PharmaDrug Inc announced that interim positive findings from its ongoing prostate efficacy study have demonstrated that the company's enteric coated, oral formulation of cepharanthine (PD-001), when combined with cabazitaxel, significantly reduces tumor volume and provides improved prostate cancer tumor growth inhibition.
These interim results, provided to the company on the final day of study dosing, will be used to strengthen claims in its recently submitted provisional patent application which sets forth claims related to the use of cepharanthine plus cabazitaxel and/or other taxane family members used in combination to treat primary, metastatic and chemotherapy-resistant prostate cancer, PharmaDrug said.
"While esophageal cancer continues to be our main focus with a goal to move towards an FDA clinical trial, we believe that cepharanthine will ultimately show a wider potential use in the treatment of cancers, specifically in combination with the current standard of care,” said Daniel Cohen, CEO of PharmaDrug in a statement. “We will continue to explore cepharanthine's potential therapeutic relationship with existing standard of care chemotherapies."
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In 2021, PharmaDrug initiated a series of 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 an unexpectedly synergistic reduction in prostate tumor cell survival.
The company reported that a once-per-day oral regimen of PD-001, in combination with cabazitaxel provided statistically significant benefit at the scheduled end of dosing (day 21) in its ongoing prostate efficacy study.
Specifically, PD-001 delivered at doses of 3, 9, or 27 milligrams per kilogram per day combined with cabazitaxel (3mg/kg/Q3D or every three days) provided up to a 64% tumor growth inhibition compared to 37% noted for treatment with cabazitaxel alone.
PharmaDrug is focused on advancing the clinical development of an improved and patented enteric-coated oral formulation of cepharanthine (PD-001) to treat responsive cancers and coronavirus (COVID-19).
Compared to generic cepharanthine, PD-001 has been shown in rodent and non-rodent models to possess markedly improved oral bioavailability (more easily absorbed), the company said.
Despite enormous research efforts, metastatic prostate cancer has a five-year survival of only 31%. Through subsequent rounds of refinement to optimize PD-001 dose and dose interval, the company endeavours to develop an efficacious, oral therapeutic add-on option to potentially improve outcomes for prostate cancer patients using SoC treatment.
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