Propanc (OTC – PPCH)Life Changing Biotech
12 Month Price Target is $.87
SeeThruEquity Initiates Coverage on Propanc Health Group
SeeThruEquity Issues Update on Propanc Health Group Corp (OTCQB: PPCH), Highlighting Recent Financing
SeeThruEquity, a leading independent equity research and corporate access firm focused on small-cap and micro-cap public companies, today announced it has issued an update on Propanc Health Group Corp (OTCQB: PPCH).
The report is available here: PPCH April 2016 Update Note. SeeThruEquity is an approved equity research contributor on Thomson First Call, Capital IQ, FactSet, and Zack’s. The report will be available on these platforms. The firm also contributes its estimates to Thomson Estimates, the leading estimates platform on Wall Street.
“As we have noted in our prior notes on the company, Propanc is pursuing a large market opportunity as it seeks to fast track the development of proenzyme related oncology products. The company first plans to develop clinical trials targeting pancreatic cancer and ovarian cancer, followed by colorectal cancer. The company will be targeting patients with limited therapeutic options for solid tumors, and in the future intends to develop products to treat early stage cancer, precancerous diseases and potentially as preventative treatment for patients at high risk of developing cancer based on genetic screening. According to Global Analyst Reports, the combined world market for pancreatic, ovarian and colorectal cancers are expected to reach over $12 billion by 2020,” commented Ajay Tandon, CEO of SeeThruEquity. “We are maintaining our 12-month price target of $0.87 per share.”
Additional highlights from the update note are as follows:
Propanc progressing towards several milestones
Propanc has several potential milestones ahead as the company advances development of its lead therapeutic candidate, PRP. The company has scheduled a scientific advice meeting with the MHRA (Medicines and Healthcare Products Regulatory Agency), UK, which is expected to occur during April. The meeting will include data from its recent 14-day dose range finding study in rats, which will be used to determine appropriate dosing levels for Propanc’s upcoming 28 day toxicology study. Propanc also expects to file an application for an orphan drug designation in the US and EU for pancreatic and ovarian cancers by the end of 2016. If accepted the designation could allow for an accelerated and less costly time clinical pathway for PRP. Propanc is targeting the commencement of early stage patient trials by the end of 2016/ early 2017. Clearly the dose limiting data and any outcomes form its conversations with regulators could provide additional insight into the how we should view the company’s therapeutic clinical pipeline.
Recent financing to advance pre-clinical studies
On March 21, 2016, Propanc announced the receipt of $1.2mn from an institutional investor for the purpose of fast-tracking its pre-clinical activities. With the investment, Propanc has now received a total of approximately $3.6mn from the institutional investor since the Securities Purchase Agreement, Debenture and Warrant were executed by both parties on October 28, 2015, which SeeThruEquity highlighted in its November 24, 2015 update note on the company. Management has indicated that the funds are intended to support the completion of a 28-day animal safety toxicology study, as well as the development of bioanalytical methods for animals and humans in order to assess the movement of the drug within the body. Propanc also expects recent funding will be used to secure GMP manufacturing and to prepare applications for future patient trials, which Propanc management expects to file later in 2016. The company also announced that it will be in New York for a roadshow from April 28, 2016 to May 4, 2016, during which it will provide an update on its activities. This is likely to include a review of any outcomes with its meeting with the MHRA.
Please review important disclosures on our website at www.seethruequity.com
Propanc, (OTC – PPCH) a biopharmaceutical company organized in Melbourne, Australia, in 2007, has developed a unique drug for the treatment of many types of cancer specifically targeting the process of metastasis. Targeted therapies for metastatic cancer has long been regarded as an important goal in cancer research, as metastasis is the cause of most cancer-related deaths and as no currently approved cancer therapies target metastasis.
Propanc (OTC – PPCH) has developed a blend of naturally-occurring chemicals – PRP – that has now been shown to specifically block or reverse the processes that lead to the development of metastases and their ability to grow and spread further. These chemicals, or proenzymes, are normally manufactured by the pancreas. In fact, the company name Propanc is derived from the words “proenzyme” and “pancreas”. In tests on cancer cells, PRP was able to halt the growth of cancer cells and cause these cells to undergo cell death. It was also able to reverse the process of epithelial to mesenchymal transition, as indicated by specific changes in the proteins made by these cells, including the critical protein E-cadherin.
