Company: MDCXW
Filing Date: 2025-09-11
Form Type: DRS
Source: 0001062993-25-015568
Chunk: 130

Company: Medicus Pharma Ltd.
Filing Date: 2025-09-11
Form: DRS
Chunk 130
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.5 cm, as large or larger than the ears themselves. The study sponsor developed a liquid test article containing all the ingredients of the D-MNA with added DMSO, an approved LLNA solvent which helps the test article to penetrate the skin of the mouse ear. The pilot study demonstrated that this test article was non-irritating, and therefore, should perform a valid assessment of D-MNA's sensitization potential (BRT Study No. 20170724).

For the GLP rabbit study (SRC Study No. S15054), the pilot study demonstrated that the rabbit was not a valid model for testing D-MNA due to the lack of underlying musculoskeletal support which allows for the technician to apply pressure to the D-MNA during administration (SRC Study No. S15198). In addition, the presence of tightly spaced hair follicles appeared to at least partially inhibit penetration of the needles on the D-MNA. Accordingly, the Sponsor determined that a subcutaneous injection of modified D-MNA gel, with extra buffer added to make the D-MNA formulation syringeable, would provide a valid assessment of pyrogenicity. This same formulation was also used to test for skin irritation on abraded skin.

The data in the table below describe the results of studies conducted by SkinJect to elucidate the effects of delivering the gel used to make the array or the array itself to the skin.

Summary of Toxicology Studies (Phase 1 Study)

| Study                                   | Start       
 Date        | Model                                     | Dose                                                                              | Frequency/    
 Duration      | Route of  
 Admin     | Observations                                                                                                                                                                                                                                                                                                                                                                                    | Conclusions                                                                                                                                                                 |
| Single Dose: Pilot study, SRC Study No. 
 S15200                                  | 09-Aug-2017 | Yucatan Minipig 1 and 3- month old; 1M/1F 
 n = 4                                     | 50 µg (3 mo. old) and 200 µg (1 month old) D-MNA                                  | Day 1         | D-MNA     | Trial 1: 30 min 1 male and 1 female 3 month old pig. Trial 2: 60 min 1 male and 1 female 1 month old pig. D-MNA was applied to 1- or 3-month old minipigs, removed after 60 or 30 min, respectively, and analyzed for concentrations of doxorubicin as well as visual inspection of D