ROCKVILLE, Md., Nov. 14,
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 September 30, 2023.
Recent Highlights
- Received written responses in September
2023 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
the Company's submission of an Investigational New Drug (IND)
application to initiate the Phase 2 clinical trial.
- Entered into an exclusive agreement to license certain
intellectual property from Georgetown
University to advance the Company's predictive biomarker
program focused on developing a predictive diagnostic test for
prostate cancer patients who are considering elective radiation
therapy. The market is expected to allow for the assessment of risk
for treatment success or failure, while informing therapeutic
decision making and follow-up management.
- Expanded the Company's patent coverage on the Company's Histone
deacetylase (HDAC) inhibitor platform.
- Manuscript published in Molecular Cancer Therapeutics reporting
on the ability of Shuttle's lead HDAC6 inhibitor drug candidate
(SP-2-225) to stimulate the innate immune system following
radiation therapy.
- Moved into new laboratory and office space to assist in
furthering the development Shuttle Pharma's lead drug candidates
and accelerate broader diagnostic capabilities on predictive
biomarkers.
- Q3 2023 operating expenses (excluding non-cash items) totaled
$1.6 million.
- At September 30, 2023, Shuttle
Pharma's cash balance was $6.8
million (including cash, cash equivalents and marketable
securities).
"During the past three months, we made significant progress on
each of our three critical cancer development programs," Dr.
Anatoly Dritschilo, Shuttle Pharma's
Chairman and CEO, stated. "First, we received positive feedback and
guidance from the FDA in the form of a Type-B PIND meeting. We
received clarification on key aspects to our Phase 2 clinical
design and CMC protocols for Ropidoxuridine, our 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. We are finalizing these protocols with an IND
submission expected in the coming days, allowing us to initiate the
Phase 2 clinical trial upon final FDA approval."
"We also completed a key step to accelerate our predictive
biomarker program for prostate cancer through the licensing of
certain intellectual property that was originally developed through
a collaboration of Shuttle Pharma scientists with investigators
from Georgetown University. We believe
our strategy to develop a predictive diagnostic test for prostate
cancer patients who are considering elective radiation therapy will
allow patients to assess their risk for treatment success or
failure, act as a cost-effective approach to inform clinicians in
their treatment recommendations, and will provide patients with a
better understanding of the benefits and risks of radiation
therapy. Importantly, given that we have collaborated with
investigators to complete the Phase 1 and Phase 2 under National
Institutes of Health Small Business Innovation Research (NIH SBIR)
contracts, we will also seek to leverage this eligibility to apply
for project bridge funding via an NIH Phase 2b SBIR mechanism to further advance the program.
Further, our recent move into a new laboratory will accommodate
our Ropidoxuridine research efforts and enhance our ability to
establish a CLIA laboratory to advance our biomarker program."
"Finally, we have published a manuscript or our scientific
findings, and expanded our patent coverage of our HDAC inhibitor
program. We look forward to advancing our developments of our lead
HDAC6 inhibitor drug candidate SP-2-225 to improve antitumor immune
responses and prevent tumor relapse post-radiation therapy."
"The coming months are expected to be exciting as we move
forward with our Phase 2 clinical trial for Ropidoxuridine, a drug
that we believe can be a key component to increase cancer cure
rates, prolong patient survival and improve quality of life," Dr.
Dritschilo concluded.
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,
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.