Alternate Delivery of Potent Antiangiogenic Agent-AdPEDF

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$139,924.00
Award Year:
2004
Program:
SBIR
Phase:
Phase I
Contract:
1R43EY015594-01
Award Id:
70811
Agency Tracking Number:
EY015594
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
GENVEC, INC., 65 W WATKINS MILL RD, GAITHERSBURG, MD, 20878
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
LISA WEI
(240) 632-5539
LWEI@GENVEC.COM
Business Contact:
C KING
(240) 632-5537
RKING@GENVEC.COM
Research Institute:
n/a
Abstract
DESCRIPTION (provided by applicant) Exudative age-related macular degeneration (AMD) and proliferative diabetic retinopathy (DR), due to aberrant choroidal and retinal neovascularization respectively, are two of the leading major causes of blindness in the US. PEDF (Pigment Epithelium-Derived Factor) is a potent endogenous antiangiogenic/neurotrophic factor and is purported to be the key natural regulator of vascularity in the eye. In experimental disease models, PEDF blocks choroidal and retinal neovascularization. Based on these compelling data, we hypothesize that periocular administration of PEDF using a gene-expressed production system (AdPEDF.11) may treat blinding ocular neovascular diseases such as wet AMD. Pedocular administration, to the space outside the sclera of the eye, is a well-established low risk procedure. Delivery to the periocular space avoids the potential morbidity of intraocular administration. In this Phase I application, we will test the feasibility of periocular administration in preclinical studies. We propose: 1) To determine PEDF expression levels in the eye after periocular delivery and compare the results to that found with intraocular delivery; 2) To determine if repeat periocular administration will result in elevated PEDF levels and 3) To evaluate whether PEDF will be expressed in animals that have high circulating neutralizing antibodies to adenovectors following a periocular administration of AdPEDF.11. Based on the data generated in the Phase I study, we will determine the scientific and commercial feasibility of using periocular administration as a means to deliver PEDF to patients with wet AMD. Successful completion of the above objectives will then provide the basis for future PEDF clinical studies using periocular administration. The goal of the SBIR Phase II grant will be to optimize further the periocular delivery method of AdPEDF.11 in preparation for clinical testing. Periocular delivery could provide a feasible and safer method of delivery of agents to the eye for wet AMD and other ocular diseases than intraocular methods.

* information listed above is at the time of submission.

Agency Micro-sites


SBA logo

Department of Agriculture logo

Department of Commerce logo

Department of Defense logo

Department of Education logo

Department of Energy logo

Department of Health and Human Services logo

Department of Homeland Security logo

Department of Transportation logo

Enviromental Protection Agency logo

National Aeronautics and Space Administration logo

National Science Foundation logo
US Flag An Official Website of the United States Government