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.


FULL DISCLOSURE: PharmaDrug is a client of Canacom Group, the parent company of The Deep Dive. Canacom Group is currently long the equity of PharmaDrug. The author has been compensated to cover PharmaDrug on The Deep Dive, with The Deep Dive having full editorial control. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security.

Video Articles

2026 Could Be Gold’s Biggest Year Yet!? | Ryan King – Equinox Gold

Gold Is Screaming Higher While Currencies Burn | Simon Ridgway – Rackla Metals

We Have the Highest-Grade Antimony Deposit in North America!? | Jim Atkinson -Antimony Resources

Recommended

Canadian Copper Secures $8 Million Lead Order From Ocean Partners As Part Of Larger Funding Round

Northern Superior Expands Philibert With 350 Metre Step Out Testing 1.10 g/t Gold Over 25.5 Metres

Related News

Pharmadrug Completes Super Smart Acquisition, Issues 64.4 Million Free Trading Shares

Pharmadrug Inc (CSE: BUZZ) announced this morning that it has completed its acquisition of Interrobang...

Monday, June 15, 2020, 02:44:06 PM

Is Cocaine Turning The Tide Towards Legalization?

Switzerland is currently reevaluating its stance on drug policy as reports emerge of a groundbreaking...
Wednesday, March 20, 2024, 10:40:00 AM

Khiron Life Sciences Looks To Acquire PharmaDrug’s German Subsidiary For $2.0 Million

Khiron Life Sciences Corp. (TSXV: KHRN) announced today the plan to acquire Pharmadrug GmbH, a...

Tuesday, May 31, 2022, 10:34:00 AM

PharmaDrug Enters Letter Of Intent With Licensed Dealer For Pharma Grade Cocaine

PharmaDrug Inc (CSE: PHRX) is one step closer to commercializing its biosynthetic, pharmaceutical-grade cocaine. The...
Thursday, May 23, 2024, 08:22:42 AM

PharmaDrug Anticipates Biosynthetic Cocaine Commercial-Scale Production In As Little As 12 Months

PharmaDrug Inc (CSE: PHRX) has established a strategic plan to push forward with its intent...
Monday, May 13, 2024, 08:55:00 AM