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 that TCG GreenChem has successfully completed the initial manufacturing campaign for the active pharmaceutical ingredient (API) of Ropidoxuridine for use in the Company's upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy.
"Shuttle has been working concomitantly with TCG GreenChem to manufacture API and University of Iowa Pharmaceuticals to develop the formulation and packaging of the drug product into capsules for clinical use. Today's announcement of successfully completing the API manufacturing is an important step in the advancement Ropidoxuridine, our lead clinical sensitizer drug candidate, towards the commencement of our upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy," commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D.
In addition, Shuttle's recent request for a Type B pre-IND meeting with the FDA for guidance on the proposed Phase II clinical trial has been approved with a goal of receiving written responses from the FDA by September 18, 2023. With this, the Company believes it remains on track to commence its Phase II clinical study in the fourth quarter of 2023.
Recent SHPH News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/14/2024 01:00:22 PM
- Shuttle Pharma Provides First Quarter 2024 Corporate Update • GlobeNewswire Inc. • 05/14/2024 01:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/13/2024 09:01:59 PM
- Shuttle Pharmaceuticals to Present at the Planet MicroCap Showcase: VEGAS 2024 on Wednesday, May 1, 2024 & 1x1 Meetings on Thursday, May 2, 2024 • GlobeNewswire Inc. • 04/23/2024 08:15:00 PM
- Shuttle Pharma Provides Fourth Quarter 2023 Corporate Update • PR Newswire (US) • 03/22/2024 01:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 11:18:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/05/2024 02:00:29 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/13/2024 01:00:16 PM
- Shuttle Pharma Announces Its Intent to Pursue a Rights Offering • PR Newswire (US) • 02/13/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/05/2024 09:25:13 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 01/08/2024 02:05:10 PM
- Shuttle Pharmaceuticals Receives FDA Approval to Proceed with Phase II Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma • PR Newswire (US) • 01/08/2024 02:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2024 10:10:30 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/21/2023 02:51:28 AM
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- Form 8-K - Current report • Edgar (US Regulatory) • 12/11/2023 02:00:12 PM
- Shuttle Pharmaceuticals Submits IND Application to the U.S. FDA for Ropidoxuridine Phase II Clinical Trial for Patients with Glioblastoma • PR Newswire (US) • 12/11/2023 02:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/30/2023 02:00:25 PM
- Shuttle Pharmaceuticals Provides Third Quarter 2023 Corporate Update • PR Newswire (US) • 11/14/2023 02:00:00 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 09:14:44 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 10/20/2023 08:15:34 PM
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