Shuttle Pharma Provides Third Quarter 2024 Corporate Update
14 11월 2024 - 7:00AM
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle
Pharma” or the “Company”), 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 third quarter ended September 30, 2024.
Shuttle Pharma’s recent highlights include the following:
- Successfully dosed
first three patients in the Phase 2 clinical trial of
Ropidoxuridine for the treatment of patients with brain tumors
(glioblastoma). Ropidoxuridine is Shuttle Pharma's lead candidate
radiation sensitizer for use in combination with RT to treat
glioblastoma, a deadly malignancy of the brain with no known cure.
Additional patients are currently undergoing screening for
enrollment in the trial.
- Finalized agreements
with all six of the planned site enrollment locations which will be
administering the Phase 2 clinical trial following the Company’s
entry into agreements with Georgetown University Medical Center and
UNC Medical Center. The Company previously entered agreements with
the UVA Cancer Center, John Theurer Cancer Center at Hackensack
University Medical Center, Allegheny Health Network (AHN) Cancer
Institute, and Miami Cancer Institute, part of Baptist Health South
Florida.
- Paid off the
entirety of the outstanding balance due under Shuttle Pharma’s
Senior Secured Convertible Note issued on January 11, 2023. The
initial balance of the Note was $4.3 million and was originally
repayable over a 26-month period ending March 11, 2025.
- Completed a $4.5
million public offering priced At-The-Market under Nasdaq rules.
The Company intends to use the net proceeds from this offering to
fund IND-enabling and Phase 1 and 2 clinical trials of product
candidates, including payments that will be made to the clinical
research organization supporting the Phase 2 clinical trial for
Ropidoxuridine, and for working capital and general corporate
purposes.
- The Company also
closed on a convertible note and warrant offering, receiving a
total of $790,000 in gross proceeds, including $237,500 invested by
the Company’s Chief Executive Officer, Dr. Anatoly Dritschilo.
- Cash balance as of
October 31, 2024 was $4.1 million.
“We made tremendous progress over the past few months to advance
our Phase 2 clinical trial of Ropidoxuridine for the treatment of
patients with glioblastoma, with the first three patients dosed in
October 2024,” stated Shuttle Pharma’s Chairman and CEO, Anatoly
Dritschilo, M.D. “The initial patient dosing followed the
successful engagement of all six of the planned clinical trial site
locations, each of which are nationally recognized cancer centers
that are most likely to treat IDH wild-type, methylation negative
glioblastoma patients – the target of the clinical trial. The
initiation of the Phase 2 trial is a significant milestone for both
Shuttle Pharma and the thousands of patients with brain tumors who
currently lack effective therapies.”
“Beyond these critical clinical developments, we also made
progress in improving our balance sheet and funding the Phase 2
clinical trial. I want to thank all of the investors who have
committed to helping us advance our mission to leverage radiation
sensitizers to increase cancer cure rates, prolong patient survival
and improve quality of life for patients suffering from
glioblastoma,” Dr. Dritschilo concluded.
About the Phase 2 Clinical Trial
The Phase 2 clinical trial has begun enrolling 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 initially
consist 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, it will then add an
additional 14 patients 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.
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.
More information about Shuttle Pharma’s Phase 2 study
(NCT06359379) can be found at www.clinicaltrials.gov.
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. Shuttle Pharma’s Chairman
and CEO, Dr. Anatoly Dritschilo, is currently Professor Emeritus at
the Georgetown University Medical Center. 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
Shuttle Pharmaceuticals (NASDAQ:SHPH)
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부터 11월(11) 2024 으로 12월(12) 2024
Shuttle Pharmaceuticals (NASDAQ:SHPH)
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부터 12월(12) 2023 으로 12월(12) 2024