ROCKVILLE, Md., Jan. 8, 2024
/PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq:
SHPH) ("Shuttle Pharma") today announced they have received the
'Safe to Proceed' letter from the U.S. Food and Drug Administration
(FDA) for the Company's investigational new drug (IND) application
for its 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 Shuttle to commence the
Phase II study.
Shuttle Pharma is currently finalizing site enrollment with
'first patient, first dose' expected in the coming months.
Ropidoxuridine is Shuttle Pharma's lead radiation sensitizer
candidate for use in combination with radiation therapy (RT) to
treat glioblastoma, a deadly malignancy of the brain with no known
cure.
"We are excited to have been granted approval to commence
Ropidoxuridine's Phase II clinical trial following the receipt of
the FDA's 'Safe to Proceed' letter," stated Shuttle Pharma's
Chairman and CEO, Anatoly
Dritschilo, M.D. "Radiation therapy is a proven modality for
treating cancers. However, there is a significant need in the
market to make radiation more effective. The results of this Phase
II clinical trial will be important as we look to leverage
radiation sensitizers to increase cancer cure rates, prolong
patient survival and improve quality of life for patients suffering
from glioblastoma."
An estimated 800,000 patients in the US are treated with
radiation therapy for their cancers yearly. According to the
American Cancer Society and the American Society of Radiation
Oncologists, about 50% are treated for curative purposes and the
balance for therapeutic care. The market opportunity for radiation
sensitizers lies with the 400,000 patients treated for curative
purposes, with this number expected to grow by more than 22% over
the next five years.
Shuttle Pharma has received Orphan Drug Designation from the
FDA, providing potential marketing exclusivity upon first FDA
approval for the disease.
About Shuttle Pharmaceuticals
Founded in 2012 by faculty members of the Georgetown
University Medical Center, Shuttle Pharmaceuticals is a
discovery and development stage specialty pharmaceutical company
focused on improving the outcomes for cancer patients treated with
radiation therapy (RT). Our mission is to improve the lives of
cancer patients by developing therapies that are designed to
maximize the effectiveness of RT while limiting the side effects of
radiation in cancer treatment. Although RT is a proven modality for
treating cancers, by developing radiation sensitizers, we aim to
increase cancer cure rates, prolong patient survival and improve
quality of life when used as a primary treatment or in combination
with surgery, chemotherapy and immunotherapy. For more information,
please visit our website at www.shuttlepharma.com.
Safe Harbor Statement
Statements in this press release about future expectations,
plans and prospects, as well as any other statements regarding
matters that are not historical facts, may constitute
"forward-looking statements." These statements include, but are not
limited to, statements concerning the development of our company.
The words "anticipate," "believe," "continue," "could," "estimate,"
"expect," "intend," "may," "plan," "potential," "predict,"
"project," "should," "target," "will," "would" and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including factors discussed in the "Risk
Factors" section of Shuttle Pharma's Annual Report on Form 10-K for
the year ended December 31, 2022,
filed with the SEC on March 15, 2023,
and its Quarterly Reports on Form 10-Q for the quarters ended
March 31, 2023, June 30, 2023 and September 30, 2023, filed with the SEC on
May 25, 2023, August 14, 2023 and November 13, 2023, respectively, as well other
SEC filings. Any forward-looking statements contained in this press
release speak only as of the date hereof and, except as required by
federal securities laws, Shuttle Pharmaceuticals specifically
disclaims any obligation to update any forward-looking statement,
whether as a result of new information, future events or
otherwise.
Shuttle Pharmaceuticals
Anatoly Dritschilo, M.D.,
CEO
240-403-4212
info@shuttlepharma.com
Investor Contacts
Lytham Partners, LLC
Robert Blum
602-889-9700
shph@lythampartners.com
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SOURCE Shuttle Pharmaceuticals Holdings, Inc.