FULL DISCLOSURE: This content is sponsored by PharmaDrug Inc.

PharmaDrug Inc (CSE: PHRX) has received approval for its majority owned joint venture, Sairiyo Therapeutics, to process with a Phase 1 clinical study in Australia. The trial aims to assess a reformulated version of oral cepharanthine, referred to as PD-001, as a treatment for cancer and medical countermeasures.

The phase 1 study is set to take place in Australia, following an approval by the Australian Human Research Ethics Committee for an in-human clinical study. Once completed in Australia, the research will be used to support a submission to the US Food and Drug Administration for phase 2 and phase 3 clinical trials in the US.

“We are extremely excited to have achieved this significant milestone for PD-001. This is the product of several years of research and development with the aim of unlocking the therapeutic potential of our patented enhanced bioavailability cepharanthine to potentially treat cancers, infectious diseases and viral pandemics,” commented PharmaDrug CEO Robert Steen.

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PD-001 is an enteric-coated orally bioavailable formulation of cepharanthine. The patented drug is intended to treat a variety of acute and chronic diseases. The original version of cepharanthine has been in use for over seven decades in Japan, with the drug showing multiple pharmacological properties such as anti-oxidative, anti-inflammatory, immuno-regulatory, anti-viral, anti-cancer, and anti-parasitic effects.

The original version of the drug however has suffered from low oral bioavailability, which has limited it from realizing its full potential. PD-001, Sairiyo’s patented version of the drug, has been shown in trials with rodents to markedly improve oral bioavailability, meaning the body can more easily absorb the drug. 

The approval for a phase one study follows the company submitting an application back in May 2024.

PharmaDrug last traded at $0.01 on the CSE.

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