Hydronovo receives NIDCR UG3/UH3 Funding to Advance CVGN8 Toward Phase I Trial
Hydronovo, led by researchers at the University of California, San Francisco (Sarah Knox, PhD; Chelsea Bahney, PhD; and Sue Yom, MD, PhD.), has received UG3/UH3 support from the National Institute of Dental and Craniofacial Research for the XERO Study, a planned Phase I trial of Ceviginate (CVGN8) for radiation-induced xerostomia. The cooperative agreement provides $525,127 in initial funding. Hydronovo will serve as the study’s drug sponsor and a consortium partner on the award.
CVGN8 is an injectable regenerative hydrogel designed to restore salivary gland function by reactivating resident stem cells. The project’s initial phase will support the regulatory and operational work required to obtain Investigational New Drug clearance and begin clinical testing. A subsequent phase will evaluate the treatment’s safety, tolerability and preliminary efficacy in adults experiencing chronic dry mouth following radiation therapy for head and neck cancer.
The NIDCR UG3/UH3 mechanism provides the ideal framework to advance CVGN8 into clinical testing and leverages prior translational support from C- DOCTOR (NIDCR U24DE026914 and U24DE029463). The award marks an important step toward translating CVGN8 from preclinical research into a potential regenerative treatment to improve the quality of life for head and neck cancer patients suffering from radiation-induced xerostomia.