Business
Propanc Biopharma Undertaking PRP Manufacturing & Development for Human Use
Novel Proenzyme Pharmaceutical Formulation to be Administered by Intravenous (I.V.) Injection in World First, Phase I First-In-Human Study in Advanced Cancer
About this update from Propanc Biopharma, Inc.
[{"type":"text","content":"\nNovel Proenzyme Pharmaceutical Formulation to be Administered by Intravenous (I.V.) Injection in World First, Phase I First-In-Human Study in Advanced Cancer Patients\n\n MELBOURNE, Australia--(BUSINESS WIRE)--\nPropanc Biopharma, Inc. (OTCQB: PPCB) (“Propanc” or the “Company”), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, today announced that the Company is undertaking manufacturing and development of PRP for human use. PRP is the Company’s lead product candidate and is a novel pharmaceutical formulation consisting of two proenzymes to be administered by I.V. injection in a world first, First-In-Human (FIH) study in advanced cancer patients. It is a long-term therapy for the treatment and prevention of metastatic cancer in patients suffering from solid tumors.\n\nTo date, the Company has sourced the two proenzymes from a raw material supplier, where an isolation process for both ingredients have been established and scaled up. The proenzymes are extracted, precipitated and lyophilized (freeze dried by a low temperature dehydration process), serving as the raw materials for GMP (Good Manufacturing Practice) manufacture of the finished drug product. A proprietary purification process has been developed by Propanc and successful scale up of the bulk drug substances has been completed. Over 95% purity for each of the proenzymes was achieved to reach pharmaceutical standard for the final drug product. This reduces impurities, resulting in a more stable product with a longer shelf life, as the active enzymes have the potential to ‘auto-catalyze’ meaning they can potentially self-activate. Therefore, the novel formulation consists of two proenzymes prepared in individual vials ready to be mixed into a solution for I.V. injection for the upcoming Phase I, FIH study.\n\nAccording to Dr. Linda Isaacs M.D., Integrative Cancer Therapies, January 2022, since the turn of the last century, based on the original hypothesis of Professor John Beard from Edinburgh University, the trophoblastic theory and the origin of cancer, numerous physicians have been injecting enzyme preparations into cancer patients with both startling, but also mixed success. One reason was attributed by Beard to the “wide variation” in the quality available enzymes that he believed explained ...