Research and Development
Biothera is working with leading academic and government researchers on applications for the technology.
- The National Institute of Health
- Brown Cancer Center, University of Louisville
- The Mayo Clinic
- Warren Alpert Medical School, Brown University
- Ohio State University
- US Armed Forces Radiobiology Research Institute
- Defence R&D Canada -- Suffield, Canadian Dept. of National Defence
Preclinical studies related to the pharmacological effects of Imprime PGG in cancer, and infectious disease and hematopoiesis indications have been published in numerous peer reviewed scientific journals (Blood, Journal of Immunology, Cancer Research).
Significant mechanism research has been done in multiple cancer studies in combination with anti-cancer monoclonal antibodies and have verified anti-tumor activity and assisted in identifying the unique mechanism of action of Imprime PGG. In addition to the mechanism data, the results of these studies demonstrated significant improvement in survival for animals treated with Imprime PGG in combination the anti-tumor monoclonal antibody as compared with the monoclonal antibody only. Xenograft studies with mice implanted with various human tumor cell lines and treated with Imprime PGG in combination with three different approved human monoclonal antibody drugs have also demonstrated enhanced efficacy and confirmed the mechanism of action of Imprime PGG.
Biothera has research demonstrating its compounds can dramatically enhance immune response to pathogenic challenges including antibiotic-resistant bacteria when used in combination with antibiotics. Biothera also has research studying the compounds ability to regenerate blood cells following chemotherapy or radiation. Research for this hematopoietic indication is primarily being funded through a Small Business Innovative Research (SBIR) grant from the National Institute of Health.
Biothera has performed a full series of toxicology studies have been conducted with Imprime PGG, which includes single-dose, multiple-dose studies in rodents and non-human primates, including reproductive, mutagenicity, and immunogenicity/antigenicity studies. No significant adverse findings were observed that would cause concern in the continued development of Imprime PGG.