MELBOURNE, Australia, March 18 /PRNewswire-FirstCall/ -- Phosphagenics
Limited ("Phosphagenics") (ASX: POH, AIM: PSG, OTCQX: PPGNY) today
announced that an independent panel ("the panel") of food safety experts
unanimously concluded that Phosphagenics' patented Phospha E(R) is
Generally Recognized As Safe (GRAS). This comes as a result of the panel
critically evaluating data and information pertinent to the use of Phospha
E(R) in breakfast cereals, juice beverages and table fats.
Phospha E(R) is a patented derivative of vitamin E with superior
qualities, such as greater absorption and activity. In pre-clinical
studies, Phospha E(R), when given orally, has been shown to lower blood
cholesterol and triglyceride levels, inhibit the formation of arterial
plaques and suppress the main inflammatory pathways involved in metabolic
syndrome (a condition which markedly increases the risk of heart attacks,
strokes and diabetes).
The Company is preparing a GRAS notification to inform the U.S. Food
and Drug Administration ("FDA") of the expert panel's conclusion that
Phosphagenics' Phospha E(R) is GRAS. If the FDA has no further comment,
GRAS designation allows manufacturers to produce and sell foods that
include Phospha E(R) in the U.S. food industry.
"GRAS status extends the permitted use of Phospha E(R) beyond the
nutritional supplement market and into the substantial U.S. food industry,
and represents a tremendous commercial opportunity for Phosphagenics," said
Harry Rosen, Phosphagenics' President and CEO.
APPENDIX AND NOTES TO EDITORS
Generally Recognized as Safe (GRAS) is an FDA designation that a
chemical or substance added to food is considered safe by experts, and so
is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA)
food additive tolerance requirements.
GRAS exemptions are granted for substances that are generally
recognized, among experts qualified by scientific training and experience
to evaluate their safety, as having been adequately shown through
scientific procedures (or, in the case of a substance used in food prior to
January 1, 1958, through either scientific procedures or through experience
based on common use in food) to be safe under the conditions of their
The substance must be shown to be "generally recognized" as safe under
the conditions of its intended use. The proponent of the exemption has the
burden of proving that the use of the substance is "generally recognized"
as safe. To establish such recognition, the proponent must show that there
is a consensus of expert opinion regarding the safety of the use of the
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.
Phosphagenics' 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). 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. In July 2007, this was upgraded to the
International OTCQX, a new premium market tier in the U.S. for
international exchange-listed companies, operated by Pink Sheets, LLC.
For more information, please visit Phosphagenics' web site at
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