MEDIBEACON INC. — Department of Health and Human Services SBIR Phase I: N

Description

PROJECT SUMMARY ABSTRACT Fluorescent angiography is a commonly used diagnostic tool for visualizing eye vasculature when a physician suspects a patient suffers from retinal vascular diseases such as diabetic retinopathy and age related macular degeneration To visualize eye vasculature the fluorescent dye fluorescein is injected intravenously Administration of fluorescein is associated with both mild and severe adverse reactions Mild reactions such as nausea vomiting and pain at the injection site are frequent and likely associated with the need to dissolve fluorescein in alkaline solutions More severe reactions such as allergic reactions seizures and death are less frequent but limit ocular angiography use since a crash cart must be present during fluorescein administration MediBeacon has developed a second generation IV fluorescent dye MB with several advantages over fluorescein MB is soluble at physiological pH and therefore does not require alkaline dissolution Also there is no known metabolism of MB in humans suggesting that the likelihood of an anaphylactic response will be considerably lower than for fluorescein We have preliminary proof of concept data from mice showing that MB can be used to visualize ocular vasculature MB has undergone full preclinical toxicology and was found safe in a subject Phase I human study for another indication This SBIR will assess the use of MB for visualizing ocular vasculature in healthy dogs and dogs with either hypertensive or diabetic retinopathy The first specific aim of this project is to establish a standardized protocol for MB administration and compare the quality of images obtained with MB to images obtained using standard fluorescein angiography As part of this aim we will first optimize the imaging setup for detection of MB and then establish the optimal MB dose for performing anterior and posterior segment angiography in healthy dogs The second specific aim of this project tests MB in dogs suffering from hypertensive or diabetic retinopathy This aim is to compare and contrast the diagnostic capabilities of MB to standard fluorescein imaging The goal of this project is to prove that MB can provide the same diagnostic information as fluorescein in eye vasculature diseases According to our internal analysis fluorescein is a $ million annual market served by a number of generic pharmaceutical companies A superior proprietary reagent with an improved safety profile and better diagnostic utility should lead to significant market adoption PROJECT NARRATIVE MediBeacon has developed a novel safe and highly fluorescent IV dye for use in humans This project will develop this dye to visualize ocular vasculature MB will alleviate pain and suffering associated with the current fluorescent dye used for ocular angiography and enable expanded use of ocular angiography in human disease diagnostics