VANCOUVER, Nov. 3 /CNW/ - Burcon NutraScience Corporation (TSX - BU) ("Burcon" or the "Corporation") announced today the publication of a peer-reviewed manuscript describing a toxicology study of Supertein(TM) canola protein isolate. The toxicology study was conducted to establish the safety of Supertein(TM) canola protein isolate in food and beverage applications and ultimately to support the process of obtaining Generally Recognized As Safe status ("GRAS status") for Supertein(TM) in the United States. The manuscript, titled "A 13-week dietary toxicity study in rats of a Napin-Rich Canola Protein Isolate", has been published in the journal of Regulatory Toxicology and Pharmacology (Regulatory Toxicology and Pharmacology 55 (2009) pp. 394 - 402). Publication of this study is an important step in the process of obtaining GRAS notification for Burcon's Supertein(TM) canola protein isolate.
With the publication of the Supertein(TM) toxicology study now accomplished, Burcon and Archer Daniels Midland Company ("ADM") will proceed to submit the GRAS notification for Supertein(TM) and Puratein(R) to the U.S. Federal Food and Drug and Administration within the quarter. Upon receipt of the notification, the FDA is expected to respond in accordance with the FDA's established timelines which could take up to 180 days.
The consumption of canola/rapeseed products in the Western world is recent and has been largely limited to the use of the oil for cooking and in salads and the use of canola meal as animal feed by the livestock industry. Burcon's technological advances have made possible the production of canola protein isolates suitable for human consumption as ingredients in higher amounts and in a broader range of foods. Besides their inherent nutritional value and low levels of anti-nutritional factors, Burcon's protein isolates possess unique functional properties such as emulsifying and binding characteristics and transparency when added to beverages. Burcon's two canola protein isolates are rich in either cruciferin or in napin, the major canola protein components.
The objective of this study was to evaluate the safety of Supertein(TM), a napin-rich canola protein isolate, when fed as a protein source at various dietary levels to rats for 13-weeks. Luis Mejia, director of scientific and regulatory affairs of ADM, is the primary author of the study. As previously disclosed, the results of the trial confirmed that Burcon's Supertein(TM) canola protein isolate -as produced using Burcon's protein extraction technology - is safe for its intended use in food and beverage applications.
"The publication of the Supertein(TM) toxicology study is a significant step in the GRAS notification process," said Johann F. Tergesen, Burcon's President and C.O.O. "GRAS notification for our canola protein isolates will make them more readily marketable to food and beverage manufacturers."
Scientific studies including toxicology studies evaluating the safety of both Supertein(TM) and Puratein(R) were conducted during fiscal 2008. Based on those studies, Burcon and ADM prepared a dossier of data that included scientific information about canola seed, how canola is grown, handled and processed, Burcon's protein extraction process and finally, the intended uses of Supertein(TM) and Puratein(R) in foods and beverages. A panel of qualified experts in the fields of food safety, toxicology, nutritional sciences, food allergies and pediatric nutrition reviewed the dossier to which the panel also had input and affirmed unanimously that the proteins are safe for their intended uses. In October 2008, Burcon's Supertein(TM) canola protein isolate and Puratein(R) canola protein isolate achieved self-affirmed GRAS status.
To enhance the acceptance of Supertein(TM) canola protein isolate and Puratein(R) canola protein isolate with global food and beverage companies, Burcon and ADM have chosen to pursue GRAS notification for Supertein(TM) canola protein isolate and Puratein(R) canola protein isolate. GRAS notification is a voluntary procedure whereby a company informs the FDA of its determination that the use of a substance is GRAS.
A substance is GRAS notified when, after reviewing the GRAS notification, the FDA responds with a no-objection letter that it is satisfied with the submission.
After pre-consultation with the FDA, Burcon and ADM concluded that they would, prior to submitting the GRAS notification, submit the scientific studies which were incorporated into the GRAS dossier (the toxicology studies) to peer-reviewed journals for publication. The subject of today's announcement is the publication in the peer-reviewed journal of Regulatory Toxicology and Pharmacology of the Supertein(TM) canola protein isolate manuscript. Burcon has previously announced the publication of the Puratein(R) canola protein isolate study which has been published in the peer-reviewed journal of Food and Chemical Toxicology. Now that the Supertein(TM) toxicology study is published, Burcon and ADM will proceed to submit the GRAS notification for Supertein(TM) and Puratein(R) to the U.S. Federal Food and Drug and Administration within the quarter. Upon receipt of the notification, the FDA is expected to respond in accordance with the FDA's established timelines which could take up to 180 days.
Although Burcon and ADM have determined to pursue GRAS notification to enhance market acceptance of Burcon's proteins, Puratein(R) canola protein isolate and Supertein(TM) canola protein isolate are already self-affirmed GRAS and may be marketed and sold for human consumption in the United States.
About Burcon NutraScience
Burcon is a leader in nutrition, health and wellness in the field of functional, renewable plant proteins. Since 1999, Burcon has developed a portfolio of composition, application, and process patents originating from our core protein extraction and purification technology. We are developing the world's first commercial canola proteins, Puratein(R) and Supertein(TM) with unique functional and nutritional attributes, and CLARISOY(TM), a revolutionary soy protein isolate which is 100% soluble and completely transparent in acidic solutions. Our team of highly specialized scientists and engineers work from our own research facility to develop and optimize environmentally sound technologies. To-date, our patent portfolio consists of 95 issued patents in various countries, including 8 issued U.S. patents, and in excess of 200 additional pending patent applications, 72 of which are U.S. patent applications.
ON BEHALF OF THE BOARD OF DIRECTORS
"Johann F. Tergesen"
Johann F. Tergesen
Burcon NutraScience Corporation is publicly listed on the Toronto Stock Exchange under the symbol "BU". For more information on Burcon, visit www.burcon.ca.
This press release contains forward-looking statements that involve risks and uncertainties. These forward-looking statements relate to, among other things, the Corporation's, plans and timing for the introduction or enhancement of our products, statements about future market conditions, supply and demand conditions, and other expectations, intentions and plans contained in this press release that are not historical fact. Our expectations regarding the prospect for future success depend upon our ability to develop and sell products, which we do not produce today and cannot be sold without further research and development. When used in this press release, the words "goal", "intend", "believes", "potential", "expected", "anticipates", "will be", and similar expressions, generally identify forward-looking statements. These statements reflect our current expectations. They are subject to a number of risks and uncertainties. In light of the many risks and uncertainties surrounding the development of a source of protein from canola meal, you should understand that we cannot assure you that the forward looking statements contained in this press release will be realized.
SOURCE Burcon NutraScience Corporation
For further information: For further information: Jade Cheng, Chief Financial Officer, Burcon NutraScience Corporation, (604) 733-0896, (888) 408-7960 toll-free, firstname.lastname@example.org, www.burcon.ca; AXINO AG, Wolfgang Seybold, Investor Relations Europe, AXINO AG, Konigstrasse, 26, 70173 Stuttgart, Germany, Tel. +49-711-25 35 92-40, Fax +49-711-25 35 92-55, email@example.com, www.burcon.net