The device is meant to not only target metastatic bone lesions, but also promote the growth of healthy bone.
The FDA as granted a breakthrough device designation to ZetaMet, a technology designed to target and resolve metastatic bone lesions, according to a press release by Zetagen Therapeutics.
ZetaMet, which was previously known as ZetaFuse, is a synthetic, small-molecule biologic technology that is meant to both target metastatic bone lesions while also inhibiting the growth of future lesions. The small molecule stimulates T cells an activate cells to grow health bone while preventing bone degradation. Preclinical studies have found that it has the ability to resolve existing bone lesions, inhibit pain, and stimulate targeted bone regeneration.
"We are pleased to receive this important designation from the Agency and look forward to partnering with them," said Joe C. Loy, CEO of Zetagen Therapeutics 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."
An inhuman clinical trial of ZetaMet is planned for early 2022.