Company: SHPH
Filing Date: 2025-01-24
Form Type: 424B3
Source: 0001493152-25-003508
Chunk: 74

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-01-24
Form: 424B3
Chunk 74
---
 (IPdR) as                          
 a radiation sensitizing agent during radiotherapy in patients with newly diagnosed IDH-wildtype glioblastoma with unmethylated MGMT           
 promoter. Receipt of the letter allows us to commence the Phase II study of Ropidoxuridine (IPdR). The clinical development of Ropidoxuridine 
 has shown drug bioavailability and a maximum tolerated dose has been established for use in Phase II clinical trials. TCG GreenChem,          
 Inc. (“TCG GreenChem”), with whom we have contracted for process research, development and cGMP compliant manufacture                         
 of IPdR, has successfully completed the manufacturing campaign for the active pharmaceutical ingredient (API) of Ropidoxuridine for           
 use in the Company’s upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy. Shuttle also worked              
 with University of Iowa Pharmaceuticals to develop the formulation and produce the capsules, which have been shipped to contract              
 research organization (CRO) Theradex Oncology for distribution to clinical trial sites. Both activities have now been completed.              
 In addition, Shuttle received approval from the FDA to begin the clinical trial. The FDA made recommendations that led to an expanded         
 clinical trial to include randomized dose optimization and we agreed with the recommendation. We met with representatives from six            
 candidate clinical sites to review the protocol documents and FDA required IRB approvals have been obtained. With FDA recommended             
 changes incorporated into the revised protocol, the Company has now contractually engaged [three] of the planned six research centers         
 which will be performing clinical trials and has initiated its Phase II clinical study.                                                       |

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

| 52 |

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