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Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) is a clinical stage pharmaceutical company pioneering innovative therapies aimed at curing cancers. Founded in 2012 by faculty members from Georgetown University Medical Center, Shuttle Pharma focuses on developing radiation sensitizers to enhance the efficacy of radiation therapy (RT). The company’s mission is to improve cancer treatment outcomes, prolong patient survival, and elevate the quality of life for those undergoing therapy.
Shuttle Pharma's flagship product, Ropidoxuridine (IPdR), is a leading candidate designed to be used in combination with RT for treating glioblastoma, a lethal brain tumor currently without a cure. The company has received positive feedback from the U.S. Food and Drug Administration (FDA), including a 'Safe to Proceed' letter, enabling the commencement of Phase II clinical trials. The FDA's guidance has paved the way for Shuttle Pharma to develop Ropidoxuridine further as a radiation sensitizer.
In addition to Ropidoxuridine, Shuttle Pharma is advancing its predictive biomarker program for prostate cancer. This initiative includes licensing intellectual property from Georgetown University to develop diagnostic blood tests. These tests aim to predict the success or failure of RT in prostate cancer patients, thereby informing treatment decisions and improving patient management.
Shuttle Pharma operates with a strong collaborative ethos, partnering with academic institutions and leveraging grant funding from entities like the National Institutes of Health (NIH). The company’s research also extends to histone deacetylase (HDAC) inhibitors, such as its lead HDAC6 inhibitor candidate, SP-2-225, which aims to prevent tumor relapse and enhance antitumor immune responses.
Financially, Shuttle Pharma is actively involved in capital raising initiatives to support its ambitious research and development goals. A recent Rights Offering aims to raise up to $4.5 million, supplementing the company’s resources to advance its clinical trials and diagnostic programs.
Overall, Shuttle Pharmaceuticals Holdings, Inc. is at the forefront of developing groundbreaking therapies that could revolutionize cancer treatment by making radiation therapy more effective and less toxic.
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.
Shuttle Pharmaceuticals has appointed Timothy Lorber as the new Chief Financial Officer (CFO), replacing Michael Vander Hoek, who will focus on his role as Vice President, Regulatory. Lorber, a CPA with over 40 years of experience, including significant roles at Legg Mason and Freddie Mac, brings expertise in valuations, M&A transactions, and SEC reporting. He will start as a part-time CFO and transition to full-time by September 10, 2024. Vander Hoek, who has been handling dual roles for four years, will now concentrate on regulatory matters, especially with the upcoming Phase 2 clinical trial.
Shuttle Pharmaceuticals (Nasdaq: SHPH) will participate in the Lytham Partners Spring 2024 Investor Conference on May 30, 2024. CEO Dr. Anatoly Dritschilo will present updates on the Phase 2 clinical trial of Ropidoxuridine for glioblastoma and the development of predictive biomarkers for prostate cancer by Shuttle Diagnostics, Inc. The webcast presentation will be at 11:00 am ET, with virtual one-on-one meetings available throughout the event. The webcast can be accessed via the conference homepage or directly. Shuttle Pharmaceuticals focuses on enhancing radiation therapy outcomes for cancer patients.
Shuttle Pharmaceuticals Holdings (Nasdaq: SHPH) provided a corporate update for Q1 2024. Highlights include FDA and IRB approvals for a Phase 2 clinical trial of Ropidoxuridine for glioblastoma. The company is finalizing site enrollments with 'first patient, first dose' expected in Q2 2024. Shuttle Pharma also created Shuttle Diagnostics to develop diagnostic tests for prostate cancer, and entered exclusive licensing agreements with Georgetown University for predictive biomarkers. The cash balance as of March 31, 2024, was $4.2 million. Recent presentations were made at the Planet MicroCap Showcase and other investor conferences.
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