# Clinical Translation of Near Infrared Nerve-Specific Fluorophores for Nerve-sparing Prostatectomy

> **NIH NIH R44** · TRACE BIOSCIENCES INC · 2024 · $810,809

## Abstract

PROJECT SUMMARY
 Iatrogenic nerve injury is one of the most feared complications of surgery. Nerves are critically important
to the function of most tissues and nerve injury can lead to permanent disability. Surgery is performed commonly
in the U.S. with approximately 40 million operations annually, incurring up to 600,000 iatrogenic nerve injuries.
One procedure particularly plagued by nerve damage is radical prostatectomy (RP), where nerve damage occurs
in up to 60% of patients, despite the practice of nerve sparing surgical methods for >30 years. At present there
is no clinically approved technology to improve visual recognition of nerve tissue during surgery, leaving
surgeons to rely largely on anatomical knowledge to locate small or buried nerves invisible to the naked eye.
Fluorescence-guided surgery (FGS) is a nascent field with demonstrated efficacy in improving surgical outcomes
for cancer resection and normal anatomy preservation using molecularly-targeted fluorophores and commercial
FGS imaging systems. We have developed several first-in-kind, targeted, near-infrared (NIR) fluorophores that
label nerve tissue with high affinity—to date the most promising is IT01-08. IT01-08 specifically labels rodent,
swine and canine nerves following systemic administration and demonstrates cross reactivity in ex vivo human
specimen staining. Notably, we have developed a library of IT01-08 derivatives, several of which have displayed
vastly improved water solubilities and toxicity profiles in preliminary testing, increasing the no observed adverse
effect level (NOAEL) doses 2-10X. Final solubility, toxicology, and pharmacology testing is required to select a
lead compound from IT01-08 and its derivatives. Following lead compound selection, clinical translation of the
optimal NIR nerve-specific fluorophore will enhance nerve identification during nerve-sparing RP, resulting in
reduced nerve injury and improved patient outcomes. This study’s immediate milestones include – Phase I: (1)
selection of a clinically viable, NIR nerve-specific fluorophore for translation, (2) relevant pharmacokinetics, dose
ranging pharmacodynamics, and biodistribution quantification, and (3) preliminary toxicology analysis to guide
investigational new drug (IND)-enabling studies. Phase II: (4) good laboratory practice (GLP) synthesized
fluorophore and formulation product for, (5) a GLP two-species pharmacology and toxicology (pharm/tox) study
facilitating, (6) a successful IND application to the FDA. Our long-term strategic plan is to develop our NIR nerve-
specific fluorophores for human use to enhance the identification and preservation of nerves with broad clinical
impact for all surgical subspecialties. Completion of the proposed aims will establish pre-clinical testing of these
promising nerve highlighting agents towards first-in-human trials and provide a strong foundation for industry
partnerships and investment for clinical translation.

## Key facts

- **NIH application ID:** 10651903
- **Project number:** 5R44CA247639-04
- **Recipient organization:** TRACE BIOSCIENCES INC
- **Principal Investigator:** Connor William Barth
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $810,809
- **Award type:** 5
- **Project period:** 2022-07-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10651903

## Citation

> US National Institutes of Health, RePORTER application 10651903, Clinical Translation of Near Infrared Nerve-Specific Fluorophores for Nerve-sparing Prostatectomy (5R44CA247639-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10651903. Licensed CC0.

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