Propanc Commences GLP-Compliant 28-Day Repeat-Dose Toxicity Study
MELBOURNE, AUSTRALIA -- (Marketwired) -- 12/22/16 -- 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 commencement of the in-life phase of the GLP-compliant, 28-day repeat-dose toxicity study for its lead product, PRP. PRP is a solution for once daily intravenous administration of pancreatic proenzymes trypsinogen and chymotrypsinogen.
The study is being conducted through the Company's Partner CRO (Contract Research Organization), vivoPharm Pty Ltd, at their accredited laboratories in Melbourne, Australia. Data from the GLP (Good Laboratory Practice) compliant, 28-day repeat-dose toxicity study in rats will form the basis of a clinical trial application in the UK. Completion of the in-life phase is expected in February, 2017, with interim results reported in the first quarter of 2017.
Studies of this type are an important part of the development process for new therapeutic agents prior to clinical testing in humans and the study was discussed in detail at a recent scientific advice meeting with the Medicines and Healthcare Products Regulatory Agency (MHRA), UK, held earlier this year. Results from this study will help to provide a rationale to select a safe starting dose for first-in-man studies expected to commence in 2017.
In addition to the commencement of the GLP-compliant toxicity study, Propanc continues to work with its manufacturing partner, AmatsiQBiologicals, in Gent, Belgium, as it commences the detailed and technical process of preparing a suitable quality finished product for clinical trials. Activities include purification and characterization of the two pancreatic proenzymes, development and validation of analytical methods for quality assurance and stability testing of the final I.V. finished product formulation for PRP.
"We continue to remain solely focused on the development of PRP for our first-in-man studies. Once the 28 day study is completed, we will commence preparation of the clinical trial application in the UK. We are rapidly transforming into a clinical stage biopharmaceutical company, and are entering an exciting phase of development of PRP, a potential breakthrough for the treatment of metastatic cancer from solid tumors," said James Nathanielsz, Propanc's Chief Executive Officer.
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.
Forward-Looking Statements:
All statements other than statements of historical fact contained herein are "forward-looking statements" for purposes of federal and state securities laws. Forward-looking statements may include the words "may," "will," "estimate," "intend," "continue," "believe," "expect," "plan" or "anticipate" and other similar words. Although we believe that the expectations reflected in our forward-looking statements are reasonable, actual results could differ materially from those projected or assumed. Our future financial condition and results of operations, as well as any forward-looking statements, are subject to change and to inherent risks and uncertainties including those regarding our earnings, revenues and financial condition, our ability to implement our plans, strategies and objectives for future operations, our ability to execute on proposed new products, services or development thereof, our ability to establish and maintain the proprietary nature of our technology through the patent process, our ability to license from others patents and patent applications, if necessary, to develop certain products, our ability to implement our long range business plan for various applications of our technology, our ability to enter into agreements with any necessary manufacturing, marketing and/or distribution partners for purposes of commercialization, the results of our clinical research and development, competition in the industry in which we operate, overall market conditions, and any statements or assumptions underlying any of the foregoing. Other risks, uncertainties and factors that could cause actual results to differ materially from those projected may be described from time to time in reports we file with the Securities and Exchange Commission, including our reports on Forms 10-K, 10-Q and 8-K. We do not intend, and undertake no obligation, to update any forward-looking statement contained herein, except as required by law.
Investor Contacts:
KCSA Strategic Communications
Philip Carlson / Elizabeth Barker
propanc@kcsa.com
Media Contacts:
Jon Goldberg / Lisa Lipson
propanc@kcsa.com
Source: Propanc Health Group Corporation
Released December 22, 2016