Zetagen Therapeutics, Inc. has announced the enrollment of the first patients in its Phase 2a clinical study evaluating ZetaMet™ (Zeta-BC-003) for the treatment of spinal metastatic lytic breast cancer lesions. This study, registered as ClinicalTrials.gov #NCT05280067, marks a significant step forward in the development of a potential curative therapy for this high unmet need.
The Phase 2a study, conducted at the University of British Columbia in Vancouver, Canada, will span 26 weeks. It aims to evaluate the safety and efficacy of ZetaMet™ in treating vertebral bone defects caused by lytic metastatic breast cancer. The primary endpoints include the reduction of skeletal-related events (SREs), pain reduction, changes in vertebral body defect size, and postoperative prescription opioid use.
ZetaMet™: A Novel Approach to Metastatic Bone Lesions
ZetaMet™ (Zeta-BC-003) is a synthetic, small-molecule drug delivered via a proprietary controlled-release carrier. Its unique mechanism of action targets a novel molecular pathway to resolve metastatic breast cancer bone lesions, inhibit pain, and regenerate bone, potentially increasing survival rates. The FDA has granted Zetagen multiple Breakthrough Designations for its discoveries, including ZetaMet™.
Joe C. Loy, CEO of Zetagen, stated, "Our discovery is the first of its kind with the potential to be a curative therapy for this high unmet need. 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."
Clinical Data and Expanded Access Program
Zetagen has previously treated patients with ZetaMet™ under the FDA's Expanded Access (Compassionate Use) program, with results published in peer-reviewed journals. Two-year follow-up clinical data published in 2023 demonstrated the resolution of seven lytic lesions (both radiated and non-radiated), pain reduction, a four-fold decrease in opioid pain medication use, prevention of vertebral fractures, and an increased survival rate in a patient with Stage 4 breast cancer.
Study Design and Patient Population
The Phase 2a trial is enrolling Stage 4 breast cancer patients with spinal metastatic lytic lesions. The study will provide critical data on the safety and efficacy of ZetaMet™ in this patient population, addressing a significant unmet need in the treatment of metastatic breast cancer to bone.
