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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 (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.
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.
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