PharmaDrug Announces Plans for First-In-Human Clinical Study with PD-001 (Enteric-Coated Cepharanthine -2HCL) in Esophageal Cancer

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[{"type":"text","content":"PharmaDrug Announces Plans for First-In-Human Clinical Study with PD-001 (Enteric-Coated Cepharanthine -2HCL) in Esophageal CancerToronto, Ontario--(Newsfile Corp. - February 13, 2023) - PharmaDrug Inc. (CSE: PHRX) (OTCQB: LMLLF) (\"PharmaDrug\" or the \"Company\"), a specialty pharmaceutical company focused on the research, development and commercialization of psychedelics and other naturally-derived approved drugs, is pleased to announce that the Company intends to pursue a first-in-human study of its lead development candidate, PD-001, enteric coated cepharanthine-2HCL (for oral administration), in Australia during the second half of 2023.\"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,\" said Daniel Cohen, CEO of PharmaDrug. \"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 U.S. We believe that this cost-efficient strategy will greatly enhance the value of our company for our investors.\"The proposed 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. The Company's decision to pursue clinical development of PD-001 for esophageal cancer initially in Australia derives from a streamlined regulatory framework established by Australia's Therapeutic Goods Administration (TGA) that permits a sponsor to bypass the lengthy and costly process of filing an IND application that would be required by the FDA, while also allowing a sponsor to evaluate its investigational drug prior to committing to larger clinical studies in the U.S. and Europe. In addition to the world-class facilities and deep clinical trial expertise located in Australia, the Company intends to take advantage of Australia's Research and Development (R&D) tax incentive program which will provide the Company with up to a 43.5% refund on all R&D expenditures. Strict adherence to guidelines set forth by TGA ensures that the Company's clinical trial data will be acceptable to other regulatory bodies including the FDA. For the Company, hu...

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