Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 20

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 20
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 to fund a Phase I clinical trial in collaboration with Brown University
at the Lifespan/Rhode Island Hospital to determine the maximum tolerated dose in patients with advanced gastrointestinal cancers. In
connection with the trial, NCI approved the Phase I clinical protocol and provided drug and clinical data management support to Rhode
Island Hospital. The Phase I clinical trial has been completed and the results support advancing Ropidoxuridine to Phase II clinical
trials of brain tumors, sarcomas and other tumors.

The
following tables provide data from reported clinical trials of Iododeoxyuridine and RT therapy in brain cancers (glioblastoma multiforme)
and high-grade sarcomas. Our primary strategy for Ropidoxuridine and RT therapy is to provide oral drug delivery to effect radiation
sensitization of cancers and validate effectiveness in glioblastoma and sarcoma, potential “Orphan” indications.

15

Brain
Cancer Treatment

Efficacy
compared to historical RT-alone controls for treatment

of
high-grade primary brain tumors (RTOG*, NCI** trials)

    **
    IUdR
    continuous IV infusion (1000 mg/m2/ day/ 14 days), Total of 39 patients (F. Sullivan, et al. Int J Radiat Oncol Biol Phys. 1994;
    30(3):583-90)

    *
    IUdR
    continuous IV infusion (2000 mg/m2/ 4 day infusion/ 6 week treatment), Total of 21 patients (R. Urtasun, et al. Int J Radiat Oncol
    Biol Phys. 1996;36(5):1163-7.)

Sarcoma
Treatment

Efficacy
compared to historical RT-alone controls for treatment

of
high-grade sarcomas (University of Michigan*** trials)

    ***
    16
    patients were treated with continuous infusion (1000-1600 mg/m2/day) plus RT (J.M. Robertson, et al. Int J Radiat Oncol Biol Phys.
    1995; 31(1):87-92).

In
addition to our primary product candidate, we are developing and planning to develop other cancer radiation sensitizers and radiation
protectors, which target protecting normal tissue during the administration of RT, and other products utilizing our HDAC small molecule
technology platform.

SBIR
Contracts

The
SBIR Program