Company: SHPH
Filing Date: 2025-02-13
Form Type: S-1
Source: 0001493152-25-006202
Chunk: 72

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-13
Form: S-1
Chunk 72
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 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,          
 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 Pharma                   
 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 administering the clinical trials and achieved over 38% enrollment in the initial randomized portion of its Phase                     
 II clinical trial (15 patients). Thus far, half the patients enrolled have completed all