Business
Shuttle Pharmaceuticals Provides Second Quarter 2023 Corporate Update
ROCKVILLE, Md., Aug. 15, 2023 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty
About this update from Shuttle Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"ROCKVILLE, Md., Aug. 15, 2023 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today provided a corporate update in connection with the filing of its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023.\n\n \n \n \n \n \n \n\n \nRecent Highlights\nOn track to commence Phase II clinical study in the fourth quarter of 2023 for Ropidoxuridine, Shuttle Pharma's lead clinical sensitizer drug candidate.Successfully completed the initial manufacturing campaign for the active pharmaceutical ingredient (API) of Ropidoxuridine for use in the Shuttle Pharma's upcoming Phase II clinical trial.Received approval for a Type B pre-IND meeting with the FDA for guidance on the proposed Phase II clinical trial with a goal of receiving written responses from the FDA by September 18, 2023.Moved into new laboratory and office space to assist in furthering the development Shuttle Pharma's lead drug candidates and accelerate broader diagnostic capabilities on predictive biomarkers.Q2 2023 operating expenses (excluding non-cash items) totaled $1.5 million.At June 30, 2023, Shuttle Pharma's cash balance was $8.4 million (including cash, cash equivalents and marketable securities).\"We are making significant progress in the advancement of Ropidoxuridine, our lead clinical sensitizer drug candidate, for treatment in brain cancer patients undergoing radiation therapy. During the last few months, we successfully completed the initial manufacturing campaign for the API to be used in the upcoming Phase II clinical trial and received approval from the FDA for a Type B pre-IND meeting to receive guidance on the trial design,\" commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. \"We expect to receive comments from the FDA by mid-September which would put us in position to initiate the clinical trial in the fourth quarter of this year — a significant inflection point in the development of Ropidoxuridine.\"\n\"The move into our new laboratory will accommodate not only our Ropidoxuridine research efforts, but also enhance our ability to establish a CLIA laboratory to advance our diagnostic intellectual property that has been developed with funding from NIH smal...