Benzinga | Aug 5, 2021 08:29AM EDT

Monopar Therapeutics Reports Reached Target Number Of Clinical Sites In Phase 2b Portion Of 2b/3 Validive VOICE Trial

Monopar Therapeutics Inc. (NASDAQ:MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced it has successfully reached its target of 20 activated clinical trial sites in the Phase 2b portion of the VOICE trial.

Validive(r) is a small, easy-to-use mucobuccal tablet that can be self-administered in the patient's home setting. The VOICE study evaluates Validive(r) for the prevention of severe oral mucositis (SOM) in oropharyngeal cancer patients. SOM results from the chemoradiation used to treat oropharyngeal cancer (OPC). There is no FDA-approved preventative or treatment option for the estimated >40,000 OPC patients in the US annually who are at-risk of developing SOM.

"We are very pleased to reach this clinical milestone and to achieve clinical site enrollment rates that have exceeded our base case projections to date," said Octavio Costa, MD, Monopar's Chief Medical Officer. "We are proud of our clinical team's efforts and grateful for the support from participating patients and staff at our clinical sites, who are joining us in our focus to prevent this painful, debilitating condition that results in patients losing the ability to drink and/or eat."

"In planning for success and the Phase 3 portion of the VOICE trial, and as a result of strong interest from sites in joining the trial, we are going to expand the number of sites beyond the original 20 targeted," said Chandler Robinson, MD, Monopar's Chief Executive Officer. "Because of interest outside the US, we are also looking at activating sites in additional countries, potentially later this year."

Monopar anticipates reaching the interim analysis of the Phase 2b/3 Validive(r) VOICE trial in the first half of 2022. Further information about the trial is available at www.ClinicalTrials.gov under study identifier NCT 04648020.