# BCN057 as a mitigator of Radiation Induced Gastrointestinal Syndrome

> **NIH NIH R43** · BCN BIOSCIENCES, LLC · 2020 · $299,668

## Abstract

Project Abstract
Currently, there is a need for drugs that mitigate acute radiation induced gastrointestinal syndrome (RIGS). Risk
of large populations encountering radiation exposure is real and growing due to the proliferation of rogue
nonstate actors, political instability resulting in potential access of nuclear weapons by terrorist, and by natural
disaster as evidenced by the release of radioactive material from the Fukushima nuclear power plant in early
2011. Currently, Neupogen®, Nulasta® (filgrastim) and Leukine™ (sargramostim) are the only FDA approved
agents available and only for the management of Hematopoietic Acute Radiation Syndrome. Due to radio-
sensitivity of intestinal epithelium, RIGS is the major cause of death from acute radiation syndrome at high
radiation doses and no drugs are approved at this time. The current options for mitigating tissue damage
and mortality of a large population after exposure to radiation are currently an un met need with approved
drugs unable to fill the gap. Moreover, high radio-sensitivity of intestinal epithelium increases susceptibility
to radiation induced gastrointestinal syndrome ( RIGS) and induces mortality rapidly
within 3-10 days post radiation, leaving very limited time for therapeutic intervention. We have demonstrated
that treatment with BCN057 at 24hrs post radiation exposure can mitigate RIGS by accelerating intestinal
epithelial repair with the activation of Wnt-β catenin signaling and improves survival following lethal dose of
irradiation. Intestinal epithelial repair process is dependent on induction of proliferation of residual
intestinal stem cells. we hypothesized that BCN057 will have a general applicability to
mitigate RIGS when delivered hours after radiation exposure. In this proposal we will
characterize the most effective dose and schedule for administration of BCN057 to
mitigate RIGS in mice. This will include Identifying the optimal dose and schedule of
BCN057 when given at 24 hr post exposure to mitigate RIGS in adult mice; Identify the
time to dosing beyond 24 hr at which BCN057 can still improve survival; Define the
radiation dose modifying factor for BCN057 treatment and verify biological variability in
radiosensitive and gender context. For Specific Aim 1 we will characterize dose proportionality, dose
regimen and dose response of BCN057 for mitigation of Radiation Induced Gastro Intestinal Syndrome by the
FDA animal rule. In Specific Aim2, we will assess time to dosing at 48 and 72 hours, age differences using
young and old mice, genetic radio sensitive and resistance, a phenomenon highly exhibited in adult humans
using (Balc and C57).
Together these studies will demonstrate the utility of BCN057 as a mitigator of RIGS as well as model
response behavior to advance its use for countermeasures and clinical use.

## Key facts

- **NIH application ID:** 9966896
- **Project number:** 5R43AI145784-02
- **Recipient organization:** BCN BIOSCIENCES, LLC
- **Principal Investigator:** Andrew John Norris
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $299,668
- **Award type:** 5
- **Project period:** 2019-07-01 → 2021-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9966896

## Citation

> US National Institutes of Health, RePORTER application 9966896, BCN057 as a mitigator of Radiation Induced Gastrointestinal Syndrome (5R43AI145784-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9966896. Licensed CC0.

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