Navigation Links
GRAS Status Opens Door to U.S. Food Industry
Date:3/18/2008

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

About GRAS

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 intended use.

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 substance.

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 http://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.


'/>"/>
SOURCE Phosphagenics Limited
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Niceware International Announces Licensed Vendor Status with ICCBBA, Inc. to Provide ISBT 128-compliant Software
2. Pharmions Oral Azacitidine Granted Fast Track Status for Myelodysplastic Syndromes
3. GenoLogics Geneus Achieves GeneChip-compatible(TM) Status with the Affymetrix GeneChip(R) Microarray Platform
4. PREOS(R) Granted U.S. Orphan Drug Status for Treatment of Hypoparathyroidism
5. Sequella Lead Drug Compound SQ109 Receives Orphan Drug Status From the US FDA and Orphan Medicinal Product Designation From the European Medicines Agency for the Treatment of Tuberculosis
6. IsoTis Reports Status of Merger Vote
7. Bristol-Myers Squibb and Pierre Fabre Provide Update On Vinflunine Development Status
8. Ganeden Biotech Obtains Self-Affirmed GRAS Status for Probiotic Ingredient, GanedenBC30 (Bacillus coagulans GBI-30, 6086)
9. Strativa Pharmaceuticals, the Proprietary Products Division of Par Pharmaceutical, Provides an Update on Development Status of Pafuramidine and Other in-Licensed Products
10. Schering-Plough Announces New Drug Application for Sugammadex Assigned Priority Review Status by U.S. FDA
11. Cephalon Provides Update on Regulatory Status of the FENTORA Supplemental New Drug Application
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... , ... May 26, 2016 , ... ... by Medistem Panama Inc. at the City of Knowledge in Panama, ... mesenchymal stem cells in the US earlier this year following FDA approval of ...
(Date:5/25/2016)... Bangkok, Thailand (PRWEB) , ... May 25, 2016 ... ... the participation of a Thai delegation at BIO 2016 in San Francisco. Located ... private sector will be available to answer questions and discuss the Thai biotechnology ...
(Date:5/25/2016)... ... May 25, 2016 , ... Scientists at the University of ... tried for mesothelioma may be hampering the research that could lead to one good ... here to read it now. , The team evaluated 98 mesothelioma patients ...
(Date:5/24/2016)... ... May 24, 2016 , ... ... and traumatic injuries, will be accelerated by research at Worcester Polytechnic Institute (WPI) ... of wound healing and tissue regeneration. , The novel method, developed by WPI ...
Breaking Biology Technology:
(Date:3/31/2016)... 31, 2016   ... the "Company") LegacyXChange is excited to release ... soon to be launched online site for trading 100% ... ) will also provide potential shareholders a sense of ... to an industry that is notorious for fraud. The ...
(Date:3/22/2016)... PROVO and SANDY, Utah ... Ontario (NSO), which operates the highest sample volume laboratory ... and Tute Genomics and UNIConnect, leaders in clinical sequencing ... announced the launch of a project to establish the ... panel. NSO has been contracted by ...
(Date:3/15/2016)... , March 15, 2016 Yissum ... , the technology-transfer company of the Hebrew University, announced ... of remote sensing technology of various human biological indicators. ... raising $2.0 million from private investors. ... based on the detection of electromagnetic emissions from sweat ...
Breaking Biology News(10 mins):