MELBOURNE, AUSTRALIA, January 4, 2017 -- 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, today announced an update on the significant progress of the Company and its R&D activities in 2016 and its forecast for 2017, as the Company looks towards commencing first-in-man (FIM) studies for its lead product, PRP, a solution for once daily intravenous administration of pancreatic proenzymes trypsinogen and chymotrypsinogen.
Since the beginning of 2016, the Company has initiated and completed a number of activities, including:
• Prepared and submitted four new patents in Australia, Spain and the United States, relating to the dosing, anti-cancer effects and mechanism of action of the two proenzymes against various cancers, and in particular, its effects against cancer stem cells, identified in collaboration with the Company’s research partners. As a result of this exciting research, further patents are expected to be filed in 2017.
• Completion of a 14-day, dose range finding toxicity study in rats, defining a maximum tolerated and feasible dose for PRP in preparation for further toxicity assessment in rodents.
• Conducted a scientific advice meeting with the Medicines and Healthcare Products Regulatory Agency, MHRA, UK, defining the non-clinical and clinical development pathway for PRP.
• Developed and validated a new IR (infrared) dye-labelled detection method for trypsinogen and chymotrypsinogen, suitable to measure whole body bio-distribution as well as assessment of PRP concentrations in blood plasma and tissue samples.
• Completed a 28-day repeat-dose toxicokinetic study in rats, which measures the distribution of the two proenzymes in relation to its toxicity over time. No issues were reported and plasma levels of PRP were not impaired over time by neutralising antibody production.
• Developed an enzyme linked immunosorbent assay (ELISA) method by producing polyclonal antibodies from rabbits for the detection and quantification of the two proenzymes in the PRP formulation in human blood plasma for future clinical trials.
• Executed a manufacturing agreement with AmatsiQBiologicals, in Belgium, and started the development process for the finished product manufacture of PRP for human use.
• Commenced the in-life phase of a GLP-compliant, 28-day repeat-dose toxicity study for PRP in rats, which is expected to help define the safe starting dose in advanced cancer patients for first-in-man (FIM) studies.
As a result of the activities completed in 2016, the Company expects to undertake the following activities in 2017:
• Completion of the GLP-compliant, 28-day repeat-dose toxicity study in rats for PRP.
• Finished product manufacture and release of an intravenous formulation of PRP for clinical trials.
• Validation of the ELISA assay for the analysis of PRP in human blood plasma to measure the distribution over time in patients.
• Preparation and submission of an investigational medicine product dossier application (IMPD) and clinical trial application (CTA) for PRP in the UK, for FIM studies.
• Commencement of FIM studies for PRP, targeting advanced cancer patients (solid tumors).
“We are pleased with the progress of PRP this year, and believe we are entering an exciting growth phase for the future of the Company in 2017 and beyond,” said James Nathanielsz, Propanc’s Chief Executive Officer. “Our expectation is, as Propanc becomes a clinical stage biopharmaceutical company, there will be opportunities to grow and expand our pipeline, as well as working towards generating revenue through partnering our lead product, PRP, which we have already initiated preliminary discussions for, and expect to further these discussions as we generate clinical trial data.”
In addition, the Company submitted two Orphan Medicinal Product Designation (OMPD) applications for pancreatic and ovarian cancers to the European Medicines Agency (EMA). In early November, a meeting was held by the Committee for Orphan Medicinal Products (COMP) where the application for Trypsinogen / Chymotrypsinogen (PRP) for treatment of pancreatic cancer was discussed. Prior to adopting an opinion, the COMP requested further information asking the Company to further elaborate on the available in vivo data under review and the open and uncontrolled nature of the preliminary clinical observations from the compassionate use program administered by Dr Julian Kenyon, at the Dove Clinic, UK. As well as a written response, the Company was invited to an oral explanation in December at the EMA, London.
Company representatives led by Dr Julian Kenyon Chief Scientific Officer and Co-Founder at Propanc, Dr Ralf Brandt, Scientific Advisory Board member at Propanc, and Dr Stefan Blesse, Principal Consultant, Granzer Regulatory Consulting and Services, met with members of the committee for orphan medicinal products (COMP) members representing the European Medicines Agency in December to discuss the OMPD application for pancreatic cancer. After an hour long, detailed discussion of the non-clinical results and patient data from the compassionate use program, the committee members and Propanc representatives agreed to withdraw the Company’s OMPD applications for both indications until further notice.
“Whilst the clinical data generated from this seriously ill patient population are impressive, we agree with the EMA that controlled clinical data from our planned patient trials will further establish the clinical benefits from the intravenous administration of PRP in both pancreatic and ovarian cancer patients. Therefore, we will consider resubmitting our application as soon as we generate data from treatment of either pancreatic, or ovarian cancer patients in our upcoming studies,” said Professor Klaus Kutz, Propanc’s Chief Medical Officer. “The results from these submissions have no influence on our development plans for PRP in 2017 and beyond.”
“We respect the decision of the EMA and I look forward to the opportunity to confirm the clinical benefits of PRP administered once daily, intravenously, at much higher doses, in our upcoming clinical trials,” said Dr Julian Keyon, Propanc’s Chief Scientific Officer. “Through my compassionate use program, we substantially extended the lives of a number of pancreatic and ovarian cancer patients, which is why we are initially targeting these patient populations, where there is a real medical need and few treatment options exist. Overall, I am satisfied with the quality of scientific data presented, which generated interest among the EMA representatives, especially the effects of PRP against cancer stem cells, and its potential as a targeted, anti-cancer stem cell therapy. There is no doubt in my mind we are on the right track towards proving the potential benefits of this innovative and exciting approach for the treatment and prevention of metastatic cancer from solid tumors.”
Before commencing patient trials in the target indications (pancreatic and ovarian cancers), a classical FIM study will be run in advanced cancer patients who no longer respond to approved treatment options, which management expects to commence in 2017. This trial is designed to investigate the safety, tolerability and potential adverse effects of PRP. If a patient with pancreatic or ovarian cancer is included in the FIM study, the resubmission of the OMPD will be considered by Propanc’s management team. The Company is also currently determining whether to proceed with Orphan Drug Designation (ODD) applications in the United States as planned, given the recent passing of the 21st Century Cures Act, and support for small biotech companies developing potential cures for life threatening diseases.
To view Propanc’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’s email distribution list, please email PPCH@kcsa.com with “Propanc” in the subject line.
About Propanc:
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.
