Company: SHPH
Filing Date: 2025-03-13
Form Type: 424B3
Source: 0001493152-25-010109
Chunk: 8

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-03-13
Form: 424B3
Chunk 8
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 and, as a result, were not evaluable. These Phase I trial results    
 demonstrate oral bioavailability and an MTD of 1,200 mg per day for 28 days for use in combination with radiation for Phase II clinical   
 trials that we propose to perform in brain tumors and in sarcomas. The brain tumor, glioblastoma multiforme (GB) is eligible for          
 “orphan” disease designations. Shuttle Pharma has advanced drug manufacture and formulation and prepared a clinical                       
 protocol of a “Phase 2 Single-Arm Study of IPdR as a Radiation Sensitizing Agent During Radiotherapy in Patients with Newly               
 Diagnosed IDH-Wildtype MGMT Unmethylated Glioblastoma Multiforme.” 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, 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 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