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Shuttle Pharmaceuticals Holdings, Inc. (NASDAQ: SHPH) generates news at the intersection of oncology drug development and artificial intelligence–driven molecular discovery. Public updates highlight the company’s efforts to improve outcomes for cancer patients treated with radiation therapy, as well as its ownership and deployment of the Molecule.ai platform, a pharmaceutical software AI-driven system for molecular discovery and early-stage drug development.
Recent news releases describe several key themes. Shuttle Pharma has reported on its historical Phase II clinical trial of Ropidoxuridine (IPdR) in glioblastoma patients undergoing radiation therapy, including enrollment progress and tolerability data, and later on its decision to discontinue those clinical trials and initiate winddown activities in coordination with its contract research organization and clinical sites. These items provide context on the evolution of the company’s oncology pipeline and its strategic reassessment of clinical programs.
Another major news focus is the acquisition and integration of Molecule.ai. Press releases and 8-K filings detail a binding term sheet, asset purchase agreement and closing of the transaction under which a Shuttle Pharma subsidiary acquired substantially all of the assets and liabilities of the Canadian AI company operating Molecule.ai. Coverage explains how the platform supports molecular property prediction, drug-target interaction modeling, cross-property evaluation and structured reasoning, and how Shuttle Pharma aims to use these capabilities to augment its drug discovery and development activities.
News items also address capital markets and regulatory developments, such as a private placement involving a pre-funded warrant, related S-1 and S-1/A registration statements for resale of the underlying shares, and communications regarding Nasdaq listing requirements and a reverse stock split undertaken as part of a compliance initiative. Together, these disclosures offer investors and observers a view into SHPH’s scientific programs, AI platform strategy, financing transactions and listing status.
For readers following SHPH news, the company’s updates provide ongoing insight into its transition from a radiation-sensitizer–focused clinical-stage pharmaceutical profile toward a combined biotechnology and AI-driven molecular discovery business model.
Shuttle Pharmaceuticals (Nasdaq: SHPH) has initiated patient dosing in its Phase 2 Clinical Trial of Ropidoxuridine, a radiation sensitizer for treating glioblastoma brain tumors. The trial involves 40 patients initially randomized into two dosage groups (1,200 mg/day and 960 mg/day), with plans to add 14 more patients once the optimal dose is determined. The study targets IDH wild-type, methylation negative glioblastoma patients, who currently have treatment options with radiation therapy. The trial is expected to complete in 18-24 months. Ropidoxuridine has received FDA Orphan Drug Designation, potentially providing marketing exclusivity upon approval.
Shuttle Pharmaceuticals (Nasdaq: SHPH) has completed enrollment of six clinical trial sites for its Phase 2 study of Ropidoxuridine, a radiation sensitizer for treating glioblastoma. The trial sites include Georgetown University Medical Center, UNC Medical Center, UVA Cancer Center, John Theurer Cancer Center, Allegheny Health Network Cancer Institute, and Miami Cancer Institute. The study will randomize 40 patients into two dose groups (1,200 mg/day and 960 mg/day) to determine optimal dosing, followed by an additional 14 patients for survival endpoint comparison. The trial is expected to complete in 18-24 months. Ropidoxuridine has received FDA Orphan Drug Designation for brain tumor treatment.
Shuttle Pharmaceuticals (Nasdaq: SHPH) announced its CEO, Dr. Anatoly Dritschilo, will present at the 2024 ThinkEquity Conference on October 30, 2024, at 8:30 am ET. The presentation will highlight updates on the company's Phase 2 Clinical Trial of Ropidoxuridine for glioblastoma treatment and plans for Shuttle Diagnostics to develop predictive biomarkers for prostate cancer radiation therapy outcomes.
The conference will be held at the Mandarin Oriental Hotel in New York, featuring one-on-one meetings with investors. The presentation will be accessible via webcast through the company's website and the conference platform. Shuttle Pharmaceuticals focuses on improving outcomes for cancer patients treated with radiation therapy by developing radiation sensitizers.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) has expanded its Phase 2 clinical trial for Ropidoxuridine, a radiation sensitizer for treating glioblastoma patients. The company has added two more site locations, bringing the total to four out of six planned sites ready to enroll patients. These include UVA Cancer Center, John Theurer Cancer Center, Allegheny Health Network Cancer Institute, and Miami Cancer Institute.
