On November 9, 2020 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 a series of recently issued patents for its Phase 2b/3 clinical-stage lead product candidate, Validive (clonidine HCl mucobuccal tablet) (Press release, Monopar Therapeutics, NOV 9, 2020, View Source [SID1234570328]). These patents, including U.S. Patent No. 10,675,271, provide claims covering "Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy".

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"These recently issued patents broaden the patent protection for the use of Validive in cancer patients," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar. "Specifically, they provide protection into 2035 for the potential ability of Validive to prevent or treat common chemotherapy-associated side effects such as gastrointestinal disorders, respiratory disorders, fatigue and headache."

"According to the U.S. Centers for Disease Control and Prevention, about 650,000 cancer patients receive chemotherapy each year in the U.S., and most of these experience side-effects as a result of their treatment," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "These patents expand the potential use of Validive beyond the earlier allowed claims for the prevention of oral mucositis in patients receiving chemoradiotherapy. This in turn serves to advance Monopar’s mission to develop treatments that improve quality of life in cancer patients undergoing treatment."

Monopar is currently developing Validive for the prevention of chemoradiation-induced severe oral mucositis in oropharyngeal cancer patients (OPC), an indication which currently has no FDA approved treatment. Monopar’s Phase 2b/3 clinical trial in OPC patients is on track to start before year-end. The recently issued patents would provide protection should Monopar determine in the future to conduct additional Validive development activities related to adverse side effects of chemotherapy beyond OPC.