On February 16, 2021 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, reported it has dosed the first patient in its Phase 2b/3 VOICE trial of Validive for the prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer (VOICE) (Press release, Monopar Therapeutics, FEB 16, 2021, View Source [SID1234575094]).

Validive’s mucoadhesive buccal tablet formulation allows for prolonged and enhanced local delivery of drug to the regions of mucosal radiation damage, and its easy application under the upper lip allows for convenient once-daily self-administration in the patient’s home setting.

"With this important milestone accomplished we are excited to be one step closer to bringing Validive to the approximately 40,000 OPC patients per year in the US that have no effective options for preventing or treating their chemoradiotherapy-induced SOM," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "SOM is a painful and debilitating severe adverse effect of chemoradiotherapy (CRT) treatment and can have significant negative impacts on clinical outcomes as well as quality of life in both the short and long term."

"The number of newly diagnosed individuals with oropharyngeal cancer is growing," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar. "CRT is the standard of care for OPC, but unfortunately 60-70% of OPC patients undergoing CRT will develop severe oral mucositis in the course of their treatment."

The completed Validive Phase 2 trial showed that administering a single, once daily 100µg Validive tablet resulted in a 40% reduction in the incidence of SOM compared to placebo in OPC patients undergoing CRT treatment. Up to approximately 260 patients will be enrolled in the current multi-center, randomized, double-blind, placebo-controlled, adaptive design Phase 2b/3 VOICE trial.

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 they release 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%).

About Severe Oral Mucositis
Severe oral mucositis (SOM) is a painful and debilitating inflammation and ulceration of the mucous membranes lining the oral cavity and oropharynx in response to insults such as chemoradiation treatment (CRT). SOM is the most frequent major side effect experienced by oropharyngeal cancer patients, experienced by a majority of those undergoing CRT. SOM impacts both quality of life and clinical outcomes for these patients. SOM prevents patients from drinking and/or eating, and can lead to severe weight loss, opiate usage, and the use of feeding tubes as well as intravenous supplementation to keep alive. Patients who develop SOM can become hospitalized, and symptoms can force patients to prematurely stop cancer treatment, reducing treatment efficacy and long-term survival.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!