Iron functionalized silica as oral phosphate binder to treat hyperphosphatemia

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R41DK094571-01
Agency Tracking Number: R41DK094571
Amount: $299,741.00
Phase: Phase I
Program: STTR
Awards Year: 2012
Solicitation Year: 2012
Solicitation Topic Code: NIDDK
Solicitation Number: PA11-097
Small Business Information
DUNS: 25852616
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 (503) 418-9306
Business Contact
Phone: (503) 418-9306
Research Institution
3181 SW Sam Jackson Pk Rd
PORTLAND, OR, 97239-
 () -
 Nonprofit college or university
DESCRIPTION (provided by applicant): Hyperphosphatemia is universal to end stage chronic kidney disease patients and a majority of dialysis patients totaling of 400,000 in the US and 2 million worldwide. Current oral phosphate binders to treat hyperphosphatemia still have many drawbacks, including a high risk of calcification, high costs ( 2100- 6500 per patient a year), low-to-moderate efficacy, gastrointestinal adverse effects, and high pill burdens (500-800 mg tablet, 3-12 tablets a day). These lead to low pill compliance, a major reason why patients fail to manage their hyperphosphatemia, which can be fatal. To address the medical need, PDX Pharmaceuticals, LLC is applying for an STTR Phase I grant for the development of a novel oral phosphate binder. Although this class of drugs generates ~ 1.4 billion USD a year in 2009 revenues, new RandD in search for the better drugs is lacking, lagging behind the state of technology. Innovation in this project lies in the utilization of our nanotechnology and ligand design expertise to revolutionize oral phosphate binders. Our goal is to develop a next generation drug with reduced costs, increased patients' compliance (by lowering pill burden and gastrointestinal side effects), and reduced drug associated risks. This Phase I project will involve bench-scale formulating of our iron functionalized silica (Fe-SAMMS), followed by efficacy and safety evaluations both in vitro and in rodent models against the standard of care drugs. Our preliminary studies show that Fe-SAMMS has a phosphate binding ability that is not dependent on pH or other competing anions relevant to gastrointestinal tract, is composed of benign chemicals including silica, iron, and, ethylenediamine- polysiloxane, and is virtually not soluble or absorbed to the body when tested in renal failure rats. SAMMS is readily scaled up within an existing manufacturing base, has a long shelf-life of over 8 years, and low production costs. This project will be a collaborative work between PDX Pharmaceuticals (an OHSU spin-off company) for material development and optimization, and OHSU for in vivo efficacy and safety evaluations by exploiting state of the art animal facilities and clinical expertise at OHSU. Results will lay a foundation for Phase II, intended forlarge-scale GMP production of the Fe-SAMMS, and its GLP safety evaluation toward the IND filing. Our strong team consists of the innovator and developer of SAMMS for metal capture in humans (Yantasee); an Associate Professor of OHSU (Gruber, MD), who has along track record of drug evaluations in animals and moving drugs through the FDA processes; the former Chair of the Nephrology of the American Board of Internal Medicine (Anderson, MD); and a partner at Battelle Ventures (Warren), who specializes in commercialization of health and life science technologies coming out of Battelle's operated National Laboratories. We enjoy strong support from Battelle-PNNL and OHSU who co-own the IP right to be licensed to us, and the Oregon Nanoscience and Microtechnologies Institute (ONAMI), who is about to grant us initial gap funding for commercialization of this technology. Therefore, we fully anticipate a high chance of success for this project. PUBLIC HEALTH RELEVANCE: We propose to develop a novel calcium-free oral phosphate binder to treat hyperphosphatemia in end stage chronic kidney disease patients. The new drug is aimed to have higher efficacy, less pill burden, lower costs, and less adverse effects, resultin in higher pill adherence than the current drugs.

* Information listed above is at the time of submission. *

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