Localized Delivery of Sirolimus to Vascular Grafts

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$224,765.00
Award Year:
2012
Program:
SBIR
Phase:
Phase I
Contract:
1R43HL106907-01A1
Award Id:
n/a
Agency Tracking Number:
R43HL106907
Solicitation Year:
2012
Solicitation Topic Code:
NHLBI
Solicitation Number:
PA11-096
Small Business Information
16922 NW HAZELGROVE CT, BEAVERTON, OR, 97006-4821
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
961893893
Principal Investigator:
RONALD SHEBUSKI
(703) 845-5429
rshebuski@gmail.com
Business Contact:
KIM KOWALSKI
(734) 649-6812
finance@k2goblue.com
Research Institution:
Stub




Abstract
DESCRIPTION (provided by applicant): The Company's business and research efforts are focused on developing and commercializing a novel drug delivery approach to prevent the abnormal ingrowth of tissue (intimal hyperplasia) that can block the flow of bloodthrough artificial blood vessels (vascular grafts) that are widely used in hemodialysis patients, and to restore blood flow through diseased arteries in the lower limbs. Although synthetic grafts in larger arteries perform well, there remains a compellingneed to improve the performance of smaller diameter grafts that fail primarily as a result of obstructive tissue ingrowth. These grafts typically fail within a few months-to-years after surgical placement. Approximately 3B annually is spent on graft maintenance. The Company has developed a method for infusing drugs directly through the porous wall of clinical vascular grafts, such as expanded polytetrafluoroethylene (ePTFE), so that drug is infused only into the slowest moving blood layers along the graftwall. Consequently, drug is transported distally, localizing at troublesome venous anastomotic sites where abnormal tissue proliferation occurs. This method - based on well-known engineering principles - turns out to be extremely efficient for localizing drug delivery. Proof-of- concept with this approach has recently been confirmed in non-human primate studies, completed at the Oregon National Primate Research Center, showing that very low doses of sirolimus, locally infused through ePTFE grafts, can effectively and safely abolish the tissue ingrowth that would otherwise lead to graft obstruction. The goals of this Phase I SBIR application are to develop a FDA acceptable injectable sirolimus formulation that is: 1) soluble and stable for at least 30 days atbody temperature 2) biocompatible with a commercially available low flow, refillable internal pump, tubing and graft cuff, and 3) that demonstrates the appropriate pharmacokinetic profile to provide sirolimus at effective local drug concentrations to suppress ePTFE graft failure without eliciting systemic immunosuppression. PUBLIC HEALTH RELEVANCE: The goals of this grant application are to develop a FDA acceptable injectable sirolimus formulation that is: 1) soluble and stable for at least 30 daysat body temperature 2) biocompatible with a commercially available low flow, refillable internal pump, tubing and graft cuff, and 3) that demonstrates the appropriate pharmacokinetic profile to provide sirolimus at effective local drug concentrations to suppress ePTFE graft failure without eliciting systemic immunosuppression.

* information listed above is at the time of submission.

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