On September 13, 2021 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, reported it has received authorization to proceed with the Phase 2b/3 VOICE clinical trial in France (Press release, Monopar Therapeutics, SEP 13, 2021, View Source [SID1234587624]). 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) (Free ESMO Whitepaper) Congress 2021. Monopar anticipates reaching the interim of the Phase 2b/3 VOICE trial in the first half of 2022.
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"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 provides for prolonged and enhanced local delivery of clonidine to the regions of oral mucosal radiation damage in OPC patients. The tablet is self-administered once daily in the patient’s home setting with the patient placing it under the upper lip where it adheres to the gums and dissolves over several hours, continuously releasing clonidine into the saliva. Clonidine agonizes the alpha-2 adrenergic receptor on macrophages (white blood cells present in the immune tissues of the oropharynx), decreasing the macrophages’ expression of the destructive cytokines that are released in response to radiotherapy. A completed double-blind, randomized, placebo-controlled Phase 2 clinical trial of Validive showed reduced incidence compared to placebo (absolute decrease of 26%, relative decrease of 40%) in OPC patients treated with Validive 100 µg, a safety profile similar to placebo, and a high rate of treatment compliance (over 90%). Monopar expects to continue activating sites in the US and abroad for this adaptive Phase 2b/3 VOICE clinical trial. Further information about the trial in the US is available at www.ClinicalTrials.gov under study identifier NCT 04648020.