MELBOURNE, AUSTRALIA / ACCESSWIRE / October 1, 2015 / 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 pancreatic and colorectal cancers, today announced a summary of current activities and recent achievements which will see the Company ready to complete several important milestones in the coming months.
Propanc Raises First $1.2 Million of Potential $4 Million Deal:
Recently, the Company issued a note with a principal amount of $1.2 million to an institutional investor as a bridge financing to a larger, subsequent financing that may have the potential to provide the Company with up to $4.0 million. If both parties proceed, the aggregate deal size will be sufficient to cover current and future research and development activities leading up to the preparation and commencement of human trials for their lead product, PRP.
The Company provided further information regarding this financing in a Form 8-K filed with the SEC on September 29, 2015.
Numerous Preclinical Activities Underway for The Company’s Lead Product, PRP:
Animal efficacy studies in several tumor cell lines are underway for PRP with the Company’s research partner, vivoPharm, in Hershey, PA. The studies are investigating the optimization of the PRP treatment, which are expected to even further improve PRP’s anti-tumor effects compared to the previous pilot studies. The human xenograft orthotopic models (human derived tumors transplanted into immunocompromised mice) will be used to support upcoming regulatory agency meetings and licensing discussions.
Additionally, pharmacokinetic studies are underway in order to generate important information regarding how the two proenzymes in the PRP formulation are metabolized throughout the body. The data generated will provide important information regarding dosing for each of the two proenzymes and therefore optimizing the treatment regimen for PRP in future human studies.
One additional animal efficacy study conducted at vivoPharm has incorporated a mouse tumor transplanted in immunocompetent (immune functioning) mice. Blood and tissue samples harvested from this study are presently being prepared to be sent to Adaptive Biotechnologies in Seattle, WA, to characterize the immune response when compared to untreated and PRP treated mice.
Important Scientific Discoveries Resulting in Additional Patent Applications:
Whilst undergoing cell culture studies investigating the effects and underlying mechanisms of PRP treatment at the University of Jaѐn in Spain, it was recently reported that important scientific observations were made which has been sent to the Company’s patent attorneys for evaluation. Since then, additional experiments have been conducted confirming the initial results.
Coincidentally, results from recent animal studies conducted at vivoPharm in Hershey, PA, have also been sent to the Company’s patent attorneys for evaluation.
The Company’s lawyers are preparing provisional patent applications and are presently waiting on further results from both research partners in order to maximize the strength of each application.
The Company reaffirms its commitment to announcing findings from these recent studies to shareholders at the earliest opportunity, once the patent applications are filed. Management is excited about these results which helps to further establish the Company’s intellectual property portfolio, as a global leader in the field, which they believe has significant implications regarding the commercial potential of PRP as a long term therapy for the treatment and prevention of metastatic cancer from solid tumors.
Preparation for Regulatory Agency Meetings and Initiation of Partnering discussions:
Preparation is underway for planned regulatory agency meetings early next year, where Propanc management is expected to meet with the Federal Institute for Drugs and Medical Devices in Germany (BfArM), European Medicines Agency (EMA) and US Food and Drug Administration (FDA). The scientific advice meetings will be an opportunity to discuss key activities planned for the future development of PRP, including animal safety/ toxicology studies and the proposed clinical pathway for human studies in Phase I and II.
Orphan Drug Designation:
Further, as a result of completing the recent cell culture and animal studies with its research partners, the Company has selected pancreatic cancer as its lead indication for human studies. Given the background development history of PRP, its uniqueness as a potential treatment for pancreatic cancer, and the size of the target patient population for pancreatic cancer, management will seek Orphan Drug Designation for PRP for this indication in each jurisdiction. When a product is designated orphan drug status in a particular jurisdiction, the relevant agency will assist with advising the Company on its development activities, reduce the costs of various regulatory agency submissions and provide market exclusivity for a period anywhere between 7 to 10 years.
Once the scientific advice meetings with regulatory agencies are completed, the Company will engage potential licensing partners to determine their interest in partnering with Propanc as it enters human trials next year.
Evaluation of Overseas R&D tax Schemes and Government Grants:
The Company over a number of years continues to receive an R&D tax refund from the Australian Government for its research and development activities. Since broadening its level of R&D activities all over the world, the Company has decided to undertake a strategic evaluation of countries around the world which fund R&D and where it could potentially qualify for government grants. Management has decided to focus its efforts into researching grants in the US and EU, which could not only reimburse R&D activities undertaken, but could also provide a potential source of financing for future R&D activities for its lead products and research programs.
Plans for Listing on a National Exchange:
The Company’s management team continues to work closely with its advisors and has carefully considered all financing deals presented to ensure any investor is supportive towards the Company’s ambitions for up listing onto a national exchange. If the current institutional investor decides not to proceed with the subsequent financing, management is confident the Company remains an attractive opportunity to investors willing support its plans to up list sometime next year.
“We are extremely pleased with the progress made with our recent financing and R&D activities,” said James Nathanielsz, Propanc’s Chief Executive Officer, “The important, incremental, but necessary steps taken this year, has enabled us to grow in confidence that we are on the right pathway to achieve long term commercial success.”
Propanc aims to fast track the development of proenzyme related oncology products into clinical trials for colorectal and pancreatic tumors, initially. According to Global Analyst Reports, the world market for colorectal cancer is expected to reach $8.8 billion by 2020 and the global pancreatic cancer market is projected to exceed $1.2 billion by 2015.
Propanc is currently focused on developing new cancer treatments for patients suffering from pancreatic and colorectal cancers. Propanc 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. Propanc’s products involve or employ proenzymes, which are inactive precursors of enzymes.