ENTRIA BIOSCIENCES FACES SERIOUS MARKET AND LEGAL OBSTACLES WITH ITS PHARMACEUTICAL RICE

SOURCE: The Center for Food Safety, USA
AUTHOR: Press Release
URL: http://www.centerforfoodsafety.org/VentriaPR4_09_08.cf
DATE: 09.04.2008

Cera Products, Inc. Will Not Market Products That Contain Ventria's Genetically Engineered Rice Compounds

New Law May Prohibit Ventria from Marketing its Lead Drug in Food Products

Washington, D.C., April 9, 2008 - Ventria Bioscience, the California-based developer of genetically engineered pharmaceutical rice, faces new and daunting challenges in efforts to market its ".pharma rice". compounds, reported the Center for Food Safety today. One potential marketing partner has decided not to use Ventria's products, while a provision in the FDA Amendments Act of 2007 prohibits the use of Ventria's leading pharmaceutical compound in food products without a special exemption from the FDA.

The Center for Food Safety (CFS) welcomes the decision by Cera Products, manufacturer of performance drinks for athletes and oral rehydration solutions, to reject use of Ventria's rice-derived compounds in Cera's products. The Maryland-based company recently declared its position in a letter responding to a 2007 CFS report entitled ".A Grain of Caution: A Critical Assessment of Pharmaceutical Rice".

The CFS report assesses a range of concerns associated with Ventria's development of rice genetically engineered as a ".biofactory". for production of recombinant human proteins with putative pharmaceutical properties. The report also stated that Cera Products, Inc. had displayed interest in marketing products containing Ventria's compounds, based on public statements made by Dr. William Greenough, cofounder and scientific advisory board member of Cera Products.

In the letter sent to the Center for Food Safety on February 20, 2008, Cera Products President and CEO Charlene Riikonen affirmed: ".Our company is not 'a likely partner with Ventria,' (as stated on page 22 of your paper), nor are we including or plan to include any GMO rice in our products. We do not know enough about it for one thing, and certainly further research is needed to support any claims as well as issues and concerns regarding the GMO rice".

".We welcome Cera Products' rejection of Ventria's genetically engineered pharmaceutical rice compounds" said Bill Freese, CFS science policy analyst and author of the report. ".Ventria's products have not been adequately tested, may pose risks to consumers, and have not been approved by the Food and Drug Administration. What's more, use of these compounds has not been proven to offer any advantages over existing oral rehydration therapies".

In another setback for Ventria, an amendment to FDA regulations passed by Congress in September 2007 establishes a ".Prohibition Against Food to Which Drugs or Biological Products Have Been Added". Ventria's leading rice-produced compound is recombinant human lactoferrin (rhLf). Another firm producing rhLf in genetically engineered fungus is presently testing it in advanced clinical trials as a potential anticancer drug. Because of the prohibition, Ventria would have to seek a special exemption from FDA to market its rhLf drug as an ingredient in medical foods or other food products.

".This sensible prohibition should stop Ventria's headlong rush to put its unapproved lactoferrin in the food supply" said Joseph Mendelson, CFS legal director. ".FDA has enough problems handling traditional food safety threats, like Salmonella, without allowing people to be exposed to unapproved drugs in foods".

Ventria has proposed to market recombinant human lactoferrin and lysozyme, extracted from its genetically engineered rice, as additives to a variety of products, including yogurt, granola bars and performance drinks, as well as oral rehydration solutions for children suffering from diarrhea.

CFS's 2007 report addresses potential adverse health impacts from consumption of Ventria's compounds, lack of regulatory oversight, ethical issues surrounding a Ventria-sponsored trial on Peruvian infants suffering from diarrhea, and more cost-effective alternatives for prevention and treatment of diarrhea.

For further information on Ventria and its genetically engineered pharmaceutical rice, see the Center for Food Safety's report, ".A Grain of Caution: A Critical Assessment of Pharmaceutical Rice".

http://www.centerforfoodsafety.org/pubs/Pharmaceutical Rice-FINAL.pdf

Cera Products Inc. manufactures and distributes high-performance, proprietary rice-based oral rehydration solutions (ORS) and performance drinks that are available nationally and worldwide. For more information on Cera Products, see http://www.ceraproductsinc.com/.

For the new ".Prohibition Against Food to Which Drugs or Biological Products Have Been Added" see Section 912 of the FDA Amendments Act of 2007, available here.

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_publi...