SOURCE: Propanc Biopharma, Inc.

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July 27, 2017 08:30 ET

Propanc Biopharma Provides Shareholder Update on R&D Activities for PRP

Company prepares for Clinical Trial Application to be filed in the UK

MELBOURNE, AUSTRALIA--(Marketwired - July 27, 2017) - 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 an update on the significant progress of the Company and its R&D activities, as it looks towards filing a clinical trial application in the UK for its lead product, PRP, a solution for once daily intravenous administration of two pancreatic proenzymes trypsinogen and chymotrypsinogen.

Since successful completion of the 28-day repeat dose toxicity study earlier this year, the Company has focused its efforts on Chemistry, Manufacturing and Control (CMC) activities in order to produce the Investigational Medicinal Product (IMP) for PRP, to be used for the upcoming First-In-Human studies. Activities include:

  • Analytical characterization of the trypsinogen and chymotrypsinogen, recently completed by the Technical University of Munich.
  • Identification and development of manufacturing processes for the two proenzymes for human use.
  • Analytical methods developed for the analysis of the trypsinogen and chymotrypsinogen according to Good Manufacturing Practice (GMP).

Data generated from these activities will be compiled into the Investigational Medicinal Product Dossier (IMPD) later this year. In addition to the IMPD, preparation of an Investigator's Brochure (IB), which summarizes all of the clinical and non-clinical data on PRP, will also commence.

"We are entering an exciting phase in the development of PRP as we head towards First-In-Human studies," said Professor Klaus Kutz, Propanc Biopharma's Chief Medical Officer. "Significant progress has been made over the last few months with the IMP manufacture of PRP. Given that we recently received orphan drug designation status from the FDA for the treatment of pancreatic cancer and have completed all the required non-clinical safety studies to define a safe starting dose for humans, our immediate focus right now is to enter the clinical development phase."

In order to finance these critical activities, the Company continues to receive support from investors. To raise the capital needed longer term, Propanc is confident in attracting further investment into its steadily evolving project.

"Our shareholders have been very committed and observe that the Company is entering an exciting growth phase regarding the development of PRP, in addition to the recent announcement of plans to expand our product pipeline through our POP1 joint research program," said James Nathanielsz, Propanc Biopharma's Chief Executive Officer. "We are working closely with investment advisors on our future plans for long term financing and restructuring the balance sheet, going forward, so we can work towards an up-listing to a national exchange in the future."

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.

To view Propanc Biopharma'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 Biopharma's email distribution list, please click on the following link: http://ir.propanc.com/email-alerts and submit the online request form.

About Propanc Biopharma:
Propanc Biopharma is a clinical stage biopharmaceutical company developing new cancer treatments initially 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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