Press release
Monopar Expands Phase 2b/3 VOICE Clinical Trial to Europe
Trial launch in Europe coincides with the Company’s upcoming presentation at the European Society for Medical Oncology Congress WILMETTE, Ill., Sept. 13, 2021
About this update from Monopar Therapeutics Inc.
[{"type":"text","content":"Trial launch in Europe coincides with the Company’s upcoming presentation at the European Society for Medical Oncology Congress WILMETTE, Ill., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced it has received authorization to proceed with the Phase 2b/3 VOICE clinical trial in France. The trial, which began earlier this year in the US, is evaluating Validive® (clonidine HCl MBT) to prevent the onset of severe oral mucositis (SOM) in oropharyngeal cancer (OPC) patients treated with chemoradiotherapy. The trial’s rationale and design will be presented at the upcoming European Society for Medical Oncology (ESMO) Congress 2021. Monopar anticipates reaching the interim of the Phase 2b/3 VOICE trial in the first half of 2022. “Building on the numerous clinical sites we have activated in the US, we are pleased to receive authorization to proceed with the VOICE trial in France,” said Octavio Costa, MD, Chief Medical Officer of Monopar. “Expansion to Europe marks another important milestone in this late-stage trial, and we anticipate dosing patients in France in the not too distant future with additional European countries to follow.” “SOM is a painful, debilitating side effect of chemoradiotherapy that results in patients’ inability to drink and/or eat, and it has no approved preventative or treatment options,” said Andrew Mazar, PhD, Monopar’s Chief Scientific Officer. “We are pleased to share the rationale and design for our Phase 2b/3 VOICE clinical trial with the European oncology community as we continue in our efforts to prevent this life-altering condition.” ESMO Congress poster presentation details are as follows: e-Poster: 1729TiP. “Rationale and design of the Phase 2b/3 VOICE trial of clonidine MBT for the prevention of severe oral mucositis in patients with OPC receiving chemoradiotherapy.” Presenting Author: Dr. Andrew P. Mazar, Chief Scientific Officer of Monopar Therapeutics Session: 247-15 e-Poster Display Date: 16 Sept 2021 8:30 AM CEST, virtual meeting website channel 7 About Validive® Validive (clonidine mucobuccal tablet; clonidine MBT) is a novel mucobuccal tablet (MBT) formulation. The mucobuccal tablet provid...