Company: MDCXW
Filing Date: 2025-09-19
Form Type: DRS
Source: 0001062993-25-015719
Chunk: 123

Company: Medicus Pharma Ltd.
Filing Date: 2025-09-19
Form: DRS
Chunk 123
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 hydrochloride (Groups 2 - 4), respectively. An intravenous ("IV") doxorubicin group consisting of 3 males and 3 females served as a reference control (Group 5). Dosing occurred on Days 1, 7 and 14 with either control array or test article (Groups 1-4), and Group 5 was dosed IV on these same study days. Each topical treatment was 30 minutes. The experimental design is provided in the table below.

Study Design of Minipig Local Tolerance Study

| Group |     | Treatment         |     | Treatment/Dose |     |                                      |     | Number of Animals |     |   |     | Dose Route/       
 Frequency         |
| Array |     | Dosage (µg/dose)  |     |           Male |     |                               Female |     |                   |     |   |     |                   |
| 1     |     | Blank Control     |     |              1 |     |                                    0 |     |                 3 |     | 3 |     | MNA/Days 1, 7, 14 |
| 2     |     | D-MNA-low         |     |              1 |     |                                   25 |     |                 3 |     | 3 |     |                   |
| 3     |     | D-MNA-mid         |     |              1 |     |                                   50 |     |                 3 |     | 3 |     |                   |
| 4     |     | D-MNA-high        |     |              1 |     |                                  200 |     |                 3 |     | 3 |     |                   |
| 5     |     | Reference Control |     |             NA |     | 2 mg/kg (Doxorubicin Hydrocholoride) |     |                 3 |     | 3 |     | IV/Days, 1, 7, 14 |

Note:

(1)Dosing volume for Group 5 was 1 ml/kg (doxorubicin hydrocholoride 2 mg/ml). NA = Not Applicable IV = Intravenous

Blood collections for toxicokinetic evaluation were conducted on Days 1 and 14 post dose administration (post-30 mins application for Groups 1-4) for all groups.

Excluding the group 5 control group, all array-treated groups showed doxorubicin