Company: SHPH
Filing Date: 2025-01-24
Form Type: 424B3
Source: 0001493152-25-003508
Chunk: 7

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-01-24
Form: 424B3
Chunk 7
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.” In December 2023, we submitted an IND application with the FDA to support the next phase              
 of development of Ropidoxuridine. In January 2024, we received the ‘Safe to Proceed’ letter from the FDA for our IND                         
 application for the Phase II study of Ropidoxuridine (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 all six of the planned research centers which have begun performing our Phase                                      
 II clinical trial. Ten patients have enrolled in the study as of January 10, 2025 and half of those patients have already completed          
 all seven courses of treatment with Ropidoxuridine.                                                                                          |

| 3 |

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

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 bio