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Shuttle Pharma Announces Results of Pre-IND Meeting with FDA for Ropidoxuridine Phase II Clinical Trial for Patients with Glioblastoma
Company remains on track to initiate the clinical trial in Q4 of 2023 ROCKVILLE, Md., Sept. 25, 2023 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc.
About this update from Shuttle Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"Company remains on track to initiate the clinical trial in Q4 of 2023\nROCKVILLE, Md., Sept. 25, 2023 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), today announced receipt of written responses to questions submitted for a Type B pre-Investigational New Drug Application (PIND) meeting with the U.S. Food and Drug Administration (FDA). The FDA's positive feedback and guidance on the Company's Chemistry, Manufacturing, and Controls (CMC) and clinical protocol design for Ropidoxuridine provides a pathway to IND application submission in the fourth quarter of 2023 to initiate the Phase 2 clinical trial.\n\n \n \n \n \n \n \n\n \n\"The FDA's written responses provide clarification and guidance on key aspects to our Phase 2 clinical design and CMC protocols, paving the way to Shuttle's clinical development of Ropidoxuridine as a radiation sensitizer for treating glioblastoma,\" commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D.\nRopidoxuridine (IPdR) is Shuttle'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 has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for the disease.\nAbout Shuttle Pharmaceuticals\nFounded 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.\nSafe Harbor Statement\nStatements in this press r...