetagen Therapeutics. “So far, our combination technology has, in preclinical studies, demonstrated its ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration. Now, our goal is to prove this outcome in human application.”

ZetaMet™ works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as “osteoblasts”, and inhibits cells associated with bone degradation called “osteoclasts”.

“We know that bone metastases are common among late-stage cancer patients and the pain associated with them is debilitating,” said Joe C. Loy, CEO of Zetagen Therapeutics. “We look forward to this important next step in the development of ZetaMet™ which, if successful, will bring this novel therapy one step closer to a reality for patients who need it most.”

Bone metastases 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.1

The Phase 2a study will be conducted at a single site in partnership with McGill University, Montreal, Quebec. The study will enroll 10, Stage 4 breast cancer patients, pre-radiation, who present with lytic lesions created by metastatic tumors in their spinal column. The year-long study is scheduled to be completed by Q1 2023.

About Zetagen Therapeutics Founded in 2015, Zetagen is a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions. Our multi-patented, ZetaMet™ technology is a first-of-its kind molecular pathway designed to suspend cancer, inhibit pain, and regenerate bone. Zetagen exclusively-licensed the platform technology from the State University of New York in 2016. This novel therapy, a drug-eluting implant technology, has successfully passed its preclinical trials and is being prepared for its first human clinical trial in early 2022. In addition to ZetaMet™, the Company’s pipeline includes other oncologic treatments for Skeletal Related Events (SREs), i.e., ZetaMet™ Flowable™ and ancillary osteologic treatments including, ZetaFuse™, ZetaSet™, ZetaDent™ and ZetaBase™.

1 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

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