MELBOURNE, Australia, Feb. 12, 2018 /PRNewswire/ -- 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 progress of the Company
and its R&D activities in 2017 and its forecast for this year, as the Company looks towards commencing a First-In-Human (FIH)
study for its lead product candidate, PRP, a solution for once-daily intravenous administration of a combination of two
pancreatic proenzymes trypsinogen and chymotrypsinogen.
Since the beginning of 2017, the Company has initiated and completed a number of activities, including:
- Filed two Patent Cooperation Treaty (PCT) applications for a cancer treatment and composition of proenzymes for cancer
treatment, respectively. The PCT application for a cancer treatment claims priority from two earlier Spanish patent
applications filed in 2016. The PCT assists applicants in simultaneously seeking protection for an invention in over 150
countries.
- Acceptance of a lead patent application for PRP from the Chinese Patent Office was received.
- A GLP-Compliant toxicity study over a 28-day period was successfully completed, where no treatment related findings were
observed. This concluded the preclinical development phase of PRP and provides a safety margin for a dosage of PRP to be
administered in a First-In-Human study.
- A method for detection of IR dye labelled trypsinogen and chymotrypsinogen in rat plasma was successfully validated. The
assay was deemed to have acceptable precision and accuracy. It was also selective for the two IR dye labelled proenzymes, as
opposed to the unlabelled proenzymes.
- The U.S. Food and Drug Administration (the "FDA") granted Orphan Drug Designation status to PRP for the treatment of
pancreatic cancer. This qualifies the Company for seven-year FDA-administered market Orphan Drug Exclusivity (ODE), tax credits
of up to 50% of R&D costs, potential for R&D grants, waived FDA fees, protocol assistance and possible clinical trial
tax incentives if conducted in the U.S.
- A manufacturing process capable of purifying and stabilizing two active drug substances of the PRP formulation, trypsinogen
and chymotrypsinogen were developed successfully.
- A sandwich ELISA was developed for the determination of a mixture of chymotrypsinogen and trypsinogen in dose formulations
and human serum. Further development work is necessary to validate the method for the analysis of the two proenzymes in human
serum.
As a result of the activities completed in 2017, the Company intends to undertake the following activities:
- Conduct a Scientific Advice meeting with the MHRA in order to prepare an Investigational Medicinal Dossier for PRP, which
will contribute to the preparation of a Clinical Trial Application (CTA) for a First-In-Human study in advanced cancer patients
with solid tumors.
- Scale up GMP manufacture of PRP for human studies.
- Undertake detailed analysis of the two proenzymes (trypsinogen and chymotrypsinogen) and their activated enzyme forms
(trypsin and chymotrypsin) from the PRP formulation by Liquid Chromatography-Mass Spectrometry. It is believed analysis of
these four analytes will provide a better understanding of the bio-distribution of PRP in human blood plasma
(pharmacokinetics). The intention is to develop and validate an analytical method to measure the pharmacokinetics of PRP that
will provide important information for future Phase II clinical studies in pancreatic and ovarian cancer patients.
Currently progressing towards a First-In-Human study, 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 an estimated combined market segment of $14 billion in 2020, according to 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.
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.
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SOURCE Propanc Biopharma