PharmaDrug Inc revealed positive results from its preclinical study of cepharanthine-2HCl on different types of cancer.
Studies revealed that 20 of the 60 cancer cells lines screened showed at least 50% growth inhibition when exposed to cepharanthine.
What’s more, the study highlighted instances where cepharanthine displayed growth inhibition that was either comparable or superior to current “gold standard” treatments.
READ: PharmaDrug reveals positive results from preclinical cepharanthine study in cancer showing heightened response in cell lines
According to Pharmadrug, the results validate cepharanthine’s potential to treat a variety of cancers such as esophageal, colorectal, liver and skin.
In particular, esophageal cancer cells were the most highly responsive of all 60 cancers examined, the company said. Cepharanthine showed 99.96% growth inhibition at the top concentration tested and displayed nearly 5-times greater potency (at IC50) than cisplatin, a chemotherapy commonly used to treat esophageal cancer, according to Pharmadrug.
Pharmadrug also told investors that the results “provide confidence” in its plan to dedicate resources to advance PD-001 – in which cepharanthine-2HCl is the active pharmaceutical ingredient – through to US FDA investigational new drug (IDA) approval ahead of further Phase 1 and 2 clinical studies.
"We are extremely excited with the results of this study demonstrating the potential of cepharanthine in treating multiple forms of cancer known to commonly escape response through the development of chemoresistance,” Pharmadrug CEO Daniel Cohen said in a statement.
Cohen told shareholders that the firm did not expect to see such significant growth inhibition in difficult-to-treat cancers.
“Cepharanthine is on its way to establishing itself as a once per day, oral anti-cancer therapeutic with a well-established safety profile which will pave the way for an expedited clinical development pathway and future partnering opportunities with pharmaceutical companies.”
Based on the positive study results, Pharmadrug said it planned to file provisional patents covering cepharanthine for specific cancers and will expand orphan drug designations in the US and Europe for certain cancers.
Additionally, it will complete a second, drug combination clinical study in September and pursue FDA IND-enabling animal studies later in the year to support future human studies.
The company plans to start scaling up production of PD-001 in preparation for the first-in-human proof-of-concept clinical trial.
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