Company: MDCXW
Filing Date: 2025-05-27
Form Type: S-1
Source: 0001062993-25-010333
Chunk: 112

Company: Medicus Pharma Ltd.
Filing Date: 2025-05-27
Form: S-1
Chunk 112
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 or 60 min (Trial #2), and analyzed for concentrations of doxorubicin and well as visual inspection of D-MNAs post application.                                                                                                                                                                                                                                                              |     | The size and fragility of the rabbits resulted in inconsistent delivery profiles from the D-MNA and the Sponsor deemed the D-MNA unsuitable for use in the rabbit model. |
| Other                                                              
 (Pyrogenicity & Skin Irritation): SRC Study No. S15054             |     | 21-Dec-2017 |     | New Zealand White rabbit 6-7 months old, 3M per group n = 15 |     | 50, 100, 200 µg/dose modified D-MNA gel + buffer, vehicle, LPS positive control (pyrogenicity), SLS positive control (dermal irritation) |     | Days 1 and 8 |     | Day 1: SC injection of gel for pyro.; Day 8: gel for irritation |     | GLP. Day 1 - core body temperatures were measured at baseline and at post modified D-MNA gel administration at 30 min intervals until 4 hours, and then at 8 and 24 hours. Day 8 - Modified Draize scoring at baseline and at 1, 4, 24 and 48 hour post modified D-MNA gel administration. For the reference control (Group 5), animal body temperatures were above normal (104.8-107.7F/40.4-42.1C) for all animals during the first 4 hours after intravenously administered. |     | No noteworthy changes in body temperature or skin irritation for test article. Severe skin irritation was observed on all the test sites (SLS) in group 5.               |

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Murine Local Lymph Node Assay

The purpose of this study (BRT Study No. 20170725) was to evaluate the sensitization potential of doxorubicin, the active component of D-MNA, when applied at 4 concentrations (25, 50, 100, 200 µg) to both mouse ears, once daily for 3 consecutive days, in the LLNA.

There were no clinical observations or signs of erythema in the vehicle group or in test article-treated animals. No meaningful body weight loss was observed in any of the control or treatment groups.

Treatment-group mean ear thickness values did not increase by 25%