Proactive Investors - PharmaDrug Inc (CSE:PHRX, OTCQB:LMLLF) announced that its majority-owned subsidiary Sairiyo Therapeutics has successfully demonstrated the ability to manufacture clinical GMP manufacturing batches of PD-001, its patented reformulated enteric coated version of orally bioavailable cepharanthine which is being developed as a potential treatment for oncology and infectious diseases.
The company, which has a 51% stake in Sairiyo, said that this achievement will support regulatory filings for a Phase 1/2 clinical study of PD-001 for oncology and infectious diseases with Australia’s Therapeutics Goods Administration.
Sairiyo has commenced working on its regulatory application for this in-human safety trial in Australia.
The manufacturing of product for use in clinical studies is scheduled for the second quarter of 2024.
"We are extremely excited to reach this milestone in the development of PD-001,” Pharmadrug CEO Robert Steen said in a statement.
“We will immediately begin taking the steps required to set up the appropriate infrastructure and partner relationships in Australia for the purposes of a potential human clinical trial. We have already begun to work on an application and expect to be able to submit it to the proper channels in the next quarter."
The manufacturing milestone will also be used to support future filings with the US Food and Drug Administration (FDA), PharmaDrug said.
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.
It owns 51% of Sairiyo Therapeutics, a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through clinical trials and the associated regulatory approval process in the US and Europe.