BIO 300 – A Unique, Highly Selective Radiation Modulator
BIO 300 is being developed as a radiation modulator for multiple indications. The active ingredient of BIO 300 is synthetic nano-particle genistein [5,7-dihydroxy-3-(4-hydroxyphenyl)-chromen-4-one]. Genistein has been extensively studied as a potential cancer therapeutic since its discovery in 1987 as a potent tyrosine kinase inhibitor, as these protein kinases are often mutated in cancers. It was the subject of a 15 year program of study by the Armed Forces Radiobiology Research Institute where its radioprotective effects were confirmed. Genistein has very low solubility, which prevents absorption of therapeutic doses without proper formulations. Humanetics has developed a patented, stable nano-particle formulation that greatly improves the oral bioactivity of genistein (see Pharmacokinetic Data).
Genistein has a variety of biological effects, which leads to its unique efficacy as a radiation modulator. These include effects on cell signaling pathways involved in apoptosis, cell cycle regulation, oxidative stress, inflammation and metastasis. (see Mechanism of Action).
BIO 300's unique, selective mechanism sensitizes tumor cells to radiation-induced killing, while protecting normal tissues. It is also directly cytotoxic to selected neoplastic cell types, without associated toxicities to normal cell function. 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.