ROCKVILLE, Md., Dec. 11,
2023 /PRNewswire/ -- Shuttle Pharmaceuticals
Holdings, Inc. (Nasdaq: SHPH) ("Shuttle Pharma") today announced
submission of an Investigational New Drug (IND) application with
the U.S. Food and Drug Administration (FDA) to support the next
phase of development of Ropidoxuridine. Ropidoxuridine is Shuttle
Pharma's lead radiation sensitizer candidate for use in combination
with radiation therapy (RT) to treat brain tumors (glioblastoma), a
deadly malignancy of the brain with no known cure.
RT is a proven modality for treating cancers. However, there is
a significant need in the market to make radiation more effective.
By developing radiation sensitizers, Shuttle Pharma aims 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.
"Today's announcement is an important milestone for Shuttle
Pharma and the thousands of patients with brain tumors who
currently lack effective therapies," stated Shuttle Pharma's
Chairman and CEO, Anatoly
Dritschilo, M.D. "The IND submission is the culmination of
many years of clinical development by the Shuttle Pharma team, as
well as support from the broader cancer community, including the
National Institutes of Health's National Cancer Institute and Small
Business Innovation Research program, who have provided guidance
and grant funding to bring this potentially important new radiation
sensitizing therapy to market."
An IND submission is a request submitted to the regulatory
authorities seeking permission to test a new drug or therapeutic
substance in humans. The submission includes detailed information
about the drug, its composition, pharmacology, toxicology data from
preclinical studies, proposed clinical trial protocols, and
information on manufacturing and quality control. With the IND
application submission now complete, the FDA is expected to provide
Shuttle Pharma with its decision to proceed with the Phase II trial
within approximately 30 days.
The submission of the IND follows recent receipt of written
responses to questions submitted for a Type B pre-Investigational
New Drug Application (PIND) meeting with the FDA in September 2023. During the PIND meeting, the FDA
provided positive feedback and guidance on the Company's Chemistry,
Manufacturing, and Controls (CMC) and clinical protocol design for
Ropidoxuridine, thus providing the pathway to this IND
submission.
The planned Phase II trial will investigate whether a new
treatment, Ropidoxuridine, taken during radiation treatment, will
be a safe and possibly effective for treatment of patients with
newly diagnosed IDH-wildtype glioblastoma with unmethylated MGMT
promoter.
Dr. Dritschilo added, "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. This IND submission is an important
next step in making this mission a reality."
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.