Propanc Biopharma Confirms No Treatment Related Findings for PRP in 28-Day Repeat-Dose Toxicity Study
Company Prepares Orphan Drug Designation Application to FDA for Treatment of Ovarian Cancer
MELBOURNE, AUSTRALIA -- (Marketwired) -- 08/02/17 -- 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
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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, Inc.
Released August 2, 2017