Progress 06/01/07 to 01/31/08
Outputs
OUTPUTS: Iron deficiency develops when there is insufficient iron in one's diet. Even in a country as advanced as the United States, 20% of young women are iron deficient. Infants and children, the aging, and people recovering from serious accidents or major surgery also need supplemental iron. A variety of iron compounds have been used to correct iron deficiency. Each of them causes indigestion, nausea, constipation, black stools and fear of cancer, and similar side effects. Some iron (metallic iron, for example) is inexpensive but not bioavailable and is merely excreted without being absorbed by the individual. Through this USDA-sponsored SBIR Phase 1 research, investigators at BioLink Life Sciences, Inc. and Cornell University have shown that soluble ferric pyrophosphate (SFP) has outstanding potential as an iron supplement and food fortificant. In our Phase I project, we used an in vitro Caco-2 cell culture model to compare iron bioavailabilities from various iron fortificants
with that of SFP. Caco-2 cells are a line of human adenocarcinoma cells that can be grown on culture plates. When exposed to iron in the growth media, these cells take up iron in proportion to the concentration of bioavailable iron supplied. Once inside the cell, the iron stimulates cellular production of ferritin. Using a sensitive assay, we measured the concentration of ferritin and used it as an index of iron uptake. The model allows us to compare bioavailabilities of various iron compounds under a variety of conditions. Our data indicated that SFP provides more iron to the cells and is better tolerated than any other iron supplement currently available. This advance in iron nutrition has allowed us to increase our collaborations within Cornell University and to expand our research to investigators at other medical institutions in the U.S. Other companies have expressed interest in commercializing this product. In addition, we have filed a U.S. patent application disclosing a new
iron supplement. All of this support could make this new iron fortificant available to consumers in 2010. As a result of this research, BioLink has contacted six established pharmaceutical companies in the United States to determine their interest in partnering with us for commercialization of this new iron product. Two companies have expressed strong interest in proceeding further. In addition, we have issued press releases to make the general public aware of this breakthrough. Manuscripts for publication are being prepared.
PARTICIPANTS: Dr. Deanna J. Nelson, Principal Investigator at BioLink Life Sciences, Inc., directed the project, supervised test sample preparation and qualification, and worked with the investigators at Cornell University to complete the research. Mr. Walter Holberg, Director of Analytical Chemistry at BioLink, provided analytical support for the project. Dr. Dennis D. Miller, Principal Investigator at Cornell University, directed the Caco-2 cell studies and supervised their completion. He was also instrumental in analyzing the new data, particularly with respect to mechanisms of uptake. Dr. Leanne Zhu, Research Scientist at Cornell University, completed the Caco-2 cell studies and analyzed the data.
TARGET AUDIENCES: The target audiences for the new information provided by this research will be the general public. Those who are iron deficient (for example, women, children, the aging, and those having chronic diseases) will gain especial benefit from the new knowledge. In addition, the USDA and other government agencies dealing with health and nutrition will benefit from the availability of a reasonably priced, highly nutritious new iron supplement and food fortificant.
Impacts
Completion of this SBIR Phase 1 research has disclosed significant new information about a century-old iron compound. The research revealed that soluble ferric pyrophosphate (SFP) is more bioavailable than any currently used iron fortificant. Verification of bioavailability in Phase II human studies will enable provision of SFP to individuals who are vulnerable to iron deficiency. The research has also enabled significant changes in actions by supporting continued study of the bioavailability of SFP in foods. If the data continue to be as supportive as already observed, SFP could become the iron fortificant of choice, both in the U.S. and abroad. Finally, the research may enable changes that will improve the iron fortification of foods. We anticipate that SFP will be a safer iron fortificant; if our expectations are confirmed, SFP could replace more toxic iron fortificants that are widely used today.
Publications
- No publications reported this period
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