Safe Starting Dose for First-In-Human Studies Defined, Clinical Development Stage Commences
MELBOURNE, AUSTRALIA, April 27, 2017-- Propanc Health Group Corporation (OTCQB: PPCH) (“Propanc” or “the Company”), an emerging healthcare 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 the successful completion of the GLP-compliant, 28-day repeat-dose toxicity study for its lead product, PRP. Importantly, there were no major toxicological findings after administration of PRP by intravenous injection once daily throughout the study period. PRP is a combination of pancreatic proenzymes trypsinogen and chymotrypsinogen in solution, for once daily intravenous administration.
The GLP-compliant study was conducted by the Company’s contract research partner, vivoPharm Pty Ltd, in Melbourne Australia.
“We are delighted to have completed this important milestone, which is pivotal for supporting a clinical trial application in the UK, which we expect to submit later this year,” said James Nathanielsz, Propanc’s Chief Executive Officer. “We have now officially entered the clinical development stage for our lead product, PRP, which represents an exciting new therapeutic approach for the treatment and prevention of metastatic cancer.”
“Now that we have completed the 28-day toxicity study, I believe we have sufficient data to support a safe starting dose for First-In-Human studies, initially targeting patients suffering from solid tumors,” said Professor Klaus Kutz, Propanc’s Chief Medical Officer. “My immediate objective is to assist our manufacturing partner, Q Biologicals, undertake the steps necessary to complete the GMP product manufacture of PRP, which forms a key part of our IMPD (Investigational Medicinal Product Dossier).”
These types of studies are key to the developmental process for new therapeutic agents prior to clinical testing in humans and have been already discussed in detail at a scientific advice meeting with the Medicines and Healthcare Products Regulatory Agency (MHRA), UK, last year.
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. The Company’s initial target patient populations are pancreatic, ovarian and colorectal cancers.
To view Propanc’s “Mechanism of Action” video on anti-cancer product candidate, PRP, please click on the following link: http://www.propanc.com/news-media/video
To be added to Propanc’s email distribution list, please email PPCH@kcsa.com with “Propanc” in the subject line.
About Propanc:
Propanc is developing new cancer treatments for patients suffering from pancreatic, ovarian and colorectal cancers. We have developed a formulation of anti-cancer compounds, which exert a number of effects designed to control or prevent tumors from recurring and spreading throughout the body. Our products involve or employ pancreatic proenzymes, which are inactive precursors of enzymes. In the near term, we intend to target patients with limited remaining therapeutic options for the treatment of solid tumors. In future, we intend to develop our lead product to treat (i) early stage cancer and (ii) pre-cancerous diseases and (iii) as a preventative measure for patients at risk of developing cancer based on genetic screening. For more information, visit: www.propanc.com.
