Company Prepares Orphan Drug Designation Application to FDA for Treatment of Ovarian Cancer
MELBOURNE, AUSTRALIA --(Marketwired - August 02, 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
that a broad safety margin to support a safe starting dose for PRP in First-In-Human studies was confirmed after no treatment
related findings were reported by pathologists upon completion of a GLP-compliant 28-day repeat-dose toxicity study with PRP. PRP
is a solution for once daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and
chymotrypsinogen.
"The fact we observed no treatment related findings in the 28-day repeat-dose toxicity study provides strong evidence that PRP
is non-toxic compared to standard treatment approaches and concludes the non-clinical development phase of PRP," said Dr Julian
Kenyon, Propanc Biopharma's Chief Scientific Officer. "We can enter First-In-Human studies with confidence that we can safely
increase dosing levels in patients in the hope of maximizing the exposure of PRP to the tumor sites. All too often we see a
modest extension of life for many sufferers, but often at the expense of great toxicity. We hope that PRP will extend life
meaningfully for cancer sufferers, whilst also improving their quality of life."
Given the Company's recent success in receiving Orphan Drug Designation (ODD) from the FDA for the treatment of pancreatic
cancer, one of the lead indications for PRP, it is also preparing to submit a similar application this month for the treatment of
ovarian cancer, which management believes could also qualify for ODD status. Ovarian cancer is a disease with the lowest survival
rate of all gynecological cancers, making it the seventh most common cause of cancer death in women worldwide. More than 60% of
women present with stage III or stage IV metastasized cancer at the time of first diagnosis and have a five-year survival of less
than 20%. Thus, to date, treatment of ovarian cancer is a challenge and prognosis is rather poor, creating a high unmet medical
need for safe and effective treatment options.
"Receiving ODD from the FDA for the treatment of ovarian cancer is a significant regulatory milestone that we look forward to,
and will be yet another positive step forward with the Company's ongoing efforts to develop effective treatments for metastatic
cancer," said James Nathanielsz, Propanc Biopharma's Chief Executive Officer. "This will reinforce our strategic investment in
PRP, demonstrating progress in developing a potential best-in-class therapy that could transform treatment for patients with
metastatic cancer, where there are limited treatment options. Once the ODD application is submitted, we will then work closely
with the regulatory authorities and our clinical investigators to advance PRP promptly through the next stages of clinical
development."
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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