MELBOURNE, Australia, May 2, 2016 /PRNewswire/ -- Propanc Health Group Corporation (OTCQB: PPCH) ("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, announced today a successful meeting was held with the UK Medicines and Healthcare Products Regulatory Agency, confirming the formal preclinical requirements to commence a first-in-man study with the Company's lead product, PRP. As a result, the Company hopes to submit a clinical trial application (CTA) for late stage cancer patients with solid tumors in the UK, early 2017.
The Company discussed the quality development of PRP, the design of a non-clinical GLP (Good Laboratory Practice) safety toxicology study and the design and response criteria for the planned Phase I study with PRP.
"The discussion with the MHRA was highly productive and confirms our development plans for PRP," said James Nathanielsz, Propanc's Chief Executive Officer. "Significant steps forward with our scientific research, including elucidating PRP's mechanism of action and potent effects against cancer stem cells, as well as important preclinical development activities over the past twelve months, have placed us in a position where we intend to commence patient trials early next year. Whilst this is a reflection of our team's hard work, our immediate attention now turns towards commencing this important non-clinical toxicology study and the GMP (Good Manufacturing Practice) production of PRP for clinical trials. We are excited about entering this next phase of development and believes this a genuine milestone as the Company transforms into a clinical stage development company."
A submitted draft of the meeting minutes is currently being reviewed and a final response from the MHRA will be confirmed in the next few weeks.
As a next step in the development program of PRP, management will now turn its attention towards applying for orphan drug designation for pancreatic and ovarian cancers in the United States and Europe. If achieved, the Company will receive market exclusivity for up to 7 to 10 years, ongoing regulatory advice and discounted fees on regulatory submissions.
"Achieving orphan drug designation will add significant value to our Company and cannot be underestimated. We are excited about the potential qualification of PRP for orphan drug status and plan to submit the applications in the near future," said Mr. Nathanielsz.
The Company aims to fast track the development of proenzyme related oncology products into clinical trials initially for pancreatic and ovarian cancers, followed by colorectal cancer. According to Global Analyst Reports, the combined world market for pancreatic, ovarian and colorectal cancers are expected to reach over $12 billion by 2020.
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
Certain of the matters discussed in this announcement involve risks and uncertainties including, without limitation, those regarding the Company's ability to establish and maintain the proprietary nature of its technology through the patent process, its ability to license from others patents and patent applications, if necessary, to develop certain products, its ability to implement its long range business plan for various applications of its technology, and its ability to enter into agreements with any necessary marketing and/or distribution partners for purposes of commercialization. This is not a solicitation to buy or sell securities and does not purport to be an analysis of the company's financial position. See Propanc's most recent Quarterly Report on Form 10-Q and related 8K filings.
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SOURCE Propanc Health Group Corporation
Released May 2, 2016