PharmaDrug Inc announced a positive research result for its preclinical cancer study which evaluated the effectiveness of cepharanthine-2HCI alone or when used in combination with standard of care (SoC) chemotherapy on four undisclosed cancer types.
The company said that it is now focusing on advancing Investigational New Drug (IND) enabling studies to support future FDA clinical studies in 2022 for cepharanthine (PD-001).
“Moving our research from in vitro (cell culture-based models) into accepted animal models of cancer is a critical step along our path to the clinic. The careful study design has allowed us to reveal non-obvious situations where cepharanthine provides synergistic benefit to existing treatment,” said Daniel Cohen, CEO of PharmaDrug in a statement.
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Cohen added: “These findings will be leveraged to pursue new intellectual property protection and to hopefully provide new treatment options for patients suffering from difficult to treat cancers. Our move toward IND-enabling animal efficacy studies to support future human clinical studies in oncology will be commencing as planned in November."
The Toronto-based company had previously identified a shortlist of 23 cancer types that were highly responsive to cepharanthine-2HCl. Four instances of drug synergy (cepharanthine+chemotherapy) were revealed in the latest drug combination study.
It added that cancer cell types and SoC treatments remain confidential for the purpose of filing subsequent intellectual property.
PharmaDrug has shipped its drug product, PD-001, to the clinical research organization (CRO) in support of the upcoming IND-enabling animal studies. These studies are designed to evaluate PD-001 efficacy, alone and in combination with SoC in two animal cancer models.
The company's prime cancer focus continues to be esophageal cancer for several reasons including the orphan drug designation awarded by the FDA earlier this year. It has also selected a second cancer type to pursue for studies based on multiple considerations including cepharanthine potency, the ability of cepharanthine to provide synergistic benefits with SoC drugs, relative market size/need, and the suitability of available animal models to provide high translation value to the program.
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. In clinical research, cepharanthine has been shown to exhibit multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral, and anti-parasitic effects.
PharmaDrug is focused on the research, development, and commercialization of controlled substances and natural medicines such as psychedelics, cannabis, and naturally-derived approved drugs.