A new compound Antroquinonol® for the treatment of multiple forms of cancer has been proven in vivo. The compound has passed in-vivo efficacy, ADME/toxicology for at least three kinds of cancer (NSCLC, liver and breast cancer) compared with the chemotherapy drugs Mitomycin and Taxol as positive control. No drug resistance was observed during in vivo studies. This indicates that the drug can be considered a long-term orally-administered cancer therapy.
A cGMP production facility to manufacture Antroquinonol® API at pilot-scale quantities has been completed, with a larger manufacturing plant under construction which will cater for expected clinical trial and commercialization demands. We are currently also investigating using transgenic methods to produce the drug as a possible cost-reducing manufacturing technique.
Toxicology studies completed to date have shown toxic effects present only after administration of 30-50 times effective dosage. Such symptoms include diarrhea and non-systemic toxic reactions. Compared to other anti-cancer drugs on the market, Antroquinonol® is the only such natural compound that does not elicit side effects.
PD/PK studies have shown that Antroquinonol® bioactivity begins immediately upon being absorbed through the mucosa, allowing for convenient oral administration. Furthermore, studies have shown that the drug does not remain in the body after a period of 13-15 hours.
From NCE discovery until the applying of US FDA IND filing is expected to take only one and a half years. As such, Antroquinonol® is expected to be backed by a particularly long period of patent protection, not only for cancer disease therapy but also in the autoimmune diseases therapy field.
