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PharmaDrug Provides Development Update of Cepharanthine (PD-001) for Cancer and Infectious Disease
Toronto, Ontario--(Newsfile Corp. - September 14, 2023) - PharmaDrug Inc. (CSE: PHRX) (OTCQB: LML...
About this update from Pharmadrug, Inc.
[{"type":"text","content":"PharmaDrug Provides Development Update of Cepharanthine (PD-001) for Cancer and Infectious DiseaseToronto, Ontario--(Newsfile Corp. - September 14, 2023) - PharmaDrug Inc. (CSE: PHRX) (OTCQB: LMLLF) (\"PharmaDrug\" or the \"Company\"), is pleased to provide an update on the development activities of the Company's patented reformulated enteric coated version of orally bioavailable Cepharanthine (PD-001) as a potential treatment for oncology and infectious disease. The technical transfer and development activities with Genvion Corporation are well-underway in preparation for clinical GMP manufacturing batches of PD-001 to support future filings to Australia's Therapeutic Goods Administration (TGA) and Food and Drug Administration (FDA) in the United States.Robert Steen, CEO and Chairman of PharmaDrug commented, \"With the PharmaTher partnership now in full swing and the product safely in the hands of Genvion, we are excited by the full renewal of the PD-001 program and look forward to significantly advancing the clinical ready batch for in human trials for several potential indications in Australia and ultimately in the United Sates.\"Current development activities include the establishment of analytical testing methods, manufacturing protocols, as well as execution and performance assessment approaches for PD-001 API to enable scale up activities for future clinical research needs. Manufacturing of a feasibility batch to demonstrate capability will occur within this quarter to allow the Company to define its manufacturing process and evaluate material characteristics. In addition, the initiation of stability studies will define product performance and support shelf-life considerations. These studies and data will provide information to confirm manufacturing readiness, which once achieved, will enable the transition to manufacture GMP PD-001 final product from the available GMP cepharanthine 2-HCL API materials. Manufacturing of the final product is scheduled for the first quarter of 2024. These materials will support potential Phase 1 and 2 clinical trials of PD-001 for oncology and infectious diseases. Downstream manufacturing efforts required to produce the orally bioavailable clinical drug product will also be completed by Genvion Corporation. The Company will commence working on a regulatory application to the TGA for an in h...