FDA Grants Breakthrough Device Designation to ZetaMet for Metastatic Bone Cancers

The FDA’s Centers for Devices and Radiological Health has granted a breakthrough device designation to ZetaMet technology for use in the treatment of metastatic bone cancers and osteologic interventions.

The FDA’s Centers for Devices and Radiological Health has granted a breakthrough device designation to ZetaMet technology for use in the treatment of metastatic bone cancers and osteologic interventions, according to an announcement from Zetagen Therapeutics.1

The synthetic, small-molecule, inductive biologic technology was designed to target and resolve metastatic bone lesions, as well as inhibit future cancer growth and regenerating bone. The small molecule has had regulatory approval from the FDA since 1971, but scientists have since discovered a new pathway for it. If successful in human clinical trials, the molecule may shift treatment for patients with metastatic bone lesions and other osteologic conditions, according to the company.2

The technology works through a novel mechanism of action. The small molecule is administered to an affected area through a proprietary drug-eluting carrier. Once given, it serves to stimulate osteoblasts and inhibits osteoclasts. Data from preclinical studies examining the combination technology have showcased its ability to resolve existing metastatic bone lesions, inhibit pain, and encourage targeted bone regeneration.

“We are pleased to receive this important designation from the Agency and look forward to partnering with them,” Joe C. Loy, chief executive officer of Zetagen Therapeutics, stated in a press release. “Our researchers have discovered an entirely new pathway for an established molecule which, if proven successful in human clinical trials, could create a new treatment paradigm for the hundreds of thousands of patients living with cancers that involve metastatic bone lesions.”

Due to the success demonstrated in preclinical studies, the technology is being prepared for examination in a first-in-human clinical trial anticipated to launch in early 2022.

References

  1. ZetaMet receives breakthrough device designation from US Food and Drug Administration (FDA) for treatment of metastatic bone cancers. News release. Zetagen Therapeutics; December 1, 2021. Accessed December 1, 2021. https://bwnews.pr/32VEJlr
  2. Sectors: Oncology. Zetagen Therapeutics website. Accessed December 1, 2021. https://bit.ly/3ocHp6b