PharmaDrug Inc (CSE:PHRX, OTCQB:LMLLF) revealed that it intends to pursue a first-in-human study of its lead drug candidate cepharanthine-2HCL (PD-001) for oral administration, in Australia during the second half of 2023.
The Toronto-based pharma company focused on the development and commercialization of psychedelics and other naturally derived approved drugs, said the first-in-human study aims to be a “prospective multi-site open label randomized controlled clinical investigation” of the safety, tolerability, and pharmacokinetics of PD-001 in esophageal cancer subjects.
"We are committed to advancing the development of new treatments for patients with esophageal cancer, and we believe that PD-001 has the potential to be a breakthrough therapy," PharmaDrug CEO Daniel Cohen said in a statement.
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"We intend to leverage the benefits of our orphan drug designation and the data generated from the first-in-human clinical study to support planned Food and Drug Administration (FDA) clinical trials in the US. We believe that this cost-efficient strategy will greatly enhance the value of our company for our investors," he added.
The Australia advantage
PharmaDrug said it doing the clinical development of PD-001 for esophageal cancer initially in Australia due to a “streamlined regulatory framework” established by Australia's Therapeutic Goods Administration (TGA). It allows a sponsor to bypass the lengthy and costly process of filing an Investigational New Drug (IND) application that would be required by the FDA. It also allow’s the firm to evaluate PD-001 prior to committing to larger clinical studies in the US and Europe.
In addition to the world-class facilities and deep clinical trial expertise in Australia, PharmaDrug said it intends to “take advantage of Australia's Research and Development (R&D) tax incentive program” which will provide it with up to a 43.5% refund on all R&D expenditures.
Moreover, strict adherence to guidelines ensures that the clinical trial data will be acceptable to other regulatory bodies including the FDA, said the company. The human clinical data generated from Australia would de-risk PD-001's clinical development plan and support investigation of PD-001 in subsequent Phase 2 and confirmatory studies in the US under an IND with the FDA. Significantly, PharmaDrug's PD-001 has already been granted orphan drug designation by the FDA for the treatment of esophageal cancer.
A large Current Good Manufacturing Practice (cGMP) lot of cepharanthine-2HCL has been completed. The company said that “specific test methods” required by the FDA have been developed during the fourth quarter of 2022 to “support the issuance of the certificate of analysis and master batch record.”
Final release testing is ongoing and PharmaDrug plans to transfer this material to its contract manufacturer, Genvion Corporation. Material transfer is planned for March 2023 and once complete, Genvion will execute all necessary ICH-compliant stability testing and forced degradation studies in support of future filings to the TGA and FDA.
Downstream manufacturing efforts needed to produce orally bioavailable PD-001 will also be completed by Genvion, said the firm.
PD-001 is a natural product
Cepharanthine is a natural product, approved for over 70 years in Japan to successfully treat chronic diseases. In clinical research, cepharanthine has exhibited anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic effects. However, historically cepharanthine's low oral bioavailability has been an obstacle.
The company is focused on advancing the clinical development of an improved and patented enteric-coated oral formulation of cepharanthine (PD-001) to treat responsive cancers and COVID-19.
Investors can learn about third-party validated studies which highlight the potential for cepharanthine in treating cancer here.
They can also read about the potential of PD-001 to treat esophageal cancer here.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive