MELBOURNE, Australia, Sept. 17 /PRNewswire-FirstCall/ -- Phosphagenics
Limited (ASX: POH, AIM: PSG, OTCQX: PPGNY) 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
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
SOURCE Phosphagenics Limited