Company: SHPH
Filing Date: 2025-01-15
Form Type: S-1
Source: 0001493152-25-002253
Chunk: 9

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-01-15
Form: S-1
Chunk 9
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opidoxuridine 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 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