Finally, PRP was also able to cause malignant cancer cells to transition to more harmless cell types, no longer cancerous. All three of these changes in cancer cells caused by PRP indicate that PRP may be highly effective in the treatment of metastatic cancers of many types. The results of these studies have been published in the peer-reviewed scientific journal Cellular Oncology in July, 2013.
What makes these findings particularly important is that there are currently no FDA-approved drugs specifically targeting metastatic cancer, yet without metastasis, most cancers would not be serious or fatal. Most chemical and radiological therapies for cancer are nonspecific, targeting all growing cells and therefore limiting their usefulness due to the inherent toxicity to normal cells. The demand for more targeted and less toxic drugs that specifically target metastasis is therefore enormous.
Propanc has tremendous potential to change this market upon approval of PRP. It not only specifically targets metastatic cancer cells and the process of metastasis, it is composed of chemcials naturally occurring in the human body and therefore lacking intrinsic toxicity to humans. This means that PRP could be used in a very high dose range, as needed for maximum effectiveness. It would also be less likely to exhibit toxic interactions when used in combination with other drugs.
Propanc, (OTC – PPCH) together with its scientific and oncology consultants, has developed a rational, composite formulation of anti-cancer compounds which together exert a number of anti-cancer actions.
Propanc’s (OTC – PPCH) leading products, PRP and PRP-DCM, are novel, patented suppository formulations based on proteolytic proenzymes, which are inactive precursors of enzymes.
There is a substantial body of literature on the potential utility of both proteolytic proenzymes and enzymes in the treatment of cancer, and Propanc is of the view that its proprietary products PRP and PRP-DCM will provide a potent, multi-pronged attack on cancerous cells.
As a result of positive early indications of the anti-cancer effects, Propanc (OTC – PPCH) intends to progress PRP and/or PRP-DCP along the rigorous, formal non-clinical and clinical development pathway required to obtain regulatory approval to market its proteolytic proenzymes formulation. Propanc intends to undertake development of manufacturing, formal non-clinical studies and then Phase I, II and III clinical trials in order to generate the quality, safety and efficacy data required for regulatory approval. Propanc (OTC – PPCH) hopes that encouraging early results will be replicated in large, controlled clinical trials.
In the near term, Propanc’s (OTC – PPCH) clinical development target is patients with limited remaining therapeutic options for the treatment of solid tumors such as colorectal or pancreatic tumors. The data generated to date suggests that Propanc’s lead product, PRP, is well tolerated, and hence in the longer term, Propanc will be targeting the development of its lead product as a treatment for earlier stage cancer, and also as a preventative for patients at high risk of developing cancer –eg. Those diagnosed with precancerous diseases, or patients identified as being at high risk of developing cancer based on genetic analysis. Before targeting these longer term development targets, as a first step Propanc hopes to demonstrate clinically the potential of its lead product in late stage cancer patients whose treatment options are limited.
Our lead product, PRP, is a novel, patented once daily suppository formulation of proteolytic proenzymes. In limited human testing as outlined earlier, supplemented by laboratory research at the Universities of Bath and Granada on the mechanism of action of the proenzyme mixture, evidence has been obtained which suggests PRP may be effective against a range of solid tumors.
In addition to possibly extending survival, the limited human testing showed no observable severe, or even serious adverse reactions and can be easily self-administered.
Most cancer treatments currently on the market suffer from limitations of excessive toxicity or the development of resistance, limiting the extent to which they can be used chronically to control cancer over the long term. Whilst the clinical findings with PRP are early and subject to confirmation in future clinical trials, these data gathered to date, together with the observation that no evidence has been observed of the development of resistance by the cancer to PRP, suggest that PRP may be suitable for long term, chronic therapy.
Recent work undertaken by Propanc (OTC – PPCH) has focused on maximizing the potential of PRP as a drug suitable for long term maintenance by:
- Enhancing the effects of the proenzyme formulation by selecting additional ingredients at non-toxic dose levels which can augment the anti-cancer activity;
- Building on Propanc’s knowledge of the mechanism of action of proteolytic proenzymes in treating cancer to create additional patent opportunities to further protect Propanc’s competitive position in the field.
