PharmaDrug Inc (CSE:PHRX, OTCQB:LMLLF) has filed a patent cooperation treaty (PCT) application for its lead drug cepharanthine-2HCL (PD-001) for the treatment of prostate cancer.
Filing a PCT gives the company 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, the company said.
"We are excited to take this important step in the development of PD-001 as a treatment for prostate cancer and other indications,” CEO Daniel Cohen said in a statement. “This PCT patent filing is a significant milestone that will solidify our intellectual property portfolio and provide a clear path for commercialization."
READ: PharmaDrug wraps up key step in production of oral bioavailable version of its oncology and infectious disease drug cepharanthine
Cepharanthine is a natural product, approved for over 70 years in Japan to successfully treat chronic diseases. In clinical research, cepharanthine has exhibited anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic effects. However, historically cepharanthine's low oral bioavailability has been an obstacle.
The PCT 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, the company said.
In 2021, the company-initiated cancer screening studies aimed at uncovering therapeutic opportunities for cepharanthine when used alone or in combination with standard of care (SoC) chemotherapy drugs. Results from these in vitro studies revealed that the combination of cepharanthine and cabazitaxel, a SoC used for castration-resistant, metastatic prostate cancers, provided “unexpectedly synergistic reduction in prostate tumor cell survival.”
A once-per-day oral regimen of PD-001, with cabazitaxel provided a “statistically significant benefit” from day 10 through to the end of dosing (day 21) in its recently completed prostate efficacy study, said the company. Throughout the study period, the degree of tumor growth inhibition continued to improve for those groups receiving the PD-001 and cabazitaxel combo, versus cabazitaxel-alone, suggesting that perhaps a more sustained dosing regimen might result in greater efficacy.
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