Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 9

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 9
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“chemo-radiation” treatments are established in cancers of the head and neck, esophagus, lung, stomach, breast, brain, pancreas,
rectum and uterine cervix. The ideal radiation sensitizer would reach the tumor in adequate concentrations and act selectively in the
tumor, as compared to surrounding normal tissues. It would have predictable pharmacokinetics for timing with radiation therapy and could
be administered with every radiation treatment approach. The ideal radiation sensitizer would have minimal toxicity or manageable enhancement
of radiation toxicity.

The
U.S. market for radiation sensitizing agents is experiencing dynamic growth through development of new radiation technology, the introduction
of new agents, growth in the number of diagnosed patients in a variety of cancers and changes in treatment patterns. New agents have
been introduced, including bevacizumab (Avastin®, Roche), panitumumab (Vectibix®, Amgen), temozolomide (Temodar®, Merck)
and cetuximab (Erbitux®, Eli Lilly/Imclone), with potential as radiation sensitizing agents (though all but cetuximab are used off
label); and all are recommended by the NCCN® (National Comprehensive Cancer Network) in clinical practice guidelines for use in combination
with established therapies such as FOLFOX (leucovorin, 5-FU, oxaliplatin), CapeOX (capecitabine, oxaliplatin) and FOLFIRI (leucovorin,
5-FU, irinotecan).

The
growth in the number of patients with cancers is being driven by an aging population and improved diagnostic tools. According to the
National Cancer Institute (NCI), more than half (~50 - 60%) of all cancer patients undergo some type of radiotherapy during the course
of their treatment. Confirming the patient estimate from the NCI, the American Society for Therapeutic Radiology and Oncology (ASTRO)
factsheet states approximately 67% of approximately 1.25 million cancer patients are treated with radiation therapy annually, either
one or more times. In addition, in a study published by the Journal of Clinical Oncology in 2016, it is estimated that the number of
cancer patients needing radiation therapy will increase by 22% in the next 10 years. (See “The Future of Radiation Oncology
in the United States From 2010 to 2020: Will