Scientific research has focused on developing a novel combination of anti-cancer agents working in combination with proteolytic proenzymes which enhance PRP’s anti-cancer effects. The enhanced proteolytic proenzymes-based formulations combine PRP with at least one of two types of identified compounds considered on the basis PRP’s mechanism of action to synergistically enhance the anti-cancer effects of PRP.
In order to maximize its proprietary knowledge on the use of proteolytic proenzymes in the treatment of cancer, Propanc (OTC – PPCH) is presently undertaking research to identify the mechanism at the molecular level by which Propanc’s proenzyme formulation is acting to cause cancer cell death. A research program has been established with Propanc’s collaborators at the University of Granada to investigate the changes in genetic and protein expression which occur in cancer cells as a consequence to being exposed to Propanc’s proenzyme formulation. The objective of this work is to understand at the molecular level the targets of Propanc’s proenzyme formulation, thereby providing the opportunity for the identification of new, patentable drugs which can be further developed by Propanc, such as synthetic recombinant proteins designed to improve the quality, safety and performance of proteolytic proenzymes used in the proposed formulations.
An additional opportunity for PRP is in the treatment of solid tumor masses by the direct injection of PRP into those tumor masses. In order to achieve this, Propanc is developing an injectable form of PRP which would be suitale for direct injection into tumor masses, the intention being to cause shrinkage of individual problematic tumor masses.
We are developing a long term therapy to prevent tumor recurrence and metastasis, the main cause of patient death from cancer. Our pro-enzyme therapy solves this problem by targeting malignant cancer cells through multiple pathways, creating a long lasting clinical benefit for the patient. PRP has anti-tumor activity, but without severe, or even serious side effects associated with chemotherapy.
- Global demand for effective, safe and easy to administer cancer treatments is increasing rapidly;
- Propanc seeks worldwide regulatory approval in several therapeutic indications targeting tumor types where a medical need is established and few treatment options exist;
- 15 years scientific research and clinical experience from treating patients in the UK & Australia has provided evidence that PRP may be an effective treatment against cancer and warrants further development;
- Propanc is building an IP portfolio around our scientific understanding of the effects of proenzymes in cancer, identifying new formulations, new routes of administration and potential new therapeutic targets.
PRP – Inhibits Critical Pathways for Cancer cell Growth
PRP – Proven Anti- Tumor Activity in Mice
PRP – DCM – Further Enhances Anti-Cancer Activity
PRP – DCM – Significantly Reduces Angiogenesis in Mice
Extensive Drug Development & Clinical Expertise
Mr James Nathanielsz Chief Executive Officer
- Director & C.E.O, Oct ‘07.
- 15 yrs. experience in R&D, Manufacturing & Distribution, including 10 yrs. in oncology
- Bachelor of Applied Science (Biochemistry/Applied Chemistry) & Master of Entrepreneurship & Innovation, Swinburne University, Melbourne, Australia.
Dr Julian Kenyon Chief Scientific Officer
- Co-Founder & Director, Feb ‘08.
- Medical Director of the Dove Clinic for Integrated Medicine, UK, since 2000.
- Bachelor of Medicine & Surgery & Doctor of Medicine , University of Liverpool.
- Primary Fellow of the Royal College of Surgeons, Edinburgh for over 40 years.
Prof. Klaus Kutz Chief Medical Officer
- 15 yrs. experience as consultant in Clinical Pharmacology & Safety in oncology.
- 12 yrs. experience Head of Clinical Pharmacology in 2 multinational pharma companies.
- Specialist for Internal Medicine, Gastroenterology & Clinical Pharmacology.
- Professor of Medicine, University of Bonn, Germany.
Our immediate goal is to receive worldwide regulatory approval in several therapeutic indications for our lead product, targeting tumor types where there is an established medical need and where little or few treatment options exist.
Progressing development: The progressing development of a once-daily proteolytic proenzyme cancer treatment through non-clinical and clinical development, and ultimately, obtaining regulatory approval as an effective, clinically proven therapeutic option.
Multiple mechanisms of action: Unlike many products approved for the treatment of cancer, our treatment exerts multiple effects on cancerous cells which inhibits tumor growth and potentially stops it from spreading throughout the body.
