Company: SHPH
Filing Date: 2025-02-13
Form Type: S-1
Source: 0001493152-25-006202
Chunk: 73

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-13
Form: S-1
Chunk 73
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 seven courses of treatment with Ropidoxuridine.      |

| ● | The                                          
 Phase II clinical study is summarized below: |

| 46 |

Schema for the Phase II clinical trial. The initial cohort of 40 patients will be randomized to one of two Ropidoxuridine doses. 20 patients will receive the 1200 mg dose and 20 patients will receive the 960 mg dose. The optimum dose will be determined by comparing drug bioavailability and side-effects. The optimum dose will then continue to enroll 14 additional patients to provide the required 34 patients for statistical significance in comparison to historical controls.

| ● | Ropidoxuridine                                                                                                                            
 and Tipiracil (IPdR/TPI) is a new combination formulation demonstrating extended bioavailability after oral administration                
 in an animal model system. The IPdR/TPI formulation will undergo preclinical development for use as a radiation sensitizer and represents 
 a “next generation” drug product for clinical evaluation.                                                                                 |
| ● | SP-2-225                                                                                                                                  
 is Shuttle Pharma’s pre-clinical class IIb selective HDAC inhibitor that affects histone deacetylase HDAC6 has been                       
 identified as the candidate lead molecule for development as a post-RT innate immune system activator. The macrophage is a key target     
 for activating the innate immune system against cancer cells. SP-2-225 has effects on the regulation of the immune system by maintaining  
 macrophage cells in an inflammatory, anti-cancer polarization. The interactions of RT with the immune response for cancer treatment       
 are of great current interest, offering insight into potential mechanisms for primary site and metastatic cancer treatment. For this      
 reason, Shuttle Pharma has selected SP-2-225 as the candidate lead HDAC inhibitor for preclinical development. We have contracted         
 with investigators at Georgetown University to perform preclinical studies of immune activation after radiation therapy in an animal      
 tumor model. These data have been published (Noonepalle SKR, Grindrod S, Aghdam N, Li X, Gracia-Hernandez M, Zevallos-Delgado C,          
 Jung M, Villagra A, Dritschilo A. Radiotherapy-induced Immune Response Enhanced by Selective HDAC6 Inhibition. Mol Cancer Ther. 2023      
 Dec 1;22(12):1376-1389. doi: 10.1158/1535-7163.MCT-23-0215