Company: MDCXW
Filing Date: 2025-03-28
Form Type: 253G2
Source: 0001062993-25-006502
Chunk: 26

Company: Medicus Pharma Ltd.
Filing Date: 2025-03-28
Form: 253G2
Chunk 26
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 for three doses total were well tolerated. Tissue reactions were limited to inflammatory reactions of the dermis at the treated sites. |

26

| Study                                                                                                                                                            |     | Start       
 Date        |     | Model                                         |     | Dose                                               |     | Frequency/ 
 Duration   |     | Route of                
 Admin                   |     | Observations                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |     | Conclusions                                                                                                                                                  |
| Local                                                                                                                                                            
 Tolerance: SRC                                                                                                                                                   
 Study No. S15055 (continued)                                                                                                                                     |     |             |     |                                               |     |                                                    |     |            |     |                         |     | Group 5 (reference control IV doxorubicin) males and females both had numerically or significantly decreased WBC, red blood cell counts, hemoglobin, hematocrit, platelets (females only), neutrophils, lymphocytes, monocytes (females only), eosinophils and reticulocytes. Group 5 (reference control) males had significantly (p<0.05) elevated APTTD and fibrinogen on study Day16. Blood samples (plasma) analyses after array administration on dosing phase Day 1 and 14 showed that there was no detectable doxorubicin systemic exposure after topical application at doses up to 200 μg via D-MNA (lower limit of detection was 0.250 ng/mL). For the reference control animals, all animals had detectable concentrations of doxorubicin for up to 8 hours post dose administration. |     | D-MNA doses of                                                                                                                                               
 up to 200 µg per week for three doses total were well tolerated. Tissue reactions were limited to inflammatory reactions of the dermis at the treated sites. |
| Immunotoxi-cology (LLNA Pilot): BRT Study 20170724                                                                                                               |     | 21-Feb-2018 |     | CBA/J Mice 8- weeks old; 2F per group N =8    |     | 25, 50, 100, 200 µg/ear modified D- MNA gel + DMSO |     | Days 1-3   |     | Topical gel (both ears) |     | Modified D-MNA gel + DMSO was applied for three days and ear thickness and irritation were determined.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |     | None had ≥ 25% increase of ear thickness or skin irritation.                                                                                                 |
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