# Determining Effectiveness of V-10 Self-Assembling Pro-Angiogenic Peptide in Re-Vascularizing and Accelerating Wound-Healing in a BBZDR Rat Model of Diabetic Foot Ulceration

> **NIH NIH R43** · NANGIOTX, INC. · 2020 · $109,000

## Abstract

Project Summary / Abstract
NangioTx has developed a patented technology for promoting neovascularization in ischemic tissues. Its lead
compound is a 33-amino-acid pro-angiogenic peptide V-10, which, when injected into an ischemic tissue
microenvironment, generates mature microvasculature, aiding tissue regeneration. A proof of concept for such
tissue regeneration has been obtained in a murine hind-limb ischemia model. The FDA has informed us that this
proof of concept is sufficient for NangioTx to test the compound in humans provided that we document that no
toxic or undesirable side effects are associated with our peptide. The company is now conducting formal safety
and toxicity studies to support a future IND application.
We have selected Diabetic Foot Ulcers (DFU) as our initial therapeutic target. DFU is a serious complication in
>23 million diabetics in the U.S., doubling the cost of care per patient. Each diabetic is likely to develop at least
one diabetic ulcer during the course of the disease. Lesions of this type can enlarge quickly, become infected
and require radical clinical intervention including limb amputation. Conventional management of DFU involves
frequent visits to physician offices while the more advanced/expensive treatments are not generally effective,
leaving the patient to endure a chronic health condition. The processes associated with the development of DFU
involve dysfunction in many elements of normal wound healing mechanisms, such as the poor production of
blood-vessel networks needed for wound resolution. We hypothesize that our pro-angiogenic peptide scaffold
will initiate development of new mature blood vessels in the DFU tissue, facilitating wound healing could proceed.
In this SBIR grant application, we aim to determine the efficacy of this material to generate new blood vessels in
a established and validated diabetic rat model of chronic, slow-healing wounds. A total of 40 inbred Bio-Breeding
Zucker diabetic rats will be randomized into five experimental groups each comprised of 8 animals. Wounds will
be treated by the application of V-10 hydrogel or vehicle as follows: Group A will receive a topical application of
25 µL V-10; Group B will be treated with an equal volume of vehicle; Group C will receive 25 µL of V-10 hydrogel
by intramuscular injection; Group D will receive 50 µL V-10 hydrogel by intramuscular injection; and Group E will
serve as the vehicle control for the injected groups. Tissue samples collected from the animals after 30 days of
treatment will be examined by histopathology for parameters of inflammation, granulation, and re-
epithelialization. Fibrous connective tissue in the granulation bed will be quantified using a computerized image-
analysis system. In parallel, storage stability of V-10 and its formulation will be monitored throughout the duration
of the study using mass spectrometry. Any detected degradation product at level of >1% will be characterized.
Success in this project would i...

## Key facts

- **NIH application ID:** 10018641
- **Project number:** 5R43DK121599-02
- **Recipient organization:** NANGIOTX, INC.
- **Principal Investigator:** Marwa Choudhury
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $109,000
- **Award type:** 5
- **Project period:** 2019-09-15 → 2020-12-19

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10018641

## Citation

> US National Institutes of Health, RePORTER application 10018641, Determining Effectiveness of V-10 Self-Assembling Pro-Angiogenic Peptide in Re-Vascularizing and Accelerating Wound-Healing in a BBZDR Rat Model of Diabetic Foot Ulceration (5R43DK121599-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10018641. Licensed CC0.

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