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GAITHERSBURG, Md. - Shuttle Pharmaceuticals Holdings, Inc. (NASDAQ:SHPH), a pharmaceutical company specializing in cancer treatment, has announced significant progress in its Phase 2 clinical trial for Ropidoxuridine, a drug intended for patients with glioblastoma. The trial has reached nearly 50% enrollment, with reports indicating the drug is well-tolerated, exhibiting toxicity levels no greater than 2 on a 1-5 scale. According to InvestingPro data, the micro-cap company, currently valued at $1.61 million, maintains a healthy balance sheet with more cash than debt, despite not yet achieving profitability.
The company, which focuses on enhancing outcomes for cancer patients undergoing radiation therapy, has begun analyzing pharmacokinetic and pharmacodynamic samples to determine the optimal relationship between dosage and response. With 84% of enrolled patients having completed all seven cycles of treatment, Shuttle Pharma aims to finalize enrollment later this year, with data follow-up and readout expected in 2026. The company’s stock, currently trading at $0.27, has faced significant headwinds, with InvestingPro analysis showing a 70% decline year-to-date. Subscribers can access 8 additional ProTips and comprehensive financial metrics to better understand the investment outlook.
Ropidoxuridine, Shuttle Pharma’s lead candidate, is designed to be used in conjunction with radiation therapy to treat glioblastoma, a particularly aggressive brain tumor. The drug has already received Orphan Drug Designation from the FDA, which could grant the company exclusive marketing rights upon approval.
The current trial design involves 40 patients randomized into two groups receiving different dosages of Ropidoxuridine, with the goal of identifying an optimal dose. Following this, an additional 14 patients will be enrolled at the determined optimal dose to demonstrate increased survival against historical controls.
The trial is being conducted across several notable medical centers, including Georgetown University Medical Center and Miami Cancer Institute. The advancement of radiation sensitizers like Ropidoxuridine is seen as critical in the effort to improve cure rates, prolong survival, and enhance the quality of life for cancer patients.
Shuttle Pharma’s Chairman and Chief Scientific Officer, Anatoly Dritschilo, M.D., expressed optimism about the trial’s progress and the potential impact Ropidoxuridine could have on the standard of care for glioblastoma patients.
In the United States, approximately 800,000 cancer patients receive radiation therapy annually, with about half treated for curative purposes. The market for radiation sensitizers is thus significant, particularly as this patient group is expected to grow over the next five years. Despite the substantial market opportunity, InvestingPro’s Financial Health Score indicates current challenges, with the company’s overall financial health rated as WEAK. Investors seeking deeper insights into biotechnology investment opportunities can access comprehensive analysis and screening tools through InvestingPro’s advanced stock screener.
This information is based on a press release statement from Shuttle Pharmaceuticals Holdings, Inc.
In other recent news, Shuttle Pharmaceuticals Holdings, Inc. has announced a provisional patent application for a prostate cancer therapy, marking a significant advancement in its diagnostic and therapeutic programs. The innovation involves a PSMA-targeted PARP inhibitor designed to enhance the effects of radiation and chemotherapy on prostate cancer cells. Additionally, the company has priced a public offering of 19,166,667 shares at $0.30 each, aiming to raise approximately $5.75 million to fund Phase II clinical trials and other corporate purposes. Shuttle Pharmaceuticals has also entered into a consulting agreement with Bowery Consulting Group Inc., which will advise on business strategies, market messaging, and capital raising tactics. Furthermore, the company has appointed Christopher Cooper as interim Co-Chief Executive Officer alongside Dr. Anatoly Dritschilo, to strengthen its business operations and capital markets presence. In another strategic move, Shuttle Pharmaceuticals amended its agreement with Alto Opportunity Master Fund, SPC, simplifying its capital structure by waiving certain rights previously held by Alto Fund. These developments reflect Shuttle Pharmaceuticals’ ongoing efforts to enhance its financial and operational strategies.
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