Компания Propanc планирует запустить в феврале 2027 года первую в мире клиническую фазу 1b для лечения рака

Propanc Biopharma, Inc. (PPCB) announced plans to initiate a world-first Phase 1b first-in-human (FIH) clinical study of PRP in February 2027 for patients with advanced solid tumors. The multicenter, open-label study is expected to enroll up to 50 patients with advanced solid tumors, including pancreatic, ovarian and refractory prostate cancers, across clinical trial centers in Australia. The two-part study will consist of a dose-escalation phase followed by a dose-expansion phase and is designed to evaluate PRP's safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor activity. PRP will be administered as a weekly intravenous infusion on Days 1, 8, 15 and 22 of each 28-day treatment cycle. Treatment may continue until a predefined withdrawal criterion is met. Part A will use a Bayesian Optimal Interval (BOIN) design with backfill to evaluate up to five dose levels and identify the maximum tolerated dose (MTD), if reached, and/or up to two recommended doses for optimization and expansion. Following selection of the recommended dose or doses in Part A, Part B will evaluate safety, tolerability and preliminary antitumor activity in one or more tumor-specific expansion cohorts. Propanc said several workstreams are progressing in parallel to support the planned clinical trial initiation. GMP manufacturing of the finished PRP drug product is underway, with a small-scale technology transfer run completed. Two scale-up runs are scheduled for September, followed by an engineering run planned for late October. The company said raw drug substance supply for PRP formulation has been secured following completion of recent audit and vendor qualification processes. PK method validation has also commenced, while development of an anti-drug antibody assay is underway. In-use stability testing of the finished PRP formulation is scheduled as part of the preclinical and clinical manufacturing preparations. Propanc is also preparing regulatory and ethics documentation for submission to a Human Research Ethics Committee (HREC) in Australia. The package is expected to include the Investigator's Brochure, a briefing document and the clinical trial protocol. The company plans to provide the study documents to investigators at Australian trial sites for feasibility assessment ahead of the planned HREC submission in November 2026. Propanc said the planned Phase 1b study represents a key milestone as PRP advances from years of research and development into human clinical testing. PRP is being developed as a novel approach to preventing cancer recurrence and metastasis by targeting and eradicating cancer stem cells through proenzyme activation. Propanc said its lead product candidate is designed to address underlying drivers of cancer proliferation and spread and has the potential to extend survival and improve quality of life for patients with limited treatment options. The company is developing PRP for chronic diseases, including recurrent and metastatic cancer. Currently, PPCB is trading at $1.00, down 2.91%. For comments and feedback contact: [email protected] Business News September 11, 2026 16:26 ET Consumer prices data was the main news on the economic front in the U.S. this week. In Europe, the latest interest rate decision from the European Central Bank was the focus along with the revised second quarter economic growth data for the euro area. In Asia, the monthly foreign trade data from China drew attention.