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FOR IMMEDIATE RELEASE October 10, 2006. Favourable toxicology results support broadening transdermal morphine (TPM-01/Morphine) clinical program. Melbourne, Australia, 10 October 2006: Phosphagenics Limited (“Phosphagenics”) (ASX: POH; AIM: PSG) announced today the successful completion of large-scale chronic toxicology studies on its patented transdermal morphine formulation, TPM-01/Morphine, and the carrier platform gel technology, TPM-01. The results of this pre-clinical study will form part of a US Food and Drug Administration Investigational New Drug data package for the indication of chronic pain.
In this trial, the TPM-01/Morphine formulation was administered daily for four weeks, at a human equivalent dose of approximately 298 mg/kg/day or 97mg/kg/day. In the animals treated with either TPM-01/Morphine or the TPM-01 gel alone, no treatment-related changes were observed in clinical signs, dermal reactions, body weight, food intake, haematology, clinical chemistry, urinalysis, organ weights or macroscopy and histopathology of the organs and tissues.
These favourable results provide supporting safety data for examining repeat doses of TPM-01/Morphine in humans. Phosphagenics therefore proposes to request an amendment to the protocol of the Phase IIa study announced in May 2006. The proposed amendment is to evaluate repeated doses of TPM-01/Morphine in humans, in contrast to the original protocol which was limited to evaluation of single dose acute application.
This amendment, upon approval by the responsible Ethics Committee, allows for the earlier pursuit of Phosphagenics’ goal to develop TPM-01/Morphine for the management of chronic pain. The chronic pain indication is the larger segment of the pain market and involves administration of repeated doses of analgesics for pain management. Phosphagenics anticipates that the clinical results will be available in early 2007. About Phosphagenics’ Transdermal Carrier TechnologyPhosphagenics’ patented transdermal carrier technology (TPM) utilises natural dermal transport mechanisms to rapidly transport small and large molecules across the skin without disrupting or damaging its surface.
The Company believes that the key advantages of this delivery system includes the fact that it possesses anti-inflammatory and anti-erythema properties, thus minimising skin irritation, and has the ability to provide a sustained systemic delivery of a wide range of drugs – ranging from relatively small molecules (e.g. morphine, fentanyl, oxycodone, atropine, estradiol, testosterone) to large molecules (e.g. insulin and PTH) – from a single application. Additionally, the TPM delivery technology can be cost-effectively manufactured in a wide range of presentations (e.g. gel, paste, liquid and powder) adding value to existing pharmaceuticals.
About Phosphagenics Limited Phosphagenics is a Melbourne-based, globally driven biotechnology company focused on the discovery of new and cost effective ways to enhance the bioavailability, activity, safety and delivery of proven pharmaceutical and nutraceutical products.
Phosphagenics’ core technology is built around the science and application of phosphorylation, a process where the addition of a phosphate group has been found to enhance the bioavailability, activity and safety of existing pharmaceuticals and nutraceuticals, as well as to assist in the production of drug delivery platforms.
Phosphagenics’ shares are listed on the Australian Stock Exchange (POH) and the London Stock Exchange's Alternative Investment Market (PSG). An ADR – Level 1 program has been established in the US with the Bank of New York (PPGNY) for US investors to trade in Phosphagenics’ stock on the ‘over-the-counter’ market.
For more information, please visit Phosphagenics’ web site at www.phosphagenics.com.
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