RxBio was formed around novel and proprietary small-molecule technology developed at the University of Tennessee Health Science Center (UTHSC) in Memphis and licensed from the University of Tennessee Research Foundation (UTRF).
RxBio's technology platform is broadly based and includes:
- Lead Compound-Rx100
- Rx100 is poised for human clinical safety trials in the near future.
- Recent murine and nonhuman primate studies (required under FDA’s “Animal Rule” for demonstration of safety and efficacy) have confirmed Rx100’s ability to dramatically improve survival after high doses of irradiation
- Treatment of secretory diarrhea
- Prevention of NSAID-induced stomach erosions (e.g., aspirin)
- Other Technology
- Compounds for treatment and prevention of hematological-ARS
- Anti-inflammatory compounds
- Compound for treatment of glioma – a universally fatal form of brain cancer
In 2011, the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services provided approximately $15 in funding for RxBio to proceed with the development of Rx100 for use in mitigation (post-exposure prophylaxis) of GI-ARS following exposure to potentially lethal ionizing radiation. Accordingly, RxBio completed upgrade to commercial scale production of Rx100. RxBio has initiated and is near completion of animal toxicology studies in advance of clinical studies scheduled for Q1 2015. This seed money also provided funds for RxBio to complete development of Animal Models of GI-ARS and to upgrade our animal facilities to Good Laboratory Practice (GLP) status. This funding has put RxBio in position to file for an Emergency Use Authorization with FDA in the near future.
In 2013 the National Institute of Allergy and Infectious Diseases (NIAID) committed to an additional $6M in funding for 3 years to continue testing Rx100 in Animal Models of gastrointestinal (GI) acute radiation syndrome (ARS). These Animal Models were recommended by the US Food and Drug Administration (FDA) for registration trials for any new drug intended for this use.