# A multivalent, easy-to-use product to mitigate and treat radiation exposure

> **NIH NIH R44** · FIBROPLATE, INC. · 2021 · $877,876

## Abstract

ABSTRACT
The threat of radiological and nuclear accidents or attacks demands effective radiation medical countermeasures
(MCM) able to mitigate and treat the effects of exposure to ionizing radiations. Hematopoietic acute radiation
syndrome (HRAS) and cutaneous radiation syndrome (CRS) pose severe, life-threatening risks to exposed
individuals. Currently no effective radio-mitigator (to be administered after radiation exposure but prior to tissue
toxicity manifestation) or radio-therapeutic (to be administered after tissue toxicity manifestation) has yet
received FDA approval. Fibroplate, Inc. developed Fibrinoplate-S (FPS), an intravenous injectable solution of
Fibrinogen-coated Albumin nano-Spheres originally developed to augment hemostatic functions in multiple
clinical settings. Preliminary studies conducted on irradiated rodents suggested that FAS administered after
ionizing radiation exposure has a unique potential as a multi-valent MCM against radiations. In particular, it was
demonstrated that FPS has prophylactic properties against Radiation-induced Skin Injuries (RSI). During the
SBIR Phase I project, a preclinical feasibility study in rats was performed to demonstrate FPS’ efficacy as a
therapeutic treatment for RSI. Several objectives were accomplished: 1) The efficacy of FPS as both prophylactic
and therapeutic treatment for RSI was demonstrated. 2) An FPS-induced stem cells mobilization towards the
lesion was observed. 3) The efficacy of FPS as a mitigator for neutropenia and thrombocytopenia was confirmed.
4) A regulatory effect of FPS on the cytokine profile was discovered. Results obtained in Phase I represent the
perfect starting point for this SBIR Phase II project, where additional preclinical studies will be performed and
used to complete an IND submission package to the FDA, to pursue FDA approval according to the Animal
Efficacy Rule. In this SBIR Phase II project, Fibroplate aims at: i) Demonstrate FPS efficacy as a therapeutic
treatment for RSI in minipigs, as a second animal model. ii) Assess FPS toxicology profile in rats, iii) Assess FPS
stability and shelf-life, iv) Scale-up current manufacturing process to reach production volumes sufficient to
sustain the clinical development. Obtaining FDA approval for FPS will pave the way for its inclusion in the
Strategic National Stockpile as MCM for radiological/nuclear emergencies.
1

## Key facts

- **NIH application ID:** 10160769
- **Project number:** 5R44AI142964-03
- **Recipient organization:** FIBROPLATE, INC.
- **Principal Investigator:** Richard Yen
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $877,876
- **Award type:** 5
- **Project period:** 2019-01-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10160769

## Citation

> US National Institutes of Health, RePORTER application 10160769, A multivalent, easy-to-use product to mitigate and treat radiation exposure (5R44AI142964-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10160769. Licensed CC0.

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