MELBOURNE, Australia, Sept. 17 /PRNewswire-FirstCall/ -- Phosphagenics Limited today announced that, following successful preclinical studies, it plans to undertake a Phase 1 transdermal oxycodone clinical trial aimed at providing chronic pain sufferers with a sustained-release pain management product.
Phosphagenics has submitted all necessary documents for approval of the trial, which is to be conducted at CMAX - an independent clinical research organization located at the Royal Adelaide Hospital. The trial, which will be in up to 30 healthy volunteers, will evaluate the tolerability and safety of the novel transdermal oxycodone. The trial will begin once approval has been received, which is expected within the next six weeks.
The Company is working towards becoming the first to provide chronic pain sufferers with a patch that will provide sustained-release of oxycodone into the bloodstream. Previous clinical trials have demonstrated that Phosphagenics' patented technologies can effectively deliver opiates through the skin without causing any disruption or irritation.
Harry Rosen, Phosphagenics' President and CEO, said: "We have prioritized oxycodone over morphine in our pain management pipeline as we are in commercial discussions with several companies.
"These companies' commercial interests are focused on the license of a transdermal pain product containing oxycodone."
Dr. Esra Ogru, Executive Vice President of Research and Development at Phosphagenics, said: "Our objective is to address a large unmet need by using our technology to deliver oxycodone in a sustained-release formulation to treat pain beyond a 24 hour period."
Oxycodone, currently administered in tablet or intravenous form, in an eight to 12 hour formulation, is more potent than morphine with fewer adverse effects and its worldwide sales exceed $1 billion annually.
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. The Company's 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). In March 2006, an ADR - Level 1 program was established in the U.S. with The Bank of New York Mellon (PPGNY) for U.S. investors to trade in Phosphagenics' stock on the 'over-the-counter' market. This has now been upgraded to the International OTCQX, a new premium market tier in the US for international exchange-listed companies, operated by Pink Sheets, LLC.
For more information and to view the clinical trial results in full, please visit Phosphagenics' web site at www.phosphagenics.com
Safe Harbor Statement
This press release contains forward-looking statements based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could vary materially from the Phosphagenics' expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations.
Phosphagenics LimitedCONTACT: Harry Rosen, President and CEO, +1-+61 3 9605 5900; or MaryBennett, Investor Relations Manager, +61 3 9605 5907, both of PhosphagenicsLimited; or U.S. Investor and Media: Brian Ritchie, FD, +1-212-850-5683
Web site: http://www.phosphagenics.com/