The trial targets IDH wild-type, methylation negative glioblastoma patients, aiming to improve outcomes for this aggressive brain cancer. Ropidoxuridine has received Orphan Drug Designation from the FDA. The study will initially enroll 40 patients, testing two dosage levels, with an additional 14 patients added later to achieve statistical significance. Shuttle Pharma expects the trial to be completed in 18 to 24 months.
Shuttle Pharmaceuticals, a specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy, has announced the issuance of U.S. Patent No. 12,077,515 for Selective Histone Deacetylase Inhibitors for the Treatment of Human Disease. The patent, issued on September 3, 2024, covers a series of selective HDAC inhibitors designed to modulate gene expression involved in cancer progression and immune responses.
This patent strengthens Shuttle Pharma's intellectual property portfolio, supporting its efforts to develop novel therapeutics targeting histone deacetylase (HDAC) enzymes. The company's HDAC platform aims to develop cancer immunotherapies and has potential applications in autoimmune, inflammatory, metabolic, neurological, and infectious diseases. Shuttle Pharma now holds over 20 composition of matter HDAC inhibitor patents in the U.S., Canada, and Europe.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) has provided a corporate update for Q2 2024. Key highlights include:
1. Enrollment has begun in the Phase 2 clinical trial of Ropidoxuridine for glioblastoma treatment.
2. Two out of six planned site locations are ready to treat patients.
3. Shuttle Pharma received FDA Orphan Drug Designation for Ropidoxuridine.
4. The trial will involve 40 patients initially, with an additional 14 patients once the optimal dose is determined.
5. The company has regained compliance with Nasdaq's Listing Rule 5250(c) after filing delayed financial reports.
Shuttle Pharma aims to improve outcomes for cancer patients treated with radiation therapy by developing radiation sensitizers.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) has announced that it has regained compliance with Nasdaq's Minimum Bid Price Rule. The company's stock traded above $1.00 per share for ten consecutive trading days, meeting the requirement as of August 27, 2024. Shuttle Pharma, founded in 2012 by Georgetown University Medical Center faculty members, is a specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy.
The company's mission is to develop radiation sensitizers that enhance the effectiveness of radiation therapy while reducing side effects. Shuttle Pharma aims to increase cancer cure rates, prolong patient survival, and improve quality of life when used as a primary treatment or in combination with other therapies.
Shuttle Pharmaceuticals Holdings (Nasdaq: SHPH) has received a notice of non-compliance from Nasdaq due to its failure to timely file its Q2 2024 Quarterly Report. This non-compliance stems from an ongoing re-audit of the company's 2022 financial statements, necessitated by SEC sanctions against its former auditor. Shuttle Pharma is preparing amended reports for 2023 and Q1 2024, which will include restated 2022 financials.
The company expects to file these reports soon, followed by the Q2 2024 report, to regain compliance automatically. If more time is needed, Shuttle Pharma has 60 days to submit a compliance plan to Nasdaq and could receive up to 180 days to regain compliance. The notice does not immediately affect the company's Nasdaq Capital Market listing.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) has announced readiness to enroll patients in a Phase 2 clinical trial of Ropidoxuridine for treating glioblastoma. The trial, focusing on IDH wild-type, methylation negative glioblastoma patients, will initially involve 40 patients randomized into two dosage groups. An additional 14 patients will be added once the optimal dose is determined. The study aims to improve survival rates compared to historical controls.
Ropidoxuridine, Shuttle Pharma's lead radiation sensitizer, has received Orphan Drug Designation from the FDA. The trial is expected to be completed in 18 to 24 months across six site locations. This study is important for the cancer community, potentially increasing cure rates and improving patient outcomes for this aggressive brain tumor.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) has announced the publication of a manuscript in PLOS ONE detailing the effectiveness of their pre-clinical HDAC inhibitor asset, SP-1-303. The study shows that SP-1-303 activates ATM protein and modulates estrogen receptor expression, resulting in significant growth inhibition of estrogen receptor positive breast cancer cells (ER + BC).
SP-1-303, developed in Shuttle Pharma's laboratories, is a selective Class I HDAC inhibitor that targets HDAC1, 3, and 6. It demonstrates direct cellular toxicity in ER + BC and increases PD-L1 expression, suggesting potential for combination therapy with immune checkpoint blockers. The research, conducted by Dr. Mira Jung and Dr. Scott Grindrod, highlights SP-1-303's promising therapeutic approach for treating ER + breast cancers.