Encouraging data from patient treatment: Scientific research undertaken over the last 15 years and the clinical experience from treating patients in the UK and Australia has provided evidence that PRP may be an effective treatment against cancer, and warrants further development.
Unique intellectual property: We are focusing on building a significant portfolio of intellectual property around our scientific understanding of the effects of proteolytic proenzyme in cancer, identifying new formulations, new routes of administration and potential new therapeutic targets.
- We currently have an exclusive license with the University of Bath (UK).
- Potential clinically proven therapeutic option in long cancer treatment and prevention.
- Multiple effects on cancerous cells to achieve a durable clinical response.
- Encouraging data from patient treatment and scientific research over 15 years.
- Growing demand for new cancer treatments, over 10 million annual deaths by 2020.
Pancreatic & Colorectal Cancers: $9B Global Market
- 4 Target patients with solid tumors, initially colorectal & pancreatic tumors.
- 4 694,00 global deaths, combined, in 2012 (WHO).
- 4 With such a high mortality rate, substantial need for new, clinically proven treatments exists .
- 4 PRP is a reformulation/ drug delivery innovation, likely qualify for 505(b)(2) NDA, capturing attention of potential licensees.
PRP was developed because of the limitation of current cancer therapies. While surgery is often safe and effective, many standard therapies for late stage cancer patients urgently need improvement; with current treatments generally providing modest benefits, and frequently causing significant adverse effects.
Our focus is to provide oncologists and their patients with therapies for metastatic cancer which are more effective than current therapies, and which have a substantially better side effect profile.
Propanc (OTC – PPCH) is currently completing non clinical studies and intends to undertake Phase I, II and III clinical trials to assess the safety and efficacy of our product in specific patient populations.
New & Innovative Products for Global Markets
- Build our intellectual property portfolio, seeking patentable discoveries.
- Seek approval of products in all major pharmaceutical markets.
- Aggressively pursue protection of our technology worldwide.
- Acquire products or services that complement our future goals.
Stock Quote: Propanc (OTC – PPCH)
- Propanc Identifies Potential Patent Opportunities
- Propanc Up-lists to OTCQB; Reduces Authorized Shares by 80%
- Propanc Identifies Positive Signals for Efficacy from Pilot Animal Studies
- Propanc Enters into Research Agreement with Adaptive Biotechnologies
- Boehringer Ingelheim Executive Joins Propanc’s Scientific Advisory Board
- Propanc Provides Shareholder Update
- Propanc Settles Two Outstanding Convertible Debts
- Propanc Briefs Investors at the SeeThruEquity 4th Annual Investor Conference
- SeeThruEquity Initiates Coverage on Propanc Health Group with a Price Target of $1.52
- Propanc Announces Latest Company Initiatives
Current drugs in the market offer, at most, a few months of extra life or tumor stabilization.
Studies are revealing the genetic changes in cells that cause cancer and spur its growth and are providing scientific researchers with dozens of molecules, or “targets” that drugs could block. Tumor cells, however, can develop resistance to drugs. Some experts believe that drugs that kill most tumor cells do not affect cancer stem cells which can regenerate the tumor (e.g. chemotherapy).
We are developing a therapeutic solution for the treatment of patients with advanced stages of cancer targeting solid tumors, which is cancer that originates in organs or tissues other than bone marrow or the lymph system. Common cancer types classified as solid tumors include lung, colorectal, ovarian cancer, pancreatic cancer and liver cancers. In each of these indications, there is a large market opportunity to capitalize on the limitations of current therapies.
We believe that our treatment will provide a competitive advantage over other treatments available.
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Any statements set forth above that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations and involve certain risks and uncertainties. Forward looking statements include statements herein with respect to the successful development and growth of the Company’s business in the U.S. and abroad, about which no assurances can be given. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s filings with the Securities and Exchange Commission.
The Company’s further development is highly dependent on future medical and research developments and market acceptance, which is outside its control. This Presentation of Propanc was developed by the Company, is intended solely for informational purposes and is not to be construed as an offer to sell or the solicitation of an offer to buy the Company’s stock. This Presentation is based upon information available to the public, as well as information from other sources which management believes to be reliable but is not guaranteed by Propanc as being accurate nor does it purport to be complete. Opinions expressed herein are those of management as of the date of publication and are subject to change without notice
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