Safe Starting Dose for First-In-Human Studies Defined, Clinical Development Stage Commences
MELBOURNE, AUSTRALIA -- (Marketwired) -- 04/27/17 -- Propanc Biopharma, Inc. (OTCQB: PPCH)(OTCQB: PPCHD) ("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.
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.
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.
KCSA Strategic Communications
Philip Carlson / Elizabeth Barker
Jon Goldberg / Lisa Lipson
Source: Propanc Biopharma, Inc.
Released April 27, 2017