Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 4

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 4
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oxuridine (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. The Company 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 clinical trials which have begun performing our Phase II clinical trial. Seventeen patients
    have enrolled in the study as of February 24, 2025 and half of those patients have already completed all seven courses of treatment
    with Ropidoxuridine.

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    The
    Phase II clinical study is summarized below:

6

The above chart represents the schema
for the Phase II clinical trial. The initial cohort of 40 patients will be randomized to one of two Ropidoxuridine doses. Twenty 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.

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    Rop