Phosphagenics moves step closer to a share of $1billion anti-flammatory drug market
Phosphagenics (ASX: POH) will move a step closer to getting a share of the $US 1 billion anti-flammatory drug market when it starts a Phase 2/3 trial of its patented TPM delivery system with diclofenac in the first quarter of 2010. The successful completion of the Phase 1B trial this week demonstrated that Phosphagenics’ TPM delivery system was able to safely deliver a significantly greater amount of diclofenac into the skin compared other leading commercial products. Diclofenac is one of the leading products of a class of drugs known as NSAIDs (non-steroidal anti-inflammatory drugs).It is used to reduce inflammation and pain associated with inflammation of tendons or joints (tendonitis or arthritis) and acute injuries, such as sport injuries. In the Phase 1B trial, diclofenac absorption was assessed by tape stripping, a standard, non-invasive procedure used to measure the amount of a diclofenac or other drugs found in the various layers of the stratum corneum, the outer layer of the skin. The trial clearly demonstrated that the TPM/diclofenac formulation had a quicker onset and greater magnitude of diclofenac delivery than other competitive products, with increased delivery maintained for at least six hours, the duration of the trial. The company is in the process of designing the parameters of the study and preparing the paperwork required to initiate an efficacy trial during Q1 2010. The human study will assess the efficacy of TPM/diclofenac for the reduction of pain in selected relevant indications such as arthritis or sports injuries. The company is also in the process of preparing an IND package for filing with the US FDA. The company aims to submit its IND application in Q1 2010. It has already received commercial enquires for this product and believe that the most recent results will further commercialisation discussions.
Phosphagenics buoyed by success of oxycodone patch trial for drug delivery
Phosphagenics (ASX: POH) has successfully completed a Phase 1 clinical study of its patented oxycodone transdermal matrix patch system used for sustained release of pain management drugs. The results of the trial established that after a single dose, the patch delivered oxycodone into the blood stream in a reproducible, consistent, and sustained manner. The profile of the oxycodone patch appears potentially very suitable for chronic pain management, according to the study report. After a dose of oral oxycontin pain relief is provided for only a matter of hours. The use of Phosphagenics’ oxycodone patch may provide sustained drug delivery for a matter of days, thus removing some of the peaks and troughs of pain relief associated with oral treatment With sales exceeding $US1.5 billion annually, oxycodone, an opioid derivative, is one of the world’s leading drugs for pain management. Chief operating officer of Phosphagenics Dr Esra Ogru said the oxycodone Phase 1 trial results are a world first and represent the potential of a significant breakthrough in the treatment of chronic pain. He said the company is developing a treatment regime that will lead to therapeutic pain reduction and provide clinicians with more flexibility for treating patients, he said. The company’s next trial, scheduled to be completed before the end of this year, will involve a repeat daily dosing study and will examine oxycodone blood levels over a longer period. Although oxycodone is more potent than morphine, it produces less adverse side effects. Currently the drug can only be administered orally or intravenously. Phosphagenics aims to become the first company to offer chronic pain sufferers, such as cancer patients, an oxycodone gel or patch that will provide sustained pain relief.
(20min delay)