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Enhancing Clinical Therapy for wet Age-related Macular Degeneration (wetAMD)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41EY028839-01
Agency Tracking Number: R41EY028839
Amount: $297,786.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: N
Solicitation Number: PA16-303
Timeline
Solicitation Year: 2016
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-05-01
Award End Date (Contract End Date): 2020-04-30
Small Business Information
3913 TODD LANE, SUITE 310
Austin, TX 78744-1057
United States
DUNS: 830066440
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 JASON COOK
 (865) 742-9127
 jason.cook@nanohybrids.net
Business Contact
 KIMBERLY HOMAN
Phone: (512) 810-0072
Email: kimberly.homan@nanohybrids.net
Research Institution
 MASSACHUSETTS GENERAL HOSPITAL
 
55 FRUIT STREET
BOSTON, MA 02114-2696
United States

 Domestic Nonprofit Research Organization
Abstract

ABSTRACTThe wet form of age related macular degenerationAMDaccounts forof all AMD related blindness
and affectsmillion people withnew cases each year in the USMinimally invasive and selective
drug delivery to the eye still remains an open challengethe current standard of care involves delivery of antivascular endothelial growth factoranti VEGFdrugs via intraocular injectionFor patients refractory to antiVEGF drugsphotodynamic therapyPDTis the standard of careClinical efficacy of PDT depends on
significant accumulation of the photosensitizerPSat the choroid neovasculatureCNVavailability of oxygen
near the PSand effective dosing of the drug light combinationOur new platform for delivery and imaging of
PSentitled the Photodynamic therapy NanoDropletPtNDwill enhance all three of these areasraising PDTandapos s
therapeutic index and enabling PDT to become a frontline clinical wet AMD therapyPtND comprises a core of oxygen rich liquid perfluorocarbonPFCcontaining indocyanine greenICGdye stabilized by a lipid shell which both houses the photosensitizerPSand provides binding sites for
conjugating choroid targeting moietiesFollowing intravitreal injectionPtND will transcytose through the retinal
pigment epitheliumbind with choroid neovesselsand undergo receptor mediated endocytosisInterestinglythe ICG dye is used to trigger a liquid to gas phase change of the PFC which serves two purposesit
delivers PS and additional Oto the cell cytosol andthe vaporization event creates a giant acoustic
transient which can be used in combined photoacoustic and ultrasoundPAUSimaging to visualize the
distribution of drug delivery at the CNVFrom the rich spatial information received by PAUS imaging of the
drug distributionlight intensity and duration dosimetry for the choroid region can be calculatedThis
personalized dosimetry will ensure patients receive the correct dose for their disease burdenThe promise of PDT to provide localized therapy with minimal residual damage or systemic side effects is
remarkableThe proposed PtND platform is poised to enhance delivery of PS to CNVincrease efficacy of PDT
through companion Odeliveryand ultimately deliver a personalized patient specific dose enabled by PAUS
imagingThe overall goal of our project is to demonstrate that PtND can raise the therapeutic index of PDT in
vivoleading to a decrease in required treatments for wet AMDand ultimately replace the need for anti VEGF
drugs which carry a risk of systemic side effectsOverall we are excited to develop this nanoplatform for PDT
that will remove the roadblocks to widespread use of this important clinical treatment NARRATIVEThe wet form of AMD accounts forof all AMD related blindness and affectsmillion people withnew cases each year in the USFor patients refractory to anti angiogenesis drugsphotodynamic
therapyPDTis the standard of careClinical efficacy of PDT depends on significant accumulation of the
photosensitizerPSat the choroid neovasculatureCNVavailability of oxygen near the PSand effective
dosing of the drug light combinationOur new platform for delivery and imaging of PSentitled the
Photodynamic therapy NanoDropletPtNDwill enhance all three of these areasraising PDTandapos s therapeutic
index and enabling PDT to become a frontline clinical wet AMD therapy

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

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