Shuttle Pharma Provides Second Quarter 2024 Corporate Update
05 9월 2024 - 5:15AM
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle
Pharma”), 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 second quarter ended June 30, 2024.
Shuttle Pharma’s recent highlights include the following:
- Enrollment of
patients in the Phase 2 clinical trial of Ropidoxuridine for the
treatment of patients with glioblastoma has recently opened
following the entry of agreements with two site locations to
administer the trial. Ropidoxuridine (IPdR) is Shuttle Pharma'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 Pharma
expects the Phase 2 clinical trial will be carried out at six site
locations, with two sites now ready to start treating patients and
all sites anticipated to be treating patients in the coming
months.
- Shuttle Pharma has
received Orphan Drug Designation from the FDA, providing potential
marketing exclusivity upon first FDA approval for the disease.
“We achieved a significant milestone recently with the
commencement of our Phase 2 clinical trial of Ropidoxuridine for
the treatment of patients with glioblastoma now officially underway
and ready to enroll patients,” stated Shuttle Pharma’s Chairman and
CEO, Anatoly Dritschilo, M.D. “To date, we have entered into
agreements with two of the planned six site locations with an
additional four sites set to come on board in September. The two
initial sites have completed site initiation visits and are fully
ready to begin treating patients. The results of this Phase 2
clinical trial will determine clinical efficacy of Ropidoxuridine
as a radiation sensitizer with the goal of increasing cancer cure
rates, prolonging patient survival, and improving the quality of
life for patients suffering from glioblastoma.”
The Phase 2 clinical trial will be conducted on patients with
the most aggressive brain tumors out there – IDH wild-type,
methylation negative glioblastoma. Presently, radiation is the only
approved standard of care for this particular group of patients,
with more than half of the patients surviving for less than 12
months after diagnosis. Shuttle Pharma’s Phase 2 clinical trial
will consist initially of 40 patients randomized into two different
doses (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an
optimal dose. Once the Company determines the optimal dose, then an
additional 14 patients will be enrolled on the optimal dosage
allowing for the achievement of statistical significance with the
end point being that of survival as compared to historical
controls. The Company expects the trial to be completed over a
period of 18 to 24 months.
“Reaching this important milestone of putting drug into patients
doesn’t happen overnight,” stated Dr. Dritschilo. “There are a
number of critical steps we have executed on during these past two
years to reach this point, including the manufacturing of the
active pharmaceutical ingredient (API) of Ropidoxuridine by our
contractor TCG GreenChem and formulation into the drug product by
the University of Iowa Pharmaceuticals I simply couldn’t be more
pleased with how diligently our team has worked to execute the
required steps necessary to initiate this clinical trial. We are
now one step closer to achieving our mission of improving 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.”
Nasdaq Update:
Due to the recent SEC sanctions against B.F. Borgers, CPA, PC,
an auditor previously engaged by Shuttle Pharma, a re-audit of
prior years’ financial statements has been required and was
performed by Shuttle Pharma’s current auditors, Forvis Mazars, LLP.
This re-audit caused a delay in filing our Quarterly Report on Form
10-Q for the period ended June 30, 2023 (the “Q2 Quarterly
Report”). As a result, on August 21, 2024, Shuttle Pharma received
notice from the Nasdaq Stock Exchange, LLC that it had fallen out
of compliance with Nasdaq’s Listing Rule 5250(c) for not timely
filing the Q2 Quarterly Report. As of today’s date, Shuttle Pharma
has now filed its Annual Report on Form 10-K/A for the fiscal year
ended December 31, 2023, including the re-audited information, as
well as its Quarterly Report on Form 10-Q/A for the period ended
March 31, 2024 and the Q2 Quarterly Report. Following these
filings, Shuttle Pharma has now regained compliance with Listing
Rule 5250(c).
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, 2023, as amended, filed with the SEC on
September 4, 2024, 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 PharmaceuticalsAnatoly
Dritschilo, M.D., CEO240-403-4212info@shuttlepharma.com
Investor ContactsLytham Partners, LLCRobert
Blum602-889-9700shph@lythampartners.com
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