Shuttle Pharma Submits Ropidoxuridine IND for Glioblastoma Treatment to FDA

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Shuttle Pharma Submits Ropidoxuridine IND for Glioblastoma Treatment to FDA

Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”) has announced a significant stride in its mission to address glioblastoma, a lethal brain malignancy. The company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to facilitate the next phase of Ropidoxuridine development.

Ropidoxuridine and its Role in Glioblastoma Treatment

Ropidoxuridine, Shuttle Pharma’s lead radiation sensitizer candidate, is designed for use in combination with radiation therapy (RT) to treat glioblastoma, a form of brain cancer with limited treatment options. The company aims to enhance the effectiveness of radiation, ultimately increasing cancer cure rates, extending patient survival, and improving the quality of life when used alone or in conjunction with surgery, chemotherapy, and immunotherapy.

Milestone IND Submission

The IND submission marks a critical milestone in Shuttle Pharma’s journey. This step follows positive feedback received during a Type B pre-Investigational New Drug Application (PIND) meeting with the FDA in September 2023. The FDA’s responses provided guidance on the Chemistry, Manufacturing, and Controls (CMC) and clinical protocol design for Ropidoxuridine, paving the way for the current IND submission.

An IND application is a formal request to regulatory authorities, providing detailed information about the drug, its composition, preclinical studies’ toxicology data, proposed clinical trial protocols, and manufacturing and quality control details. The FDA is expected to provide a decision on proceeding with the Phase II trial within approximately 30 days.

Phase II Trial Focus and Potential Impact

The upcoming Phase II trial will assess the safety and potential efficacy of Ropidoxuridine when administered during radiation treatment for patients with newly diagnosed IDH-wildtype glioblastoma with an unmethylated MGMT promoter.

Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D., stated, “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. This IND submission is an important next step in making this mission a reality.”

Market Opportunities and Regulatory Designation

With an estimated 800,000 U.S. patients undergoing radiation therapy annually, the market potential for radiation sensitizers is substantial. Shuttle Pharma has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for glioblastoma treatment.

About Shuttle Pharmaceuticals

Founded in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharmaceuticals focuses on discovery and development in the specialty pharmaceutical space, specifically aiming to improve outcomes for cancer patients treated with radiation therapy. The company seeks to maximize the effectiveness of radiation while minimizing side effects, addressing a critical need in cancer treatment.

Safe Harbor Statement

This press release contains forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements due to various factors. Please refer to Shuttle Pharma’s SEC filings for a discussion of risk factors. The company disclaims any obligation to update forward-looking statements.

Note: This press release is for informational purposes only and does not constitute an endorsement or recommendation of Shuttle Pharmaceuticals or its products.