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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 Holdings (Nasdaq: SHPH) has successfully closed its previously announced underwritten public offering, raising $5.75 million in gross proceeds through the sale of 19,166,667 shares of common stock at $0.30 per share.
The company plans to utilize the net proceeds to fund its Phase II clinical trial for its lead product candidate, marketing and advertising services, and working capital. The offering was conducted on a firm commitment basis with WestPark Capital acting as the Sole Book-Runner.
Shuttle Pharma, founded in 2012 by Georgetown University Medical Center faculty members, focuses on developing radiation sensitizers to improve outcomes for cancer patients treated with radiation therapy (RT). Their mission aims to enhance cancer cure rates while limiting radiation side effects when used as primary treatment or in combination with other therapies.
Shuttle Pharmaceuticals Holdings (Nasdaq: SHPH) has announced the pricing of a $5.75 million underwritten public offering, consisting of 19,166,667 shares of common stock at $0.30 per share. The offering, expected to close on March 13, 2025, is being conducted on a firm commitment basis with WestPark Capital as the Sole Book-Runner.
The net proceeds will fund three key initiatives:
- Phase II clinical trial for lead product candidate
- Marketing and advertising services
- Working capital and general corporate purposes
Shuttle Pharma, founded in 2012 by Georgetown University Medical Center faculty, focuses on improving outcomes for cancer patients treated with radiation therapy by developing radiation sensitizers to enhance treatment effectiveness while limiting side effects.
Shuttle Pharmaceuticals Holdings (Nasdaq: SHPH) has appointed Christopher Cooper as interim Co-Chief Executive Officer to enhance the company's capital markets and business capabilities. Dr. Anatoly Dritschilo will continue as Chairman of the Board and Co-CEO, focusing on scientific and clinical trial activities.
Cooper brings over 27 years of management and finance experience across various industries. He currently serves as President, CEO, and Founder of First Towers & Fiber Corp since 2017. Previously, he was President and CEO of Aroway Energy (2010-2017) and worked as a Corporate Consultant (1998-2010), raising over $100 million in debt and equity for clients.
The new Co-CEO structure aims to enable parallel execution of R&D, regulatory, and general business operations, with a focus on advancing the company's Phase 2 clinical trial of Ropidoxuridine for glioblastoma treatment and the development of their Diagnostics subsidiary.
Shuttle Pharmaceuticals (NASDAQ: SHPH) has provided a corporate update for 2024, highlighting significant progress in its cancer treatment programs. The company reported 40% enrollment completion in the Phase 2 clinical trial of Ropidoxuridine for glioblastoma treatment, with 16 out of 40 initial patients enrolled and 8 patients completing all seven cycles.
The trial is being conducted at several prestigious cancer centers including Georgetown University Medical Center and UNC Medical Center. Additionally, Shuttle Pharma's Diagnostics subsidiary entered a research agreement with UCSF to develop a PSMA ligand for cancer diagnosis and therapy.
The company secured additional funding, including a $237,500 investment from CEO Dr. Anatoly Dritschilo. The company's focus remains on developing radiation sensitizers to enhance cancer treatment outcomes and advancing diagnostic tools for predicting radiation therapy success, particularly in prostate cancer treatment.
Shuttle Pharmaceuticals Holdings (SHPH) has reached 25% enrollment in the initial randomized portion of its Phase 2 Clinical Trial of Ropidoxuridine for glioblastoma treatment. The trial design involves randomizing 40 patients into two dose levels: 1,200 mg/day and 960 mg/day, followed by enrolling 14 additional patients at the optimal dose.
The trial focuses on patients with IDH wild-type, methylation negative glioblastoma, where currently less than half survive beyond 12 months after diagnosis. The study is being conducted at six nationally recognized cancer centers. Ropidoxuridine, Shuttle Pharma's lead radiation sensitizer candidate, has received FDA Orphan Drug Designation.
The company aims to serve an estimated 400,000 US patients treated with radiation therapy for curative purposes annually, with this market expected to grow by 22% over the next five years.
Shuttle Pharmaceuticals Holdings (Nasdaq: SHPH) has announced its participation in the Lytham Partners 2025 Investor Healthcare Summit on January 13, 2025. CEO Anatoly Dritschilo, M.D., will lead a webcasted fireside chat at 3:30 p.m. Eastern time.
During the virtual event, Dr. Dritschilo will outline the company's 2025 plans, focusing on their Phase 2 Clinical Trial of Ropidoxuridine for glioblastoma treatment. The trial is currently enrolling patients at six nationally recognized cancer centers, targeting IDH wild-type, methylation negative glioblastoma.
The discussion will also cover developments in the Shuttle Diagnostics subsidiary, particularly the PC-RAD test for predicting radiation therapy outcomes in prostate cancer patients, and their work on a PSMA ligand as a potential theranostic molecule.
Shuttle Pharmaceuticals Holdings (SHPH) has entered into a sponsored research agreement with the University of California, San Francisco (UCSF) to advance pre-clinical development of its PSMA-B ligand for prostate cancer diagnosis and treatment. The research will focus on developing the molecule as a potential diagnostic and therapeutic (theranostic) tool.
UCSF researchers, led by Dr. Robert Flavell, will develop radiosynthetic methods for producing [18F]FPA-ACUPA probe, investigate cellular binding properties, and explore diagnostic potential across various prostate cancer phenotypes. The global PSMA PET Imaging Market reached $1.5 billion in 2022 and is projected to reach $2.0 billion by 2030.
Shuttle Pharmaceuticals Holdings (SHPH) announced the enrollment and dosing of its first patient at UVA Cancer Center in its Phase 2 Clinical Trial of Ropidoxuridine for glioblastoma treatment. The trial, conducted across six cancer centers, will initially include 40 patients randomized into two doses (20 @ 1,200 mg/day and 20 @ 960 mg/day), followed by an additional 14 patients at the optimal dose. The study targets IDH wild-type, methylation negative glioblastoma patients, who currently have treatment options with radiation therapy. The company previously received FDA Orphan Drug Designation for Ropidoxuridine.
Shuttle Pharmaceuticals Holdings (NASDAQ: SHPH) provided a Q3 2024 corporate update highlighting key developments. The company successfully dosed the first three patients in its Phase 2 clinical trial of Ropidoxuridine for glioblastoma treatment and finalized agreements with all six planned enrollment sites. Financial updates include paying off a $4.3M Senior Secured Convertible Note, completing a $4.5M public offering, and closing a $790,000 convertible note offering. The company reported a cash balance of $4.1M as of October 31, 2024.
The Phase 2 trial will enroll 40 patients initially, randomized into two dosage 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 Holdings (Nasdaq: SHPH) has announced pricing of a $4.5 million public offering priced at-the-market. The offering includes up to 2,950,820 shares of common stock (or pre-funded warrants) and warrants at $1.525 per share and accompanying warrant. The warrants, exercisable at $1.40 per share, will expire in five years. Net proceeds will fund IND-enabling and Phase I/II clinical trials, including $2.3 million payment to Theradex Systems for Phase II trials of Ropidoxuridine. The offering is expected to close around October 31, 2024.
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