Shuttle Pharmaceuticals Receives FDA Approval to Proceed with Phase II Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma

Rhea-AI Summary

Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) has received the 'Safe to Proceed' letter from the FDA for its Phase II study of Ropidoxuridine as a radiation sensitizing agent for glioblastoma. The company is finalizing site enrollment and expects the 'first patient, first dose' in the coming months. Ropidoxuridine is the company's lead candidate for use in combination with radiation therapy to treat glioblastoma, a deadly brain malignancy with no known cure.

Oncology Doctor

The 'Safe to Proceed' letter from the FDA for Shuttle Pharma's IND application marks a significant step in the development of Ropidoxuridine as a potential treatment for glioblastoma. As an oncologist, the progression to a Phase II clinical trial is a critical juncture in assessing the efficacy and safety of this radiation sensitizer. Glioblastoma remains one of the most aggressive and lethal forms of brain cancer, with limited treatment options. The use of Ropidoxuridine, if proven effective, could enhance the therapeutic impact of radiotherapy, potentially extending survival and improving the quality of life for patients.

Historically, the treatment landscape for glioblastoma has been challenging due to the tumor's resistance to conventional therapies and its rapid progression. The introduction of a radiation sensitizer like Ropidoxuridine could represent a paradigm shift in the management of glioblastoma. It's essential to monitor the clinical outcomes of this Phase II study closely, as it will provide valuable insights into the drug's performance and possible side effects when used in conjunction with standard radiation therapy.

Medical Research Analyst

Shuttle Pharma's announcement concerning its Phase II study is a noteworthy development in the oncology research field. The focus on IDH-wildtype glioblastoma with unmethylated MGMT promoter is particularly important as these genetic markers are associated with poorer prognosis and resistance to certain therapies, including alkylating agents. The investigation of Ropidoxuridine aims to address a significant unmet need in this patient population.

From a research perspective, the design and outcomes of this trial will contribute to our understanding of how radiation sensitizers can be integrated into existing treatment protocols. Moreover, the success of Ropidoxuridine could stimulate further investment and research into similar compounds, potentially leading to a new class of adjuvant therapies in oncology. The financial implications for Shuttle Pharma hinge on the trial results, which could pave the way for further funding, partnerships and ultimately, FDA approval for wider use if the data is positive.

Market Research Analyst

The advancement of Shuttle Pharma's Ropidoxuridine into Phase II trials is a crucial development for stakeholders in the pharmaceutical and biotech industries. With an estimated 800,000 patients in the US undergoing radiation therapy annually, the market potential for an effective radiation sensitizer is substantial. Should Ropidoxuridine demonstrate significant improvements in treatment outcomes, it could capture a considerable share of the oncology adjuvant market.

Investors and industry analysts will be closely monitoring the progress of this study, as positive results could lead to a surge in Shuttle Pharma's stock valuation. Conversely, any setbacks or negative outcomes could have a detrimental effect on investor confidence. The long-term impact on the company's financial health and market position will largely depend on the clinical success of Ropidoxuridine and its subsequent commercialization strategy.

ROCKVILLE, Md., Jan. 8, 2024 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) ("Shuttle Pharma") today announced they have received the 'Safe to Proceed' letter from the U.S. Food and Drug Administration (FDA) for the Company's investigational new drug (IND) application for its Phase II study of Ropidoxuridine (IPdR) as a radiation sensitizing agent during radiotherapy in patients with newly diagnosed IDH-wildtype glioblastoma with unmethylated MGMT promoter. Receipt of the letter allows Shuttle to commence the Phase II study.

Shuttle Pharma is currently finalizing site enrollment with 'first patient, first dose' expected in the coming months. Ropidoxuridine is Shuttle Pharma's lead radiation sensitizer candidate for use in combination with radiation therapy (RT) to treat glioblastoma, a deadly malignancy of the brain with no known cure.

"We are excited to have been granted approval to commence Ropidoxuridine's Phase II clinical trial following the receipt of the FDA's 'Safe to Proceed' letter," stated Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. "Radiation therapy is a proven modality for treating cancers. However, there is a significant need in the market to make radiation more effective. The results of this Phase II clinical trial will be important as we look to leverage radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma."

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.

Shuttle Pharma has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for the disease.

About Shuttle Pharmaceuticals

Founded in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharmaceuticals 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.

What did Shuttle Pharmaceuticals Holdings, Inc. receive from the FDA?

Shuttle Pharmaceuticals Holdings, Inc. received the 'Safe to Proceed' letter from the FDA for its Phase II study of Ropidoxuridine as a radiation sensitizing agent for glioblastoma.

What is the ticker symbol for Shuttle Pharmaceuticals Holdings, Inc.?

The ticker symbol for Shuttle Pharmaceuticals Holdings, Inc. is SHPH.

What is the Phase II study for Ropidoxuridine?

The Phase II study is for evaluating Ropidoxuridine as a radiation sensitizing agent during radiotherapy in patients with newly diagnosed IDH-wildtype glioblastoma with unmethylated MGMT promoter.

What is the expected timeline for the 'first patient, first dose' for the Phase II study?

The company is finalizing site enrollment and expects the 'first patient, first dose' in the coming months.

What is glioblastoma?

Glioblastoma is a deadly malignancy of the brain with no known cure.