enteric-coated cepharanthine (PD-001) / PharmaDrug - LARVOL DELTA

PharmaTher’s Sairiyo Therapeutics Receives Approval to Initiate a Phase 1 Human Clinical Trial of PD-001 (Reformulated Cepharanthine) (GlobeNewswire) - "PharmaTher Holdings Ltd...announced today Sairiyo Therapeutics Inc...has received approval by the Australian Human Research Ethics Committee to initiate a first-in-human Phase 1 clinical study (the 'Study') investigating a patented reformulated enteric coated version of oral cepharanthine ('PD-001') as a potential treatment for Medical Countermeasures and cancer."

New P1 trial • Oncology

PharmaTher’s Sairiyo Therapeutics Completes Clinical and Regulatory Package for Phase 1 Study of Patented Reformulated Cepharanthine (GlobeNewswire) - "PharmaTher Holdings Ltd...announced today Sairiyo Therapeutics Inc...has completed its clinical and regulatory package to evaluate Sairiyo’s patented reformulated enteric coated version of orally bioavailable cepharanthine ('PD-001') as a potential treatment for...oncology in a Phase1 clinical study in Australia. Sairiyo's wholly-owned subsidiary in Australia, Sairiyo Therapeutics Australia Pty Ltd., will work with an Australian clinical research unit to submit the clinical and regulatory package to the Australian Human Research Ethics Committee for approval to conduct the human clinical study....Upon completion of the clinical study, Sairiyo intends to submit an Investigational New Drug application for PD-001 to the U.S. Food and Drug Administration (FDA) to commence clinical trials in the United States."

IND • New P1 trial • Oncology

PharmaTher’s Sairiyo Therapeutics Inc. Advances Clinical Development of Patented Reformulated Cepharanthine for Phase 1 Study in Australia (GlobeNewswire) - "PharmaTher Holdings Ltd...announced today Sairiyo Therapeutics Inc...has initiated its regulatory and clinical development plan to evaluate Sairiyo’s patented reformulated enteric coated version of orally bioavailable cepharanthine (PD-001) as a potential treatment for oncology and infectious diseases in a Phase1 clinical study in Australia. PD-001 is protected by US Patent US10576077, with a patent expiration date of March 23, 2036....Manufacturing of product for clinical studies is scheduled for the second quarter of 2024....We expect to submit the regulatory package to the TGA for a proposed Phase 1 clinical study in Australia in Q2-2024."

Commercial • New P1 trial • Non-US regulatory • Patent • Oncology

PharmaDrug advances investigational cancer therapeutic PD-001 toward in human safety trial (Proactiveinvestors) - "PharmaDrug Inc...said it continues to advance its patented reformulated enteric-coated version of orally bioavailable cepharanthine (PD-001) as a potential treatment for oncology and infectious disease with the aim of commencing a regulatory application to the Australian Therapeutic Goods Administration (TGA) for an in human safety trial of the drug in the first quarter of 2024....The company also intends to initiate stability studies to define product performance and support shelf-life considerations. The manufacturing of the final product is targeted for the first quarter of 2024, and this will support potential Phase 1 and 2 clinical trials of PD-001 for oncology and infectious diseases, with the company to commence working on a regulatory application to the TGA for an in human safety trial at that time."

New trial • Oncology

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

New trial • Esophageal Cancer • Gastrointestinal Cancer • Oncology

PharmaDrug Advances Programs in Oncology with Filing of PCT Application Detailing the Use of PD-001 for Treatment of Prostate Cancer (Yahoo Finance) - "PharmaDrug Inc...is pleased to announce that the Company has completed filing a PCT (Patent Cooperation Treaty) application for its lead drug, cepharanthine-2HCL (PD-001) for the treatment of prostate cancer, alone or in combination with standard of care chemotherapeutics, as well as for other indications where the drug has shown efficacy in preclinical studies. This move is expected to build significant value for the Company's investors."

