ROCKVILLE, Md., Aug. 15,
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 June 30, 2023.
Recent Highlights
- On track to commence Phase II clinical study in the fourth
quarter of 2023 for Ropidoxuridine, Shuttle Pharma's lead clinical
sensitizer drug candidate.
- Successfully completed the initial manufacturing campaign for
the active pharmaceutical ingredient (API) of Ropidoxuridine for
use in the Shuttle Pharma's upcoming Phase II clinical trial.
- Received approval for a Type B pre-IND meeting with the FDA for
guidance on the proposed Phase II clinical trial with a goal of
receiving written responses from the FDA by September 18, 2023.
- 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.
- Q2 2023 operating expenses (excluding non-cash items) totaled
$1.5 million.
- At June 30, 2023, Shuttle
Pharma's cash balance was $8.4
million (including cash, cash equivalents and marketable
securities).
"We are making significant progress in the advancement of
Ropidoxuridine, our lead clinical sensitizer drug candidate, for
treatment in brain cancer patients undergoing radiation therapy.
During the last few months, we successfully completed the initial
manufacturing campaign for the API to be used in the upcoming Phase
II clinical trial and received approval from the FDA for a Type B
pre-IND meeting to receive guidance on the trial design," commented
Shuttle Pharma's Chairman and CEO, Anatoly
Dritschilo, M.D. "We expect to receive comments from the FDA
by mid-September which would put us in position to initiate the
clinical trial in the fourth quarter of this year — a significant
inflection point in the development of Ropidoxuridine."
"The move into our new laboratory will accommodate not only our
Ropidoxuridine research efforts, but also enhance our ability to
establish a CLIA laboratory to advance our diagnostic intellectual
property that has been developed with funding from NIH small
business innovative (SBIR) research contracts over the past several
years, particularly for our predictive biomarker capabilities for
prostate cancer patients. We are eligible for NIH SBIR 'bridge'
support to assist in funding the advancements of these efforts. Our
recently published work in premier cancer journals provides insight
into the immune response taking place in patients after radiation
therapy for cancer and informs therapeutic strategies for
sequencing radiation and immune therapy modalities for cancer
treatment," 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 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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/shuttle-pharmaceuticals-provides-second-quarter-2023-corporate-update-301900007.html
SOURCE Shuttle Pharmaceuticals Holdings, Inc.