- PharmaDrug (CSE:PHRX) and PharmaTher Holdings (CSE:PHRM) have revealed that their joint venture, Sairiyo Therapeutics, has completed its clinical and regulatory package to evaluate its reformulated enteric-coated version of cepharanthine
- The product is being evaluated as a potential treatment for infectious diseases and oncology in a Phase 1 clinical study in Australia
- Sairiyo’s wholly owned subsidiary in Australia will work with an Australian clinical research unit to submit the package to the Australian Human Research Ethics Committee for approval and for the purpose of conducting the human clinical study
- Shares of PharmaDrug are up 20 per cent to C$0.03 as of 10:52 am ET
PharmaDrug (CSE:PHRX) and PharmaTher Holdings (CSE:PHRM) have revealed that their joint venture, Sairiyo Therapeutics, has completed its clinical and regulatory package to evaluate its reformulated enteric-coated version of cepharanthine (PD-001).
In a news release, the Toronto-based company stated the product is being evaluated as a potential treatment for infectious diseases and oncology in a Phase 1 clinical study in Australia.
Sairiyo’s wholly owned subsidiary in Australia will work with an Australian clinical research unit to submit the package to the Australian Human Research Ethics Committee for approval and for the purpose of conducting the human clinical study.
“With the application package now completed and the corporate subsidiary already set up in Australia, Sairiyo only needs to finalize its agreement with a research hospital in order to submit the application to the relevant regulatory bodies and ethics committees,” Robert Steen CEO of PharmaDrug, said in a statement.
Sairiyo plans to conduct its first-in-human clinical study of PD-001 in Australia to capitalize on drug development incentives that could earn a 43.5 per cent rebate from the Australian Federal Government’s Research and Development tax incentive program.
Once the study is completed, Sairiyo plans to submit an investigational new drug application to the U.S. Food and Drug Administration to begin clinical trials in the United States.
Cepharanthine is a natural product and approved drug that has been used for more than 70 years in Japan to treat acute and chronic diseases. Cepharanthine has shown in clinical trials to exhibit multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic effects.
PD-001 is also patent-protected in the U.S. with an expiration date of March 23, 2036.
PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics and previously approved drugs.
The company owns a 51 per cent interest in Sairiyo Therapeutics while PharmaTher Holdings owns the remaining 49 per cent.
Shares of PharmaDrug (CSE:PHRX) are up 20 per cent to at C$0.03 as of 10:52 am ET.
Shares of PharmaTher Holdings (CSE:PHRM) are unchanged at C$0.265 as of 12:27 pm ET.
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