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Propanc Completes Pivotal 28 Day Toxicokinetic Study for Lead Product PRP
DOWNLOAD AS PDF October 25, 2016
MELBOURNE, AUSTRALIA -- (Marketwired) -- 10/25/16 -- 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 it completed a 28 day toxicokinetic study to support determination of a safe starting dose in patients as the Company progresses towards clinical trials in 2017 for its lead product, PRP. PRP is a solution for intravenous administration of pancreatic proenzymes trypsinogen and chymotrypsinogen. All animals involved in the study appeared to be doing well, no issues were reported and plasma levels were not impaired over time.
Data from the GLP (Good Laboratory Practice) compliant, 28 day repeat dose toxicokinetic study will form the basis of a clinical trial application in the UK. The purpose of the study was to evaluate the toxicokinetic parameters of PRP following repeated, daily intravenous tail vein administration in rats and to evaluate distribution and bioavailability of the test articles over an extended period. Furthermore, the pharmacological properties and bioavailability of the treatment before and after repeat exposure were also evaluated.
Studies of this type are an important part of the development process for new therapeutic agents prior to clinical testing in humans and was discussed in detail at a recent scientific advice meeting with the Medicines and Healthcare Products Regulatory Agency (MHRA), UK, earlier this year. Data generated from this study will define conditions for a planned 4-week regulatory GLP compliant toxicology study commencing mid-November 2016 with results expected early 2017.
In addition, the Company is on target to file a second orphan medicinal product designation (OMPD) application for ovarian cancer with the European Medicines Agency (EMA) this month. Furthermore, similar orphan drug designation applications will be filed for pancreatic and ovarian cancers with the U. S. Food and Drug Administration (FDA) later this year. As well as satisfying the criteria for OMPD status for ovarian cancer in Europe, management believes that PRP will satisfy the criteria for orphan drug designation for both indications in the United States, where prognosis for patients diagnosed with these diseases are poor and few treatment options are available.
"We are making excellent progress completing these pivotal studies for PRP," said James Nathanielsz, Propanc's Chief Executive Officer. "Preclinical efficacy is well established and the safety studies are pivotal because it provides the rationale for a safe starting dose for patient trials. In addition, we are finalizing our OMPD application for ovarian cancer which we will submit to the EMA very soon. This is the second indication where we are seeking this status in Europe, the first being pancreatic cancer. We will then target the US for both indications. We believe these are important milestones for the future development of PRP."
