Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq:SHPH), a US-based discovery and development stage specialty pharmaceutical company, announced on Thursday that it has signed a contract with the University of Iowa (UI) Pharmaceuticals.
The agreement has been signed for formulation development and clinical batch manufacture of drug capsules of Ropidoxuridine. This is expected to be the final step required in the drug manufacturing process for use in Shuttle Pharma's upcoming Phase II clinical trial evaluating Ropidoxuridine in combination with radiation therapy for the treatment of glioblastoma.
Shuttle Pharma has worked with TCG GreenChem, Inc. to complete the campaign to manufacture 25kg of the drug product for Ropidoxuridine, and approximately 10,000 capsules, to complete the Phase II trial. Shuttle Pharma is preparing the Investigational New Drug application for the study with an expectation of final submission to the FDA at the end of the second quarter of 2023.
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