Iron deficiency is frequently encountered in chronic kidney disease (CKD) patients and many other populations. Current oral iron formulations are poorly tolerated. Injectable iron preparations are difficult to administer, costly and have serious adverse reactions. Therefore, a highly absorbable, well tolerated oral iron supplement for the treatment of anemia associated with chronic kidney disease (CKD) is needed to complement erythropoiesis-stimulating agents. Our iron replacement agent will have the following attributes: 1) oral delivery with minimal adverse events, 2) efficient intestinal transit with vascular system entry, 3) liver targeting where the iron is released to normal iron stores and 4) cost-effective manufacture providing savings to the medical economy. Our Phase I SBIR application is designed to synthesize prototype products fitting this description. This will be accomplished by applying the company's nano-technology expertise to develop a stable iron oxide colloid having a surface coating to permit intestinal transport while protecting against bacterial bloom within th gut. Our proposed product is expected to be the first commercially feasible oral iron replacement therapy that can be safely self-administrated by the patient.

Public Health Relevance

This project will develop an oral iron supplement to more effectively treat iron deficient patients, a common occurrence in chronic kidney disease. The advantage of this product will be its low cost and the easy-of-use. This product is expected to be the first commercially feasible method that will allow patients to self-treat iron deficiency.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43DK099853-01
Application #
8581657
Study Section
Special Emphasis Panel (ZRG1-DKUS-G (12))
Program Officer
Bishop, Terry Rogers
Project Start
2013-09-19
Project End
2014-08-30
Budget Start
2013-09-19
Budget End
2014-08-30
Support Year
1
Fiscal Year
2013
Total Cost
$200,625
Indirect Cost
Name
Biopal, Inc
Department
Type
DUNS #
009796223
City
Worcester
State
MA
Country
United States
Zip Code
01603