Shuttle Pharma Shares Exciting Progress in Clinical Trials
Exciting Developments from Shuttle Pharmaceuticals
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) is making significant strides in improving cancer treatment, particularly for patients undergoing radiation therapy. The company recently announced a corporate update following the filing of its Quarterly Report for the second quarter of the fiscal year. This update brings exciting news for the clinical trials of their lead candidate, Ropidoxuridine.
Highlights of Recent Achievements
Shuttle Pharma has opened enrollment for patients in its Phase 2 clinical trial for Ropidoxuridine, aimed specifically at those battling glioblastoma. This aggressive brain cancer currently has no known cure, and Ropidoxuridine is designed to enhance the effectiveness of radiation therapy used in its treatment. With two sites already prepared to initiate the trial, Shuttle Pharma plans to expand to a total of six sites, enhancing accessibility for potential participants.
Clinical Trial Progress
The Phase 2 clinical trial is poised to include 40 patients, split into two dosing groups. This initial phase focuses on determining the optimal dosage of Ropidoxuridine, with the goal of boosting survival rates compared to historical data. The urgency of this trial is evident, as patients suffering from IDH wild-type, methylation negative glioblastoma often face bleak survival expectations of less than a year post-diagnosis.
Leadership Insights
Dr. Anatoly Dritschilo, Chairman and CEO of Shuttle Pharma, highlighted the meticulous preparation that led to this critical milestone. He explained that the journey to patient enrollment involved essential steps, including the development of the drug's active pharmaceutical ingredient (API) and its formulation. The commitment of the Shuttle Pharma team to execute these phases has been instrumental in achieving this advancement in their mission to improve outcomes for cancer patients.
Regulatory Milestones and Market Position
In addition to the trial progress, Shuttle Pharma has secured Orphan Drug Designation from the FDA for Ropidoxuridine. This designation could offer them potential marketing exclusivity upon the drug's FDA approval, potentially reinforcing their market position and driving further research and development opportunities.
Recent Nasdaq Compliance Updates
After facing compliance challenges linked to a re-audit of previous financial statements, Shuttle Pharma has addressed these issues diligently. They successfully filed their Quarterly Report for the second quarter and regained compliance with Nasdaq’s regulations, thus ensuring the continuation of their operations and stability in the market.
About Shuttle Pharmaceuticals
Founded in 2012 by experts from Georgetown University Medical Center, Shuttle Pharmaceuticals is dedicated to enhancing the effectiveness of radiation therapy for cancer patients. By developing innovative sensitizers like Ropidoxuridine, Shuttle Pharma aims to increase survival rates and improve quality of life for patients undergoing treatment. Their mission is clear: to transform cancer therapy into a more effective and compassionate protocol.
Frequently Asked Questions
What is Ropidoxuridine?
Ropidoxuridine is Shuttle Pharma's lead candidate designed to increase the efficacy of radiation therapy in treating glioblastoma, a type of aggressive brain cancer.
How many patients will be involved in the clinical trial?
The Phase 2 clinical trial will initially involve 40 patients, who will be randomized into two dosage groups to determine the optimal dose.
What is the duration of the clinical trial?
The clinical trial is expected to take between 18 to 24 months, with findings crucial for understanding the drug's effectiveness.
What does the Orphan Drug Designation mean for Shuttle Pharma?
Receiving Orphan Drug Designation from the FDA offers potential marketing exclusivity for Ropidoxuridine upon approval, which could enhance Shuttle Pharma's ability to bring the drug to market.
What recent compliance issues did Shuttle Pharma face?
Shuttle Pharma encountered compliance challenges due to a re-audit of past financial statements but has successfully addressed these issues and regained compliance with Nasdaq.
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