# Fibrinogen-coated albumin nanospheres for mitigation of irradiation-induced wound healing impairment in breast cancer patients.

> **NIH NIH R43** · FIBROPLATE, INC. · 2024 · $386,470

## Abstract

PROJECT SUMMARY
Impaired wound healing after radiation therapy is a major clinical challenge in the management of oncologic
patients. The efficacy of radiotherapy in cancer treatment is often accompanied by the disruption of biological
pathways underlying the wound repair process, with considerable side effects represented by skin injuries and
ulcers. At the same time, the need for complete wound healing after a surgical procedure could delay the
administration of radiotherapy, essential for cancer remission, posing a potential threat to patients’ survival.
Current clinical practice is limited to conservative management of irradiated wounds, without targeting the
pathogenesis of impaired wound healing after radiation. Fibroplate has conceived Fibrinoplate-S (FPS), a
solution based on intravenously injectable Fibrinogen-coated Albumin nano Spheres (FAS) with a unique
multivalent potential to accelerate chronic wound healing in multiple soft tissues. Previous studies showed that
FPS can accelerate the healing of Radiation Skin injuries by promoting mobilization of progenitor cells of various
lineages including Endothelial Progenitor Cells (EPCs), and by regulating the levels of several cytokines involved
in inflammatory states. By taking advantage of this knowledge, Fibroplate Inc. proposes to perform the first
preclinical assessment of FPS efficacy to accelerate the healing of the surgical wound in oncologic patients
undergoing radiotherapy. If confirmed, FPS could shorten the time window between surgery and RT by improving
surgical wound healing with a positive impact on cancer treatment. In this SBIR Phase I project Fibroplate aims
to achieve two objectives. 1) Demonstrate the ability of FPS to promote surgical wound healing after
radiotherapy. A murine orthotopic metastatic breast cancer model will be used to mimic human breast cancer
progression and treatment including mastectomy procedures. Wound closure and strength, cytokine panel, and
degree of neovascularization will be assessed. The same model will also serve as validation of FPS’ mode of
action. In particular, Fibroplate will validate the ability of FPS to induce mobilization of progenitor cells, which will
confirm that the mode of action of FPS is not affected by the cancer environment. 2) Assess FPS’ safety profile
on mice with a preliminary evaluation of its impact on coagulation parameters, and evaluation of health
parameters including body weight and residual tumor mass (if any). This work will be preparatory of a Phase II
project, where Fibroplate aims to perform additional IND-enabling studies to further characterize FPS’ dosing,
efficacy, and safety profile in mice and minipigs cancer models.

## Key facts

- **NIH application ID:** 11062568
- **Project number:** 1R43CA291219-01A1
- **Recipient organization:** FIBROPLATE, INC.
- **Principal Investigator:** Richard Yen
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $386,470
- **Award type:** 1
- **Project period:** 2024-09-12 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11062568

## Citation

> US National Institutes of Health, RePORTER application 11062568, Fibrinogen-coated albumin nanospheres for mitigation of irradiation-induced wound healing impairment in breast cancer patients. (1R43CA291219-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/11062568. Licensed CC0.

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