PharmaDrug Inc has welcomed interim pre-clinical results for its cepharanthine drug, which have validated its ambition to carry out Food and Drug Administration (FDA) investigational new drug (IND)-enabling animal studies for treating esophageal cancer in the fourth quarter this year.
Those studies will examine the efficacy of cepharanthine on its own and when it is combined with standard-of care (SoC) chemotherapy to support Phase 1 and 2 human clinical trials.
In a statement, the pharma group said it had previously identified a short list of 23 cancers that were "highly responsive" to cepharanthine-2HCl and it was recently provided results for 17 of the 23 cells lines being evaluated by an independent contract research organization (CRO).
More than 80% of those short-listed cancers once again displayed sensitivity to cepharanthine-2HCl at, or below levels previously determined to be well tolerated in humans.
READ: PharmaDrug gets pre-IND meeting request granted by US FDA for oral antiviral drug Cepharanthine to potentially treat coronavirus
"Thus far, esophageal cancer continues to be the most responsive of all cancers tested; with cepharanthine-2HCl displaying at least 2-times greater potency for esophageal cancer than the next most sensitive cancer type," said the firm.
Of the 17 cancer cell lines tested, four instances of drug synergy (cepharanthine+chemotherapy) were revealed, it added.
"We are extremely excited about the research results and the potential of cepharanthine to treat various cancers as it allows us to confidently advance our pipeline-in-a-pill strategy for not only infectious diseases, but now also oncology," PharmaDrug CEO Daniel Cohen said in a statement.
"The current results reinforce the potential of cepharanthine as a monotherapy and now also potentially as a synergistic agent when combined with SoC for the treatment of cancer. As such, the primary focus in our oncology program will continue to be esophageal cancer, for which we have already received FDA orphan drug designation. Encouraged by these recent findings, IND-enabling animal efficacy studies to support future human clinical studies in oncology will commence in November."
The firm said it will now expeditiously advance the clinical development of its patented enteric-coated oral formulation of cepharanthine (PD-001) for esophageal cancer.
Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to successfully treat a variety of acute and chronic diseases.
It has been shown in multiple preclinical efficacy models to inhibit cancer cell proliferation, induce cancer cell apoptosis (death) and restore cancer cell sensitivity to multiple unrelated classes of chemotherapy.
PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs.
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