Company remains on track to initiate the
clinical trial in Q4 of 2023
ROCKVILLE, Md., Sept. 25,
2023 /PRNewswire/ -- Shuttle Pharmaceuticals
Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage
specialty pharmaceutical company focused on improving the outcomes
of cancer patients treated with radiation therapy (RT), today
announced receipt of written responses to questions submitted for a
Type B pre-Investigational New Drug Application (PIND) meeting with
the U.S. Food and Drug Administration (FDA). The FDA's positive
feedback and guidance on the Company's Chemistry, Manufacturing,
and Controls (CMC) and clinical protocol design for Ropidoxuridine
provides a pathway to IND application submission in the fourth
quarter of 2023 to initiate the Phase 2 clinical trial.
"The FDA's written responses provide clarification and guidance
on key aspects to our Phase 2 clinical design and CMC protocols,
paving the way to Shuttle's clinical development of Ropidoxuridine
as a radiation sensitizer for treating glioblastoma," commented
Shuttle Pharma's Chairman and CEO, Anatoly
Dritschilo, M.D.
Ropidoxuridine (IPdR) is Shuttle's lead candidate radiation
sensitizer for use in combination with RT to treat brain tumors
(glioblastoma), a deadly malignancy of the brain with no known
cure. Shuttle 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,
its Quarterly Reports on Form 10-Q for the periods ended
March 31, 2023 and June 30, 2023, filed with the SEC on May 25, 2023 and August
14, 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.