Monopar Announces Completion of Phase 2b Enrollment & Commencement of Phase 3 Enrollment in its VOICE Trial for Severe Oral Mucositis
Monopar Therapeutics Inc. recently announced an update on its actively enrolling Validive Phase 2b/3 VOICE clinical trial for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer. This is an indication for which there is currently no FDA-approved preventative or treatment.
Monopar announced it has enrolled greater than 130 patients, has completed enrollment for the Phase 2b portion of the trial, has activated a total of 68 sites, has recently expanded the trial to include sites in Germany and Poland, and has commenced enrollment for the Phase 3 portion of the trial. The blinded interim analysis of clinical data from the Phase 2b patient cohort of the trial, to be performed by an independent data monitoring board, will be used to guide the Company as to whether or not to continue enrolling the Phase 3 portion of the trial. This analysis should be complete with interim results announced during Q1 2023.
“In planning for success for a potential positive go/no-go outcome from the upcoming Q1 2023 interim analysis, we have been actively enrolling patients and adding clinical sites to the VOICE trial and expect to continue doing so,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer. “Expanding to include additional sites outside of the U.S. will dramatically increase the number of patients available for enrollment in the study.”
Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients. Monopar’s pipeline consists of Validive for the prevention of chemoradiotherapy-induced severe oral mucositis in oropharyngeal cancer patients; camsirubicin for the treatment of advanced soft tissue sarcoma; a late-stage preclinical antibody, MNPR-101, for advanced cancers and severe COVID-19; and an early-stage camsirubicin analog, MNPR-202, for various cancers. For more information, visit www.monopartx.com.
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