ROCKVILLE, Md., May 26, 2023
/PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq:
SHPH), a discovery and development stage specialty pharmaceutical
company focused on improving outcomes for cancer patients treated
with radiation therapy (RT), today provided a corporate update in
connection with the filing of its Quarterly Report on Form 10-Q for
the quarter ended March 31, 2023.
Recent Highlights
- Shuttle Pharma continues to execute on the necessary steps to
advance Ropidoxuridine, the Company's lead clinical sensitizer drug
candidate, towards the commencement of its upcoming Phase II
clinical trial in brain cancer patients undergoing radiation
therapy with an expectation of pre-IND application submission to
the FDA by the end of the second quarter of 2023.
- Entered into agreements with TCG GreenChem, Inc. and UI
Pharmaceuticals for drug manufacture and formulation development of
Ropidoxuridine, the Company's lead clinical sensitizer drug
candidate, for use in the Company's upcoming Phase II clinical
trial evaluating Ropidoxuridine in combination with radiation
therapy for the treatment of glioblastoma.
- Engaged Theradex Oncology, a leading clinical research
organization, to help prepare for its upcoming clinical study of
Ropidoxuridine.
- Entered into an agreement to lease new laboratory and office
space, commencing in June 2023, to
assist in furthering the development of the Company's lead drug
candidates and accelerate broader diagnostic capabilities on
predictive biomarkers.
- Entered a research agreement with Georgetown University focused on the evaluation of
the Company's lead HDAC6 inhibitor candidate, SP-2-225, evaluating
the anti-tumor effect of the combination of SP-2-225 and RT in a
syngeneic breast cancer model.
- Shuttle Pharma was awarded U.S. Patent No. 11,654,157, "Methods
And Compositions For Cancer Therapies That Include Delivery Of
Halogenated Thymidines And Thymidine Phosphorylase Inhibitors In
Combination With Radiation," which was issued by the U.S. Patent
and Trademark Office on May 23,
2023.
- Published manuscripts discussing prostate cancer cell lines
derived from African American men for precision medicine and immune
responses taking place in patients after radiation therapy for
cancer.
- Awarded patents in the U.S. and Hong
Kong for its radiation sensitizing HDAC inhibitor technology
platform.
- Appointed Dr. Bette Jacobs to
its Board of Directors as an independent director.
- Rang the Nasdaq opening bell in January
2023.
- Closed on private placement of $4.3
Million of Senior Secured Convertible Note and Warrants to
purchase 1.018 million shares of common stock in exchange for
$4.0 million investment.
- At March 31, 2023, the Company
had a working capital balance of $9
million. The Company anticipates that it has sufficient
capital to fund operations into the first quarter of 2025.
"Shuttle Pharma is advancing our mission to improve the lives of
cancer patients by developing therapies that are designed to
maximize the effectiveness of Radiation Therapy while limiting the
late effects of radiation in cancer treatment," commented Shuttle
Pharma's Chairman and CEO, Anatoly
Dritschilo, M.D. "During the first quarter, we made tangible
progress advancing our pipeline, including Ropidoxuridine, our lead
clinical drug candidate, which sensitizes rapidly growing cancer
cells and, our various selective HDAC (histone deacetylase)
inhibitors – which sensitize cancer cells and stimulate the immune
system. With Ropidoxuridine, we are finalizing details to submit
the final protocol details to the FDA at the end of the second
quarter of 2023 with commencement of the Phase II clinical trial in
brain cancer patients commencing shortly thereafter. Additionally,
we are advancing pre-clinical work to support our IND-enabling
studies in 2023 with a goal to submit an investigational new drug
application (IND) for the selective HDAC6 inhibitor and initiation
of a Phase I clinical trial in 2024. We look forward to an exciting
2023 as we advance our immuno-oncology and radio-oncology
solutions."
Radiation Therapy Sensitizer Platform
Radiation therapy is a proven modality for cancer treatment. By
developing radiation sensitizers, Shuttle Pharma aims to increase
cancer cure rates, prolong patient survival and improve quality of
life when radiation is used as a primary treatment, or in
combination with, surgery, chemotherapy and immunotherapy.
Modern oncology incorporates multi-modality strategies that use
combinations of surgery, chemo or immunotherapy, and radiation to
treat cancers. Radiation therapy requires delivery and shaping of
high doses of radiation energy to tumors to kill or slow the growth
of cancer cells by damaging their cellular DNA. State-of-the-art
technologies to deliver the radiation doses include image guided
treatments with linear accelerators and particle radiation with
protons. However, radiation therapy of adjacent healthy tissues can
lead to injuries of normal organs. The addition of radiation
sensitizers allows preferential increased killing of cancer
cells.
Currently, there is only one drug on the market approved by the
FDA as a radiation sensitizer. However, that drug has a host of
side effects that limit its utility. Other drugs are used "off
label" by radiation oncologists, but these often have additional
side effects. There is an urgent need for an effective radiation
sensitizer with low toxicity for use in combination with radiation
therapy.
Shuttle Pharma's lead candidate, Ropidoxuridine, is an orally
available prodrug, that once ingested, metabolizes into
iododeoxyuridine, a pyrimidine analog, that has been recognized as
a radio sensitizing agent since the 1960s. The Company is advancing
its planned Phase II clinical trial of Ropidoxuridine in brain
cancer patients undergoing radiation therapy for glioblastoma.
Shuttle is currently preparing the Investigational New Drug
application for the study with an expectation of final submission
to the FDA at the end of the second quarter of 2023.
Beyond Ropidoxuridine, Shuttle is also developing a platform of
HDAC inhibitors (SP-1-161, SP-2-225 and SP-1-303), with SP-2-225
being Shuttle Pharma's lead HDAC inhibitor for preclinical
development. SP-2-225 has effects on the regulation of the immune
system. The interactions of RT with the immune response to cancers
are of great current interest, offering insight into potential
mechanisms for primary site and metastatic cancer treatment.
Shuttle Pharma is currently advancing drug manufacture and
IND-enabling studies to enable a Phase I clinical trial in
2024.
Various sources have estimated that more than 900,000 patients
are treated annually in the U.S. with radiation therapy for their
cancers. About 50% are treated for curative purposes and the
balance for palliative care. The market opportunity for radiation
sensitizers lies with the 450,000 patients treated with curative
intent. Based on a rough estimate of a course of radiation
sensitizing brand drug therapy, which are used off label at this
time, the potential market size is estimated to be in excess of
$4.5 billion annually.
About Shuttle Pharmaceuticals
Founded in 2012 by faculty members of the Georgetown
University Medical Center, Shuttle Pharma 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 Report on Form 10-Q for the quarter ended
March 31, 2023, filed with the SEC on
May 25, 2023, 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.