MELBOURNE, Australia, Sept. 17 PhosphagenicsLimited (ASX: POH, AIM: PSG, OTCQX: PPGNY) today announced that, followingsuccessful preclinical studies, it plans to undertake a Phase 1 transdermaloxycodone clinical trial aimed at providing chronic pain sufferers with asustained-release pain management product.
Phosphagenics has submitted all necessary documents for approval of thetrial, which is to be conducted at CMAX - an independent clinical researchorganization located at the Royal Adelaide Hospital. The trial, which will bein up to 30 healthy volunteers, will evaluate the tolerability and safety ofthe novel transdermal oxycodone. The trial will begin once approval has beenreceived, which is expected within the next six weeks.
The Company is working towards becoming the first to provide chronic painsufferers with a patch that will provide sustained-release of oxycodone intothe bloodstream. Previous clinical trials have demonstrated thatPhosphagenics' patented technologies can effectively deliver opiates throughthe skin without causing any disruption or irritation.
Harry Rosen, Phosphagenics' President and CEO, said: "We have prioritizedoxycodone over morphine in our pain management pipeline as we are incommercial discussions with several companies.
"These companies' commercial interests are focused on the license of atransdermal pain product containing oxycodone."
Dr. Esra Ogru, Executive Vice President of Research and Development atPhosphagenics, said: "Our objective is to address a large unmet need by usingour technology to deliver oxycodone in a sustained-release formulation totreat pain beyond a 24 hour period."
Oxycodone, currently administered in tablet or intravenous form, in aneight to 12 hour formulation, is more potent than morphine with fewer adverseeffects and its worldwide sales exceed $1 billion annually.
About Phosphagenics Limited
Phosphagenics is a Melbourne-based, globally driven biotechnology companyfocused on the discovery of new and cost effective ways to enhance thebioavailability, activity, safety and delivery of proven pharmaceutical andnutraceutical products. The Company's core technology is built around thescience and application of phosphorylation, a process where the addition of aphosphate group has been found to enhance the bioavailability, activity andsafety of existing pharmaceuticals and nutraceuticals, as well as to assist inthe production of drug delivery platforms. Phosphagenics' shares are listedon the Australian Stock Exchange (POH) and the London Stock Exchange'sAlternative Investment Market (PSG). In March 2006, an ADR - Level 1 programwas 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 markettier in the US for international exchange-listed companies, operated by PinkSheets, 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 currentexpectations of future events. If underlying assumptions prove inaccurate orunknown risks or uncertainties materialise, actual results could varymaterially from the Phosphagenics' expectations and projections. Risks anduncertainties include general industry conditions and competition; economicconditions, such as interest rate and currency exchange rate fluctuations;technological advances and patents attained by competitors; challengesinherent in new product development, including obtaining regulatory approvals;domestic and foreign health care reforms and governmental laws andregulations.
SOURCE Phosphagenics Limited