China-based biopharmaceutical company RiboX Therapeutics Ltd. announced on Sunday that it has dosed the first patient in its first-in-human (FIH) Phase I/IIa clinical trial (SPRINX-1) evaluating the safety and efficacy of RXRG001.
RXRG001 is claimed to be the first-ever circular RNA therapy to receive FDA IND approval and is intended for the treatment of radiation-induced xerostomia and hyposalivation.
Principal Investigator, Henry T Hoffman, MD, MS, FACS, professor, Otolaryngology and editor, Iowa Head and Neck Protocols of University of Iowa, said, 'Patients suffering radiation-induced xerostomia face a need for new therapeutic options. RXRG001 introduces an innovative approach offering hope for my patients. We are proud to be the first site to treat a patient with RXRG001 and look forward to continuing to collaborate with RiboX and other investigative centres to rapidly enrol patients in this FIH trial. I am glad that our first patient is tolerating the investigational product well.'
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval