Propanc Biopharma Provides Shareholder Update for PRP on Current and Future Activities Leading to Commencement of First-In-Human Studies
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August 30, 2017
MELBOURNE, AUSTRALIA -- (Marketwired) -- 08/30/17 -- Propanc Biopharma Inc. (OTCQB: PPCB) ("Propanc Biopharma" or "the Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, today announced that activities relating to the commencement of a First-In-Human (FIH) study are well underway and progress towards the full scale manufacture of the investigational medicinal product (IMP) PRP, which is to be administered by intravenous (I.V.) infusion to late stage cancer patients suffering from solid tumors. The full scale manufacture of PRP is a key step in order to submit the Company's first clinical trial application, expected in early 2018.
"We are very pleased with the progress of the purification and characterization of the two key active components for PRP, trypsinogen and chymotrypsinogen, and we're now moving into the Good Manufacturing Practice (GMP) phase of the manufacturing process, to ensure the IMP meets the strict guidelines for pharmaceutical use in humans," said James Nathanielsz, Propanc's Chief Executive Officer. "As a result of our progress, we are now commencing preparation of the clinical trial application (CTA) for our FIH study with PRP, which includes the investigational medicinal product dossier (IMPD), investigator's brochure (IB) and study protocol. The study will be led by Professor Klaus Kutz, our Chief Medical Officer."
Later in the year, management will also commence preparing for the FIH study by selecting sites for the trials and analytical labs, before later moving into logistics preparation and undertaking site initiation visits, as the Company moves closer to the target date for CTA submission.
"I am satisfied with our recent progress, in particular that we are able to produce suitable quality materials which meets the manufacturing standards for pharmaceuticals for human use," said Professor Klaus Kutz, Propanc's Chief Medical Officer. "Over the last 24 months, we have produced a strong preclinical package to satisfy regulatory requirements, and I look forward to leading the clinical development team, which is very exciting."
In addition to preparation of the regulatory documentation for supporting a clinical trial application, management are also preparing an Orphan Drug Designation (ODD) application to the FDA for the treatment of ovarian cancer. This is in addition to the ODD designation status already received from the FDA for the treatment of pancreatic cancer.
"Both niche orphan drug indications represent the two target patient populations the Company intends to select for future planned Phase II studies. Later, we will look to add to these indications with other common cancer types from solid tumors, as we expand our Phase II studies for PRP," Professor Kutz said.
PRP is a solution for once daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen. Currently progressing towards First-In-Human studies, PRP aims to prevent tumor recurrence and metastasis from solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. Consequently, a report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 Billion by 2020. The Company's initial target patient populations are pancreatic, ovarian and colorectal cancers, representing a combined market segment of $14 Billion predicted in 2020, by GBI Research.
