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About Shuttle Pharmaceuticals Holdings Inc
Shuttle Pharmaceuticals Holdings Inc is a clinical-stage biopharmaceutical company focused on the development of innovative radiation sensitizers and selective HDAC inhibitors. Founded by faculty members of a renowned medical center, the company is deeply rooted in cutting-edge research and clinical innovation, strategically positioned to address unmet needs in the treatment of cancer.
Utilizing its proprietary technology, Shuttle Pharmaceuticals is dedicated to enhancing the efficacy of radiation therapy (RT) by integrating its novel therapeutic candidates with standard treatment modalities. This includes not only the adjunctive use with surgery, chemotherapy, and immunotherapy but also optimizing outcomes in patients undergoing radiation treatment. Through its pioneering work, the company is developing products that aim to sensitize tumors to radiation while protecting surrounding healthy tissues from adverse effects.
Therapeutic Focus and Pipeline
The company’s robust pipeline is centered on two major therapeutic programs:
- Radiation Sensitization: Shuttle Pharmaceuticals is advancing its lead candidate, Ropidoxuridine (IPdR), designed to enhance the cytotoxic effects of radiation on brain tumors, specifically targeting glioblastoma—a challenging malignancy where current treatment options are limited.
- Selective HDAC Inhibitors: The company’s portfolio includes novel HDAC inhibitors, such as SP-1-303, which exploits the potential of inhibiting class I HDACs and modulating ATM activity. This dual-target approach not only sensitizes cancer cells to radiation but also activates immune responses, providing a multifaceted strategy against cancers like estrogen receptor-positive breast cancer.
Clinical Development and Research Excellence
Shuttle Pharmaceuticals is recognized for its methodical approach to clinical research, with its Phase 2 clinical trial for Ropidoxuridine already underway at several nationally recognized cancer centers. The trial is designed to evaluate optimal dosing regimens in patients with aggressive glioblastoma, showcasing the company’s commitment to rigorous clinical standards and robust data-driven decision making. Its research extends beyond immediate clinical application, delving into diagnostics and theranostic approaches that could further refine treatment paradigms in oncology.
Innovative Technology and Industry Impact
At the core of Shuttle Pharmaceuticals' operations is a blend of advanced molecular pharmacology and clinical insight. The company leverages its proprietary HDAC platform to identify and develop drug candidates that selectively modulate gene expression involved in cancer progression and the immune response. This strategic use of technology not only advances cancer therapy but also contributes to broader biomedical research in areas such as autoimmune and inflammatory diseases.
Competitive Position and Market Context
Operating in the competitive and dynamic oncology sector, Shuttle Pharmaceuticals distinguishes itself through its singular focus on radiation sensitization—a critical component in improving the outcomes of radiation therapy. Despite challenges such as rigorous regulatory requirements and the high costs associated with clinical trials, its deep scientific expertise and academic backing provide a strong foundation for overcoming these hurdles. The company is a significant entity in its niche, strategically differentiating its offerings by combining novel drug candidates with advanced delivery protocols aimed at enhancing the precision and safety of cancer treatments.
Commitment to Scientific Rigor and Patient Outcomes
Every aspect of Shuttle Pharmaceuticals’ operations echoes a commitment to improving patient outcomes without compromising safety. By maintaining stringent research protocols and engaging with collaborative research institutions, the company not only educates the scientific community but also ensures that every advancement is thoroughly validated and transparently reported. This approach builds trust among clinical peers, investors, and regulatory bodies, reinforcing its reputation as a credible and reliable innovator in the field of oncology.
In summary, Shuttle Pharmaceuticals Holdings Inc epitomizes a blend of scientific innovation and applied clinical research. Its focus on maximizing the effectiveness of traditional radiation therapy through novel sensitizers and targeted inhibitors positions it as a resourceful player within the oncology sector—driving forward research that may one day transform the treatment landscape for some of the most challenging cancers.
Shuttle Pharmaceuticals (Nasdaq: SHPH) has fully paid off its Senior Secured Convertible Note issued in January 2023, which had an initial balance of $4.3 million. The company made $1.3 million in cash payments and issued 1,094,970 shares, bringing total outstanding shares to 2,946,099. In October 2024, the company secured $790,000 in gross proceeds through a convertible note and warrant offering, including $237,500 from CEO Dr. Anatoly Dritschilo.
The company is advancing its Phase 2 clinical trial for glioblastoma treatment, with five out of six trial sites ready to begin treating patients. The trial will initially include 40 patients randomized into two dose groups, with plans to add 14 more patients once the optimal dose is determined. The trial is expected to complete in 18-24 months.
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.
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