Patent • Genito-urinary Cancer • Oncology • Prostate Cancer

PharmaDrug Announces Positive Findings for the Combination of Cepharanthine and Frontline Chemotherapy for IND-Enabling Esophageal Cancer Study (Yahoo Finance) - "Results from these in vitro studies revealed that of all cancer types screened, cepharanthine displayed the greatest growth inhibition against esophageal cancer....PD-001 delivered at a dose of 27 mg/kg/day combined with paclitaxel provided an improvement of 41% in tumor volume reduction beyond that of paclitaxel alone (day 28 post tumor implantation). This result was found to be statistically significant versus paclitaxel alone (p=0.0049). PD-001 (27 mg/kg/day) tended to provide tumor growth inhibition as early as day 17 post implantation (40% greater than paclitaxel alone), that peaked at day 20 (84% greater than paclitaxel alone)....Animals that had previously received paclitaxel with PD-001 at 27mg/kg/day (combination therapy) demonstrated a weeklong, statistically significant improvement in tumor volume compared to those treated with paclitaxel alone."

Preclinical • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Oncology

PharmaDrug Advances Oncology Program with Filing of Provisional Patent Following Positive Findings for the Combination of PD-001 and Frontline Chemotherapy in Prostate Cancer Study (Yahoo Finance) - "PharmaDrug...is pleased to announce that the Company's enteric coated, oral formulation of cepharanthine (PD-001), when combined with cabazitaxel, significantly reduces tumor volume and provides improved prostate cancer tumor growth inhibition. Accordingly, the Company has filed a second provisional patent application to support new claims specifically related to the in vivo dosing of cepharanthine in combination with taxane-family members for the treatment of prostate cancer....Upon completion of study dosing, PD-001 delivered at doses of 3, 9, or 27 mg/kg/day combined with cabazitaxel (3mg/kg/Q3D) provided up to a 64% tumor growth inhibition compared to 37% noted for treatment with cabazitaxel alone."

Patent • Preclinical • Gastrointestinal Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

Pharmadrug Announces Positive Research Results of Cepharanthine to Treat Multiple Cancers (Yahoo Finance) - “PharmaDrug…announce the completion of their preclinical cancer study which evaluated cepharanthine-2HCl, the active pharmaceutical ingredient in PD-001, the Company's patented oral formulation of cepharanthine. The results from the study validate cepharanthine's potential in treating different types of cancer including esophageal, colorectal, liver and skin…results of the current study demonstrated that esophageal cancer was the most highly responsive of all sixty cancers examined; with cepharanthine showing 99.96% growth inhibition at the top concentration tested and displayed approximately 5-times greater potency (at IC50) than cisplatin, a chemotherapy commonly used to treat esophageal cancer despite the fact that development of chemoresistance to this family of agents is common.”

Preclinical • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Skin Cancer

PharmaDrug Advances Product and Clinical Development of Cepharanthine to Treat Infectious Diseases Including COVID-19 (StockHouse) - "PharmaDrug Inc....has initiated preparation of a Pre-Investigational New Drug Application (pre-IND) for its patented enteric-coated formulation of cepharanthine (PD-001), an oral antiviral pill to treat mild-moderate COVID-19....The Company has already initiated a fair amount of preparation and expects to be in a position to proceed with filing a Pre-IND with the FDA before the end of July to determine the appropriate next steps to advance to human clinical studies..."

FDA event • Infectious Disease • Novel Coronavirus Disease

PharmaDrug Initiates Preclinical Study of Cepharanthine to Both Broaden Its Cancer Scope and to Streamline Its Strategy for Esophageal Cancer (Newsfile) - "PharmaDrug...is pleased to announce that it has entered into a service agreement with a respected contract research organization (CRO) with deep expertise in preclinical oncology model development and drug testing, to evaluate the Company's patented enteric-coated formulation of Cepharanthine ('PD-001') in a broad panel of human cancers..."Our research and development strategy to identify highly probable uses of PD-001 in select cancer indications will allow us to de-risk and accelerate development of preclinical and clinical studies while building core competencies and scientific data for future partnering opportunities with pharmaceutical companies...A planned follow up study will use data generated from the first study to examine the benefit of PD-001 alone (monotherapy) or when combined with relevant first and second-line chemotherapy drugs."

Preclinical • Esophageal Cancer • Gastrointestinal Cancer • Oncology