Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 13

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 13
---
glioblastoma), soft tissue sarcomas, and rectal cancers. Glioblastoma multiforme is a deadly malignancy of the
brain with no known cure. Radiation therapy provides delay of disease progression and is standard of care following surgical resection
or biopsy. Radiation therapy is combined with Temodar, a drug that has shown activity (~ four months survival benefit) in treating brain
tumors. Preliminary data using radiation therapy in combination with IUdR resulted in a delay of disease progression of up to six months.
We propose to test IPdR in combination with radiation therapy in the Phase II clinical trial. Similarly, delay in disease progression
has been observed following treatment of sarcomas by the combination of IUdR and RT. Based on the Phase I data of our clinical trial
we know that therapeutic levels of IUdR are reached by administering the orally available prodrug, IPdR.

10

Clinical
Data

The
Phase I results of the clinical trial supported by an SBIR contract to Shuttle Pharma and a sub-contract to the Brown University Oncology
Group (BrUOG) at the LifeSpan/Rhode Island Hospital were reported by the subcontractor at the 30th EORTC-NCI-AACR Symposium in November
2018 and in the medical journal, Clinical Cancer Research, in 2019. Eighteen patients completed dose escalation to 1800 mg/day for 30
days, establishing the maximum tolerated dose (MTD) of 1,200 mg/day in combination with RT. Therapeutic blood levels of IUdR were achieved.
Four patients were scored as partial responses, nine patients had stable disease and one patient progressed in the target lesions. These
data support advancing IPdR and RT to clinical trials for the FDA to determine efficacy.

Development
Plan

A
key to driving the Ropidoxuridine product forward is the development of a clinical plan with aggressive timelines and support within
the radiation oncology community to participate in clinical trials with the appropriate patients to ensure a comprehensive NDA dossier
for each product. Initially, the plan is focused on the Phase I and Phase II clinical trials. Upon completion of Phase II studies, we
will determine whether to extend the Phase II study to a randomized Phase II, or to perform a randomized Phase III clinical trial. Such
determination will be based on results of the initial clinical trials and the end of a Phase II meeting with the FDA. Shuttle Pharmaceuticals