Pathways Bioscience Announces National Institutes of Health NIDCR SBIR Phase I Award to Develop Potential Oral Mucositis Treatment by Nrf2 Activation

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Pathways Bioscience’s technology to upregulate cell protection mechanisms and decrease inflammation to be used to develop therapeutics for oral mucositis supported by SBIR grant from the National Institute of Dental and Craniofacial Research.

Pathways Bioscience, LLC announced today that the National Institute of Dental and Craniofacial Research (NIDCR) has awarded the Company a Small Business Innovation Research (SBIR) Phase I grant to pursue research and development of its PB201 topical formulation for use against oral mucositis, a common cancer therapy side effect that impacts hundreds of thousands of patients in the US each year. PB201 activates the Nuclear Factor, Erythroid 2 Like 2 (NFE2L2, also known as Nrf2) transcription factor pathway, which regulates the expression of a large group of cell protective and anti-inflammatory genes.

“We have discovered that PB201 potently activates the Nrf2 pathway and increases the expression of a wide variety of cytoprotective genes, making it a promising agent for use in the prevention or treatment of a variety of health conditions including oral mucositis,” said Dr. Joe M. McCord, Clinical Professor of Medicine at the University of Colorado School of Medicine and cofounder of Pathways Bioscience, LLC.

In the project entitled “A Topical Nrf2 Activator for Oral Mucositis,” NIH Award number R43DE026086, scientists at Pathways Bioscience will collaborate with Dr. Stephen Sonis and his team at Biomodels. “Oral mucositis remains a devastating and critically dose-limiting side effect of the most common forms of cancer therapies for which there are no effective interventions. In the upcoming preclinical study at Pathways Bioscience and Biomodels, we will evaluate the potential of the topical Nrf2 activator PB201 to mitigate the pathophysiology of oral mucositis,” said Stephen T. Sonis, DMD, DMSc, Senior Surgeon at Brigham and Women’s Hospital and the Dana-Farber Cancer Institute and Chief Scientific Officer at Biomodels, LLC.

“Dysregulation of inflammation and increased oxidative stress play important roles in the pathophysiology of oral mucositis,“ said Brooks M. Hybertson, PhD, President and CEO of Pathways Bioscience and Principal Investigator on the project. “Our preliminary data with our PB201 formulation have been very encouraging, demonstrating strong Nrf2 activation and increased transcription of genes that are involved in protection against inflammation and oxidative stress. We are honored and grateful to receive this SBIR award from NIDCR to pursue the development of much-needed therapeutics that help patients avoid the devastating problem of oral mucositis.”

The research reported above is supported by the National Institute of Dental and Craniofacial Research of the National Institutes of Health under Award Number R43DE026086. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Pathways Bioscience

Pathways Bioscience LLC is a biomedical sciences company focused on discovering and developing new agents, both small molecule drugs and dietary supplements, that influence gene expression pathways and exert beneficial effects, with particular emphasis on the Nuclear Factor, Erythroid 2 Like 2 (NFE2L2, or Nrf2) gene transcription factor, known as the master regulator of cell protection mechanisms. These activities are based on the concept that the best way to improve healthspan and overcome the health and wellness problems associated with aging is to support the body’s own defense mechanisms that allow it to protect and heal itself. The company's headquarters are in Aurora, Colorado. For further information regarding Pathways Bioscience, LLC, please visit the Company’s Website at


The National Institute of Dental and Craniofacial Research (NIDCR) is the US federal government's lead agency for scientific research on dental, oral and craniofacial health and disease. NIDCR is one of the National Institutes of Health (NIH) in the U.S. Department of Health and Human Services. For more information about NIDCR and its programs, visit

About NIH

NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit

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Brooks Hybertson
Pathways Bioscience, LLC
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