PharmaDrug Inc announced that it has filed a US provisional patent application which details the novel synergistic combination of cepharanthine (PD-001) and cabazitaxel on prostate cancer growth inhibition.
The company said that it also set forth claims related to the use of PD-001, cabazitaxel and/or other taxane family members used in combination to treat primary, metastatic and chemotherapy-resistant prostate cancer.
“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,” Daniel Cohen, CEO of PharmaDrug said in a statement. “We will continue to explore cepharanthine's potential therapeutic relationship with existing standard of care chemotherapies."
READ: PharmaDrug initiates manufacturing of PD-001 for clinical programs in rare cancers and COVID-19
In 2021, the company 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 studies revealed that prostate cancer was particularly responsive to cepharanthine, second only to esophageal cancer.
While the potency of cepharanthine on prostate cancer was notable in the context of other common chemotherapeutic agents, here the company reported that the combination of cepharanthine plus cabazitaxel provided an unexpectedly synergistic reduction in prostate tumor cell survival.
A provisional US patent has been filed to protect these findings and the company plans to strategically build out and extend patent protection for PD-001 in the oncology space. Consistent with this, the company has initiated in vivo prostate cancer model studies to examine the synergistic relationship between cepharanthine and cabazitaxel more closely.
PharmaDrug will have one year post filing, or until January 26, 2023, to provide additional supportive data and to potentially modify its existing claim set based on new findings.
During this time, the company said that it plans to also continue with IND-enabling studies directed towards the use of cepharanthine for esophageal cancer; an indication that the Company's PD-001 previously received orphan drug designation for.
According to the American Cancer Society, in 2021 there were approximately 248,530 new cases of prostate cancer and about 34,130 deaths from prostate cancer in the United States, and it is the second leading cause of cancer death in American men.