PharmaDrug Inc has released positive findings of a study of its cepharanthine (PD-001) candidate, which showed that when it is combined with chemotherapy drug paclitaxel, can treat esophageal cancer.
The study showed it to reduce tumor volume and improve the inhibition of tumor growth.
"We are extremely excited to continue to broaden the use case for PD-001 as a treatment for esophageal cancer," said Daniel Cohen, the CEO of PharmaDrug in a statement.
"This study outcome serves to further support our goal of moving towards an FDA clinical trial and will provide the company with the opportunity to fully leverage the benefits of the previously granted FDA orphan drug designation for cepharanthine-based treatment of esophageal cancer," he added.
"We believe that cepharanthine will ultimately show a wider potential use in the treatment of cancers, specifically in situations where chemoresistance becomes an obstacle to optimal outcome."
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A once-per-day oral regimen of PD-001, in combination with paclitaxel, significantly reduced tumor volume and improved tumor inhibition at the scheduled end of dosing, namely day 28 post implantation, noted the drugs firm.
"Following 28 days of paclitaxel administration, tumor volume was reduced by 53% compared to the untreated control group. Significantly, paclitaxel provided robust tumor growth inhibition in the early portion of the study, but during the second half, the rate of tumor growth tended to accelerate," said the firm, adding that this "mirrors" what often happens in the clinical treatment of esophageal cancer patients; with the development of chemoresistance often noted after a period of treatment.
"PD-001 delivered at a dose of 27 mg/kg/day combined with paclitaxel provided an improvement of 41% in tumor volume reduction beyond that of paclitaxel alone (day 28 post tumor implantation). This result was found to be statistically significant versus paclitaxel alone," added the company.
Despite standard, targeted and immunotherapy options, survival from esophageal cancer is dismal, said the company.
The five-year survival rate of people with cancer located only in the esophagus is 47%, while the five-year survival rate for those with disease that has spread to surrounding tissues or organs and/or the regional lymph nodes is 25%.
PharmaDrug's cancer program is based on cepharanthine's known anti-cancer activities. 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.
Contact the writer at giles@proactiveinvestors.com