ropidoxuridine (IPdR) / Shuttle Pharma, National Cancer Institute - LARVOL DELTA

Ropidoxuridine in Treating Patients With Advanced Gastrointestinal Cancer Undergoing Radiation Therapy (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Biliary Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Liver Cancer • Oncology • Pancreatic Cancer • Rectal Cancer • Small Intestinal Carcinoma • Solid Tumor • CD4

Shuttle Pharma Announces Closing of $5.75 Million Underwritten Offering (GlobeNewswire) - "Shuttle Pharmaceuticals Holdings...announced today the closing of its previously announced underwritten public offering of 19,166,667 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) at a public offering price of $0.30 per share (the 'Offering'). The aggregate gross proceeds to Shuttle Pharma from the Offering was approximately $5.75 million, before deducting underwriting discounts and commissions and other offering expenses payable by Shuttle Pharma. Shuttle Pharma intends to use the net proceeds from the Offering to fund Shuttle Pharma’s Phase II clinical trial for its lead product candidate, for marketing and advertising services, and for working capital and general corporate purposes."

Commercial • Glioblastoma

Shuttle Pharma Reaches Milestone in Patient Enrollment for Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma (GlobeNewswire) - "Shuttle Pharmaceuticals Holdings...announced today that it has achieved 25% enrollment in the initial randomized portion of its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma. The Phase 2 trial design is to initially randomize 40 patients into two different dose levels, with 20 patients receiving 1,200 mg/day and 20 patients receiving 960 mg/day, to determine an optimal dose for use in glioblastoma patients. Once the optimal dose is identified, 14 additional patients will be enrolled at the optimal dose to reach statistical significance with the end-point demonstrating survival as compared to historical controls."

Enrollment status • Glioblastoma

Shuttle Pharma Expands Patient Enrollment for Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma as UVA Cancer Center Doses Its First Patient (GlobeNewswire) - "Shuttle Pharmaceuticals Holdings...announced today first patient enrollment and dosing at the UVA Cancer Center in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma. UVA is one of six cancer centers conducting the clinical trials. Shuttle Pharma previously announced the dosing of patients at Miami Cancer Institute, part of Baptist Health South Florida. The Phase 2 trial will consist initially of 40 patients randomized into two different doses (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose. Once the Company determines the optimal dose, it will then add an additional 14 patients to the trial at the optimal dose allowing for the achievement of statistical significance with the end point being that of survival as compared to historical controls."

Trial status • Glioblastoma

Shuttle Pharma Provides Third Quarter 2024 Corporate Update (GlobeNewswire) - "Shuttle Pharma’s recent highlights include the following:...Completed a $4.5 million public offering priced At-The-Market under Nasdaq rules. The Company intends to use the net proceeds from this offering to fund IND-enabling and Phase 1 and 2 clinical trials of product candidates, including payments that will be made to the clinical research organization supporting the Phase 2 clinical trial for Ropidoxuridine, and for working capital and general corporate purposes."

Financing • Glioblastoma

Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases (clinicaltrials.gov) - P1 | N=11 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2024 ➔ Oct 2025

Trial completion date • Hematological Malignancies • Oncology • Solid Tumor • CD4

Shuttle Pharma Doses First Patients in Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma (GlobeNewswire) - "Shuttle Pharmaceuticals...announced today that the first three patients in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma have been successfully dosed...The Phase 2 clinical trial will be conducted with the most aggressive brain tumors out there – IDH wild-type, methylation negative glioblastoma patients. This particular group of patients at this time only have radiation as the standard of care, with more than half of the patients surviving for less than 12 months after diagnosis. The Phase 2 trial will consist initially of 40 patients randomized into two different doses (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose....The Company expects the trial to be completed over a period of 18 to 24 months."

Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Shuttle Pharma Completes Clinical Trial Site Enrollment for Phase 2 of Ropidoxuridine for Treatment of Patients with Glioblastoma (GlobeNewswire) - "Shuttle Pharmaceuticals...announced today it has finalized agreements with all six of the planned site enrollment locations to administer the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma following the entry into agreements with Georgetown University Medical Center and UNC Medical Center. The Company previously entered agreements with UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, Allegheny Health Network (AHN) Cancer Institute, and Miami Cancer Institute, part of Baptist Health South Florida. Patients are currently undergoing screening for enrollment in the trial....Shuttle Pharma’s Phase 2 clinical trial will randomize 40 patients into two different dose groups...The Company expects the trial to be completed over the next 18 to 24 months."

Trial status • Glioblastoma

S22-11168: Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter (clinicaltrials.gov) - P2 | N=54 | Recruiting | Sponsor: Shuttle Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2024 ➔ Sep 2024

Enrollment open • Trial initiation date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Shuttle Pharma Expands Clinical Trial Site Enrollment for Phase 2 of Ropidoxuridine for Treatment of Patients with Glioblastoma (GlobeNewswire) - "Shuttle Pharmaceuticals Holdings, Inc...announced today it has entered into agreements with two additional site locations to administer the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma. Four of the planned six trial sites are now prepared to enroll patients in the clinical trial, including the UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, Allegheny Health Network (AHN) Cancer Institute, and Miami Cancer Institute, part of Baptist Health South Florida....The Company expects the trial to be completed over a period of 18 to 24 months."

Trial status • Glioblastoma

Shuttle Pharma Provides Second Quarter 2024 Corporate Update (GlobeNewswire) - "Shuttle Pharma has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for the disease....The Phase 2 clinical trial will be conducted on patients with the most aggressive brain tumors out there – IDH wild-type, methylation negative glioblastoma....Shuttle Pharma’s Phase 2 clinical trial will consist initially of 40 patients randomized into two different doses (20 @ 1,200 mg/day and 20 @ 960 mg/day)....The Company expects the trial to be completed over a period of 18 to 24 months."

Orphan drug • Trial completion date • Glioblastoma

Shuttle Pharma Ready to Enroll Patients in Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma (GlobeNewswire) - "Shuttle Pharmaceuticals Holdings, Inc...announced today it has entered into agreements with two of the six site locations to administer the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma. Site initiation visits have been completed for two sites. The trial is now open to enroll patients in the clinical trial....Shuttle Pharma expects the Phase 2 clinical trial will be carried out at six site locations, with all sites anticipated to be treating patients in the coming months."

Trial status • Glioblastoma

Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter (clinicaltrials.gov) - P2 | N=54 | Not yet recruiting | Sponsor: Shuttle Pharmaceuticals, Inc.

New P2 trial • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Shuttle Pharma Provides Fourth Quarter 2023 Corporate Update (PRNewswire) - "Shuttle Pharmaceuticals Holdings, Inc...today provided a corporate update in connection with the filing of its Annual Report on Form 10-K for the year ended December 31, 2023....'We are currently finalizing site enrollment with 'first patient, first dose' expected in the second quarter of 2024. The results of this Phase 2 clinical trial will be important as we look to leverage radiation sensitizers to increase cancer cure rates, prolong patient survival, and improve the quality of life for patients suffering from glioblastoma.'"

New P2 trial • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology

Ropidoxuridine in Treating Patients With Advanced Gastrointestinal Cancer Undergoing Radiation Therapy (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: National Cancer Institute (NCI)

Metastases • Trial completion date • Biliary Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Liver Cancer • Oncology • Pancreatic Cancer • Rectal Cancer • Small Intestinal Carcinoma • Solid Tumor • CD4

Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases (clinicaltrials.gov) - P1 | N=11 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Feb 2024 ➔ Sep 2024

Trial completion date • Hematological Malignancies • Oncology • Solid Tumor • CD4

Shuttle Pharmaceuticals Receives FDA Approval to Proceed with Phase II Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma (PRNewswire) - "Shuttle Pharmaceuticals Holdings...announced they have received the 'Safe to Proceed' letter from the U.S. Food and Drug Administration (FDA) for the Company's investigational new drug (IND) application for its Phase II study of Ropidoxuridine (IPdR) as a radiation sensitizing agent during radiotherapy in patients with newly diagnosed IDH-wildtype glioblastoma with unmethylated MGMT promoter. Receipt of the letter allows Shuttle to commence the Phase II study. Shuttle Pharma is currently finalizing site enrollment with 'first patient, first dose' expected in the coming months."

