PharmaDrug Inc. announced that the company has completed filing a PCT (Patent Cooperation Treaty) application for its lead drug, cepharanthine-2HCL (PD-001) for the treatment of prostate cancer, alone or in combination with standard of care chemotherapeutics, as well as for other indications where the drug has shown efficacy in preclinical studies. This move is expected to build significant value for the Company's investors. Filing of the PCT provides the Company with 18 months to formally elect and pursue patent protection in any of 153 member countries, including countries of strategic interest such as the United States, Canada, Japan and China.

PD-001 is a novel compound with a unique mechanism of action that has shown promising results in preclinical studies for the treatment of a wide range of diseases. These include but are not limited to prostate cancer, colorectal cancer, breast cancer and infectious disease as well as several others. The PCT patent filing will enable PharmaDrug to simultaneously seek protection for its intellectual property in multiple countries worldwide and will support claims related to the use of PD-001 alone or in combination with already approved chemotherapeutic agents.

This is expected to provide a strong competitive advantage and a solid foundation for the commercialization of the drug. The Company's previously commissioned IND-enabling efficacy study demonstrated that a once-per-day oral regimen of PD-001, in combination with standard of care chemotherapy (SoC), cabazitaxel provided statistically significant benefit from day 10 through to the end of dosing (day 21). The degree of tumor growth inhibition improved for those groups receiving the combination of PD-001 and cabazitaxel versus cabazitaxel-alone, suggesting that PD-001 add-on therapy might provide clinically relevant adjunctive care options as an oral medication.

Significantly, PD-001 delivered at doses of 3, 9, or 27 mg/kg/day combined with cabazitaxel (3mg/kg/Q3D) provided up to a 64% tumor growth inhibition compared to 37% noted for treatment with cabazitaxel alone. Addition of PD-001 to the SoC, cabazitaxel was found to improve tumor growth inhibition by 73% compared to cabazitaxel-alone. Study results were deemed to be highly statistically significant, with a p-value less than 0.001 (day 21).

Importantly, addition of PD-001 to cabazitaxel did not notably increase toxicity compared to cabazitaxel alone. The Company previously filed two Provisional Patent applications which support use of PD-001 plus cabazitaxel for primary, metastatic and chemotherapy-resistant prostate cancer.