Shuttle Pharmaceuticals Submits IND Application to the U.S. FDA for Ropidoxuridine Phase II Clinical Trial for Patients with Glioblastoma

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[{"type":"text","content":"ROCKVILLE, Md., Dec. 11, 2023 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (\"Shuttle Pharma\") today announced submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to support the next phase of development of Ropidoxuridine. Ropidoxuridine is Shuttle Pharma's lead radiation sensitizer candidate for use in combination with radiation therapy (RT) to treat brain tumors (glioblastoma), a deadly malignancy of the brain with no known cure.\n\n \n \n \n \n \n \n\n \nRT is a proven modality for treating cancers. However, there is a significant need in the market to make radiation more effective. By developing radiation sensitizers, Shuttle Pharma aims 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.\n\"Today's announcement is an important milestone for Shuttle Pharma and the thousands of patients with brain tumors who currently lack effective therapies,\" stated Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. \"The IND submission is the culmination of many years of clinical development by the Shuttle Pharma team, as well as support from the broader cancer community, including the National Institutes of Health's National Cancer Institute and Small Business Innovation Research program, who have provided guidance and grant funding to bring this potentially important new radiation sensitizing therapy to market.\"\nAn IND submission is a request submitted to the regulatory authorities seeking permission to test a new drug or therapeutic substance in humans. The submission includes detailed information about the drug, its composition, pharmacology, toxicology data from preclinical studies, proposed clinical trial protocols, and information on manufacturing and quality control. With the IND application submission now complete, the FDA is expected to provide Shuttle Pharma with its decision to proceed with the Phase II trial within approximately 30 days.\nThe submission of the IND follows recent receipt of written responses to questions submitted for a Type B pre-Investigational New Drug Application (PIND) meeting with the FDA in September 2023. During the PIND meeting, the FDA provided positive feedback and guidance on th...

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