# 38 Day Toxicity Study of Subcutaneous Asparaginase in Beagle Dogs

> **NIH FDA R01** · ASSISI RESEARCH LABORATORIES, LLC · 2022 · $250,000

## Abstract

February 2022
Project Summary/Abstract
Asparaginase is MUMS Designated for the induction of remission in multicentric lymphoma in
dogs. To date, toxicity data regarding the use of asparaginase in dogs has not been available. As
part of the approval process for asparaginase as a new animal drug, a Target Animal Safety Study
has been proposed to, and concurred with by, the Center for Veterinary Medicine of the Food and
Drug Administration. The study involves the subcutaneous administration of asparaginase to
thirty-two (16/sex) dogs, randomly assigned to 4 groups of 4/sex/group to determine the toxicity
of asparaginase when given once weekly for 6 doses (Days 1, 8, 15, 22, 29 and 36) ranging from
0 IU/kg/dose (control animals), to 400, 800, or 1600 IU/kg/dose. Animals will be terminated and
necropsied on Day 38. Local and systemic effects of asparaginase administration will be
catalogued both in-life and at necropsy. In addition, because asparaginase is a heterologous protein
(it is derived from E. coli), study animals will be observed each day of the study for signs of
hypersensitivity reactions and blood samples will be collected throughout the study period from
all study animals for subsequent determination of the presence of anti-drug antibodies if
hypersensitivity reactions are detected by in-life observations or at necropsy. Ultimately, the data
collected by this study will be presented, in summary fashion, in the Animal Safety portion of the
approved product prescribing information for the benefit of prescribing veterinarians.

## Key facts

- **NIH application ID:** 10563091
- **Project number:** 1R01FD007591-01
- **Recipient organization:** ASSISI RESEARCH LABORATORIES, LLC
- **Principal Investigator:** Charles Ralph Krikorian
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $250,000
- **Award type:** 1
- **Project period:** 2022-07-01 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10563091

## Citation

> US National Institutes of Health, RePORTER application 10563091, 38 Day Toxicity Study of Subcutaneous Asparaginase in Beagle Dogs (1R01FD007591-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10563091. Licensed CC0.

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