PharmaDrug’s Sairiyo To Begin Manufacturing PD-001 For Clinical Trials In Q2
FULL DISCLOSURE: This content is sponsored by PharmaDrug Inc.
PharmaDrug (CSE: PHRX) has seen its joint venture with PharmaTher Holdings (CSE: PHRM) begin to bear fruit. The venture, referred to as Sairiyo Therapeutics, has seen a milestone in the development of Cepharanthine, also known as PD-001.
PD-001 is a version of orally bioavailable cepharanthine, which contains a patented enteric coating that is seen as a potential treatment for oncology and infectious diseases, including COVID-19 and responsive cancers. The coating has been shown to possess improved bioavailability, meaning it is more easily absorbed by the body, in both rodent and non-rodent models. Cepharanthine, which has been used for more than seven decades in Japan for the treatment of acute and chronic diseases, has traditionally been taken intravenously due to low bioavailability.
In terms of development, Sairiyo has completed the technical transfer and development activities necessary to enable the manufacture of PD-001 in clinical GMP batches. This development is expected to support filings with the Food and Drug Administration in the US, as well as the Therapeutic Goods Administration (TGA) in Australia, and is a necessary step to support future clinical trials.
“We are extremely excited to reach this milestone in the development of PD-001. 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,” commented Robert Steen, CEO of PharmaDrug.
Manufacturing of product for clinical trials is expected to occur in the second quarter, which will support potential Phase 1 and Phase 2 trials for oncology and infectious diseases, with the work already underway for a regulatory application to the TFA for human safety trials in Australia.
Stability trials are meanwhile being conducted on the feasibility batch to determine shelf-life.
PharmaDrug last traded at $0.065 on the CSE.
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