ALUMINUM REMOVAL BY CHELATORS IMMOBILIZED IN HOLLOW FIBER

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$500,000.00
Award Year:
1989
Program:
SBIR
Phase:
Phase II
Contract:
n/a
Agency Tracking Number:
7325
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
Hemex Inc.
143 Windsor Avenue, Buffalo, NY, 14209
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
Clara M Ambrus Md Phd
(716) 883-8382
Business Contact:
() -
Research Institution:
n/a
Abstract
HEMEX, INC. HAS DEVELOPED A HOLLOW FIBER DEVICE WITH IMMOBILIZED CHELATORS FOR THE EXTRACORPOREAL REMOVAL OF TOXIC METALS FROM BLOOD, SPECIFICALLY ALUMINUM (A1). THIS DEVICE, SIMILAR TO A HEMODIALYSIS CARTRIDGE, IS A NOVEL APPROACH TO DETOXIFICATION, WITH UNIQUE ADVANTAGES OVER EXISTING TREATMENTS: (1) THE IMMOBILIZED CHELATOR DOES NOT ENTER THE BLOOD, MINIMIZING THE DANGER OF TOXICITY; (2) THE DEVICE FUNCTIONS WITH EFFICIENCY DUE TO THE LARGE CONCENTRATION OF CHELATOR AND EXTENSIVE CONTACT AREA AND IS SPECIFIC TOWARD A GIVEN METAL ACCORDING TO THE CHELATOR USED; AND (3) BLOOD COMPATIBILITY OF THE HOLLOW FIBERS ASSURES SAFETY OF APPLICATION. THE SAFETY AND EFFICACY OF THE PROPOSED DEVICE ARE PARTICULARLY ATTRACTIVE AS THE CURRENT CHELATOR THERAPY OF AL INTOXICATION HAS POTENTIAL TOXICITY. IN PHASE I, HEMEX, INC. PLANS TO FINALIZE DESIGN OF THE DEVICE BY SELECTING SPECIFIC CHELATORS FOR A1 AND TESTING THEIR EFFICACY IN VITRO, USING BLOOD FROM PATIENTS WITH A1 INTOXICATION. THE MOST EFFECTIVE DEVICE WILL BE FURTHER EVALUATED IN PHASE II IN EXPERIMENTAL ANIMALS TO ASSURE IN VIVO EFFICACY AND SAFETY. THE DEVELOPMENT OF THE OPTIMAL DEVICE WILL LEAD TO AN INVESTIGATIONAL DEVICE EXEMPTION (IDE) AND CLINICAL TESTING IN PATIENTS ON CHRONIC HEMODIALYSIS.

* information listed above is at the time of submission.

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