Propanc Successfully Completes Low Dose Group for GLP-Compliant 28-Day Repeat-Dose Toxicity Study

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 low dose group for the GLP-Compliant 28-day repeat-dose toxicity study for its lead product, PRP, and received approval to proceed with the middle and high dose groups from the International Animal Care and Use Committee (IACUC) in Melbourne, Australia. PRP is a solution for once daily intravenous administration of pancreatic proenzymes trypsinogen and chymotrypsinogen.
Significantly, there were no untoward clinical findings throughout the 28-day period, and once-daily dosing by IV injection was successfully accomplished. No treatment related effects were observed in the animals in this study.
“We are very pleased to have successfully completed the first stage of our 28-day study,” said James Nathanielsz, Propanc’s Chief Executive Officer. “There were no clinical observations, nor any adverse effects observed from any of the animals and, in fact, all animals gained body weight within the expected range. The staggering of our dosing groups was required by IACUC in Melbourne, Australia, due to daily dosing of the animals by intravenous (IV) injection, and I am pleased to confirm we can confidently move forward with the second stage of our study, which is expected to be completed in the first quarter of 2017.”
“Given we have now identified a dosing group in the 28-day study with no safety concerns, it gives us great confidence that we are close to defining a safe starting dose for our First-In-Man studies,” said Professor Klaus Kutz, Propanc’s Chief Medical Officer. “Once we complete the 28-day study, we can evaluate results and then start preparing our clinical trial application for submission in the UK this year. This is an important step for the future development of PRP for the treatment and prevention of metastatic cancer from solid tumors.”
These types of studies are important to the developmental process for new therapeutic agents prior to clinical testing in humans as discussed in detail at a scientific advice meeting with the Medicines and Healthcare Products Regulatory Agency (MHRA), UK, last year. Results from the study will help provide a rationale for a safe starting dose for first-in-man studies expected to commence in 2017.
To view Propanc’s “Mechanism of Action” video on anti-cancer product candidate, PRP, please click on the following link: https://www.propanc.com/news-media/video
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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.
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