BIO 300 – A Unique, Highly Selective Modulator of Inflammation, Cell Cycle Arrest and DNA Damage Repair
BIO 300 is being developed for multiple indications utilizing a variety of patented formulations. Indications for BIO 300 include:
- treatment of inflammatory pulmonary injury (e.g., related to respiratory viral infection, trauma, sepsis, inhalation of harmful substances)
- as a medical countermeasure to increase survival in patients acutely exposed to myelosuppressive doses of radiation
- as a medical countermeasure to mitigate the delayed effects of acute radiation exposure, particularly pneumonitis and fibrosis of the lungs
- the protection of normal tissues and as an adjunctive treatment for solid tumor cancers in patients undergoing radiation or chemoradiation therapy
The active ingredient in BIO 300 is a small molecule with limited solubility and poor oral bioavailability, which prevents absorption of therapeutic doses without proper formulations. Humanetics has developed a patented, stable nano-particle formulation that greatly improves oral bioactivity (see Pharmacokinetic Data).
BIO 300 has a variety of biological effects, which leads to its unique efficacy as a radiation modulator. These include effects on cell cycle regulation, oxidative stress, DNA damage repair, inflammation and fibrosis. (see Mechanism of Action).
BIO 300's unique mechanism allows it to selectively protect normal tissues and to avoid protection of tumor cells. BIO 300 is in a Phase I/II clinical trial in patients undergoing radiochemotherapy for non-small cell lung cancer. See more about this trial.
Given the similarity between radiation- and COVID-19-induced inflammation, and the demonstrated safety profile of BIO 300, it is an excellent drug candidate to treat COVID-19 patients. BIO 300 is currently in a Phase 2 clinical trial to evaluate its efficacy to mitigate impaired pulmonary function in COVID-19 patients recently discharged from the hospital.