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Phosphagenics Limited today announced positive results of its Phase 1 clinical trial that showed its delivery technology, TPM, delivered leading pain-relief drug oxycodone through the skin without causing any disruption or irritation
MELBOURNE, Australia | December 17, 2007 | Phosphagenics Limited (“Phosphagenics”) (ASX: POH, AIM: PSG, OTCQX: PPGNY) todayannounced positive results of its Phase 1 clinical trial that showed its delivery technology,TPM, delivered leading pain-relief drug oxycodone through the skin without causing anydisruption or irritation.
Dr Esra Ogru, Executive Vice President of Research and Development at Phosphagenics,said these results support Phosphagenics’ aims to be the first to commercialise a sustainedreleaseoxycodone patch for the management of chronic pain.
“Oxycodone, with worldwide annual sales of more than $US 1 billion, is more potent thanmorphine with fewer adverse effects; however, oxycodone is not available transdermally dueto serious issues relating to skin sensitisation and irritation,”
Dr Ogru said.“Our trial results show that TPM can deliver oxycodone through the skin in a sustainedreleaseformulation without causing skin irritation.This trial, which was conducted by CMAX (an independent clinical research organisationlocated at the Royal Adelaide Hospital) was a single-centre, single-blinded, pharmacokinetictrial in 16 healthy subjects. The trial endpoints were to evaluate the safety and tolerability ofthe TPM/Oxycodone formulation and the ability of the TPM technology to deliver oxycodoneinto the body.
The oxycodone, administered as a single transdermal application, was safe with no adverseevents reported. Oxycodone was detected in the subjects for at least 48 hours. The resultsdemonstrate that the formulation is bioavailable and effective in delivering oxycodone into thebody.A collaborative program is now under way with a world leading patch development companyto incorporate the current formulation into a patch system. Plans are also underway toundertake a pivotal clinical study in the first half of 2008.
Dr Esra Ogru said that developing its pain relief pipeline builds on the success of previous transdermal clinical trials and provides a platform for the development of many otherproducts.Mr Harry Rosen, President and CEO said: “Completing this Phase 1 trial was an importantmilestone for our pain management program. We are delighted to have successfully completed this trial and look forward to progressing to the next phase”.
About the trial
Objectives:The primary objective was to evaluate the tolerability and safety of a single 200mg dose ofoxycodone formulated with the TPM delivery technology (TPM/Oxycodone) appliedtransdermally. The secondary objective was to assess the pharmacokinetics ofTPM/Oxycodone.
Trial Design:The trial was a single centred, single blinded, placebo-controlled trial which assessedTPM/Oxycodone in 16 healthy subjects.
Trial Duration:5 days
ResultsThe primary endpoint of safety and tolerability was met as there were no unexpectedadverse events. The detection of oxycodone in the urine of subjects demonstrated that theTPM formulation is bioavailable and effective in delivering oxycodone into the body.
About Phosphagenics Limited
Phosphagenics is a Melbourne-based, globally driven biotechnology company focused onthe discovery of new and cost effective ways to enhance the bioavailability, activity, safetyand delivery of proven pharmaceutical and nutraceutical products.Phosphagenics’ core technology is built around the science and application ofphosphorylation, a process where the addition of a phosphate group has been found toenhance the bioavailability, activity and safety of existing pharmaceuticals andnutraceuticals, as well as to assist in the production of drug delivery platforms.Phosphagenics’ shares are listed on the Australian Stock Exchange (POH) and the LondonStock Exchange’s Alternative Investment Market (PSG). An ADR – Level 1 programwas established in the U.S. with The Bank of New York Mellon (PPGNY) for U.S. investors totrade in Phosphagenics’ stock on the ‘over-the-counter’ market. In July 2007, this wasupgraded to the International OTCQX, a new premium market tier in the U.S. for internationalexchange-listed companies, operated by Pink Sheets, LLC.For more information, please visit Phosphagenics’ web site at www.phosphagenics.com
SOURCE: PHOSPHAGENICS
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