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Development of a Topical siRNA Therapy to Promote Burn Wound Healing via Depletion of the Novel Microtubule Regulatory Fidgetin Like

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AR070696-01A1
Agency Tracking Number: R43AR070696
Amount: $224,913.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAMS
Solicitation Number: PA16-302
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-01
Award End Date (Contract End Date): 2018-02-28
Small Business Information
105 SYLVAR ST
Santa Cruz, CA 95060-3728
United States
DUNS: 079613572
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 BRIAN OROURKE
 (718) 430-3464
 adam@microcures.com
Business Contact
 BRIAN O'ROURKE
Phone: (718) 430-3464
Email: david@microcures.com
Research Institution
N/A
Abstract

There are clinically treated burn wounds in the United States each year The recovery
from these burn wounds involves prolonged healing that can take up to a year or more before
there is complete tissue regeneration In many cases the burn victim is left with disfiguring scars
Wound healing occurs in three distinct stages an initial inflammatory phase Phase a
proliferative phase Phase and a long tissue remodeling phase Phase that restores the
skin to the pre wound state As strategies for wound care have evolved from skin grafts and
passive dressings to biopharmaceutical approaches most innovation has continued to promote
only Phase either with new materials that better clean and protect the wounded tissue or with
growth factors and or other factors that modulate the immune response These approaches are
important for coaxing a wound to enter Phase but do little to for remodeling and repair of the
tissue Phase Additionally excessive use of growth factor containing products has been
found to increase lifetime cancer risk in patients Thus to improve patient outcomes there is a
need for a safe and effective therapy that expedites both early stages of wound healing Phases
and and results in a more efficiently closed and effectively matured wound Phase
Fidgetin like FL is a recently discovered regulator of the microtubule cytoskeleton that severs
and depolymerizes microtubules Down regulation of FL expression enhanced microtubule
function to promote cell motility in vitro and improved healing both clinically and histologically in
murine animal models MicroCures aims to develop a topical nanoparticle siRNA treatment
to this novel target FL FL NP si to directly enhance the wound closure and dermal
maturation function of fibroblasts and keratinocytes thereby addressing for the first time
the challenge of accelerated healing and tissue repair in acute wounds Thus wound
healing can occur more rapidly with high fidelity resulting in reduction in endured pain lower risk
of infection shorter hospital stays and decreased scarring
The goal for this proposed project is to characterize a standard formulation of FL NP si in terms
of efficacy and safety in two animal models Yorkshire pig Specific Aim and Sprague Dawley
rat Specific Aim in preparation for IND enabling studies Time to wound healing and
histopathology at the wound site will be evaluated in both animal models In addition whole
animal histopathology and the maximum tolerated dose will be determined in Specific Aim At
the end of the project period we will show that FL NP si is both safe and efficacious for the
treatment of burn wounds and is ready for IND enabling studies There are approximately clinically treated burn wounds in the United States each year
which can take up to a year or more before complete tissue repair Wound healing occurs in three
distinct stages an initial inflammatory phase Phase a proliferative phase Phase and a
long tissue remodeling phase Phase that restores the skin to the pre wound state however
most treatments only affect Phase or more recently Phase MicroCures Inc aims to develop
a topical nanoparticle siRNA treatment directed to a novel target FL FL NP si to directly
enhance the wound closure Phase and and dermal maturation Phase function of
fibroblasts and keratinocytes thereby addressing for the first time the challenge of accelerated
healing and tissue repair in acute wounds

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

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