IND • New P2 trial • Glioblastoma

Shuttle Pharmaceuticals Submits IND Application to the U.S. FDA for Ropidoxuridine Phase II Clinical Trial for Patients with Glioblastoma (PRNewswire) - "Shuttle Pharmaceuticals Holdings...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.....The 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....The planned Phase II trial will investigate whether a new treatment, Ropidoxuridine, taken during radiation treatment, will be a safe and possibly effective for treatment of patients with newly diagnosed IDH-wildtype glioblastoma with unmethylated MGMT promoter."

IND • Glioblastoma

Shuttle Pharma Announces Results of Pre-IND Meeting with FDA for Ropidoxuridine Phase II Clinical Trial for Patients with Glioblastoma (PRNewswire) - "Shuttle Pharmaceuticals Holdings, Inc...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."

FDA event • IND • New P2 trial • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Shuttle Pharmaceuticals Completes Manufacturing of Active Pharmaceutical Ingredient (API) for Use in Clinical Trial (PRNewswire) - "Shuttle Pharmaceuticals Holdings, Inc...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....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."

Commercial • FDA event • New P2 trial • Trial initiation date • Brain Cancer • CNS Tumor • Oncology • Solid Tumor

A case report of typhlitis during novel use of ropidoxuridine-capecitabine-radiotherapy for treatment-naïve rectal cancer. (PubMed, Cancer Chemother Pharmacol) - P1 | "We believe this case report demonstrates the decision-making process for terminating a phase I accelerated titration designed clinical trial. The report also presents the rare complication of sigmoid typhlitis as a treatment-attributed adverse event. In this case, a ropidoxuridine-capecitabine combination was used as an investigational radiosensitizing treatment now with a narrower future clinical development pathway."

Journal • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Rectal Cancer • Solid Tumor

Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases (clinicaltrials.gov) - P1 | N=11 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | N=47 ➔ 11 | Trial primary completion date: Dec 2023 ➔ Aug 2022

Enrollment change • Trial primary completion date • Hematological Malignancies • Oncology • Solid Tumor • CD4

Testing the Addition of a Radiation Sensitizing Drug, IPdR, to the Usual Chemotherapy Treatment (Capecitabine) During Radiation Therapy for Rectal Cancer (clinicaltrials.gov) - P1 | N=1 | Terminated | Sponsor: National Cancer Institute (NCI) | N=30 ➔ 1 | Trial completion date: May 2023 ➔ Jan 2023 | Recruiting ➔ Terminated | Trial primary completion date: May 2023 ➔ Jan 2023; Inadequate accrual rate

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Rectal Cancer • Solid Tumor • CD4

Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases (clinicaltrials.gov) - P1 | N=47 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Hematological Malignancies • Oncology • Solid Tumor • CD4

Shuttle Pharmaceuticals Engages Theradex Oncology in Preparation for Clinical Study (PRNewswire) - "Shuttle Pharmaceuticals Holdings, Inc...announced it has engaged Theradex Oncology, a leading clinical research organization ('CRO'), to help prepare for its upcoming clinical study of Ropidoxuridine....Theradex Oncology will assist the Company in meetings with the FDA and preparation of the IND (Investigational New Drug) application for the planned Phase II clinical study of Ropidoxuridine and radiation therapy. Shuttle anticipates final IND application submission to the FDA in the second quarter of 2023....The reported Phase I clinical trial of Ropidoxuridine and RT supports the proposed Phase II clinical trial, through which the FDA will determine efficacy in treating brain tumors (glioblastoma). The FDA has granted approval of the Company's application for orphan-drug designation for Ropidoxuridine for the treatment of glioblastoma."

IND • Licensing / partnership • New P2 trial • Orphan drug • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor