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Animal Experimentation

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Service Description

Hokkaido System Science Co., Ltd. (HSS) has entered into a service agreement with Transgenic Inc. (TG) to provide customized animal study services for the research and development of oligonucleotide therapeutics.

Through this service, we propose appropriate in vitro, in vivo, and non-clinical studies tailored to each stage and objective of development, ranging from early drug discovery research to non-clinical development in preparation for IND submission and NDA filing. In addition, with exploratory clinical studies (including investigator-initiated trials) in mind, we also support studies aimed at obtaining robust supporting data.

Service Details

Below, we present representative studies aligned with each stage and objective of development.

1. Drug Discovery Stage

List of Test Items
List of Quality Tests
No  Test Name Example
1
 In Vitro Pharmacology and Toxicity Studies (Conducted by ACEL) ー
2
 In Vivo Mini-Toxicity Study Short-term repeated-dose study using wild-type or genetically modified mice
3
 Other In Vitro Studies Studies using human blood to evaluate oligonucleotide-specific adverse effects

 

2. Non-Clinical Development – Stage 1 (Preliminary GLP Phase)

List of Test Items
List of Quality Tests
No Test Name Example
1
 Dose Range-Finding (DRF) Study in Rodents 2-week intermittent dosing study using genetically modified mice
2
 Dose Range-Finding (DRF) Study in Non-Rodents 2-week intermittent dosing study in dogs

 

3. Non-Clinical Development – Stage 2 (IND-Enabling GLP Studies)

List of Test Items
List of Quality Tests
No Test Name Example
1
 Repeated-Dose Toxicity Study in Rodents 4-week intermittent dosing study using genetically modified mice
2
 Repeated-Dose Toxicity Study in Non-Rodents 4-week intermittent dosing study in dogs

 

4. Non-Clinical GLP Studies Supporting Phase 2 Proof of Concept (POC)

List of Test Items
List of Quality Tests
No Test Name Example
1
 Repeated-Dose Toxicity Study in Rodents 3-month intermittent dosing study using genetically modified mice
2
 Repeated-Dose Toxicity Study in Non-Rodents 3-month intermittent dosing study in dogs
3
 Teratogenicity Study in Rodents and Rabbits –
4
 ADME Study in Rodents Absorption, distribution, metabolism, and excretion study

 

5. Non-Clinical GLP Studies Supporting NDA Submission

List of Test Items
List of Quality Tests
No Test Name Example
1
 Chronic Repeated-Dose Toxicity Study in Rodents 6-month intermittent dosing study using genetically modified mice
2
 Chronic Repeated-Dose Toxicity Study in Non-Rodents 9-month intermittent dosing study in dogs
3
 Developmental and Reproductive Toxicity (DART) Study in Rodents Fertility and early embryonic development study; peri- and postnatal development study
4
 Carcinogenicity Study 6-month carcinogenicity study using genetically modified (rasH2) mice

 

6. Non-Clinical Studies Supporting Exploratory Clinical Trials (Including Investigator-Initiated Trials)

In addition to studies listed in sections 1–5, we propose non-clinical studies designed to support exploratory clinical trials.

List of Quality Tests
Example
Extended Single-Dose Study Using Genetically Modified Mice
7-Day Repeated-Dose Study Using Genetically Modified Mice

 

Studies Using Genetically Modified Mice

For mouse studies listed in sections 2–6, we recommend the use of genetically modified mice to enable clearer evaluation of on-target toxicity. In addition, Transgenic Inc. (TG) is capable of generating and expanding a wide range of transgenic mouse models.

Click here for details (TG website)

How to Request Our Services

STEP 1

Consultation
Please feel free to contact us via the inquiry form regarding our services.
e.g. in vitro studies / in vivo studies / non-clinical studies / generation of genetically modified mice, etc.

※ Free-of-charge web consultation is available on request.

STEP 2

Quotation
We will propose an appropriate test plan and quotation based on your inquiry.

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