Company: MDCXW
Filing Date: 2025-05-27
Form Type: S-1
Source: 0001062993-25-010333
Chunk: 111

Company: Medicus Pharma Ltd.
Filing Date: 2025-05-27
Form: S-1
Chunk 111
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-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.

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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-MNAs post application. 3-month old minipigs were ultimately used due to ease of handling and blood draws. |     | D-MNA                                                                                                                                                                       
 administration was acceptable. 3- month old minipigs chosen for technical reasons. And 60 minutes resulted in backing part of array being too soft.                         |
| Repeat-Dose: SRC Study No. S15055       |     | 05-Feb-2018 |     | Yucatan Minipig                           
 3-month old; 3M/3F                        
 per group                                 
 n = 30                                    |     | 0, 25, 50 and 200 µg/dose D- MNA; 2 mg/kg IV doxor