GAITHERSBURG, Md. - Shuttle Pharmaceuticals Holdings, Inc. (NASDAQ:SHPH), a pharmaceutical company specializing in cancer treatment enhancements, has announced the expansion of its Phase 2 clinical trial for glioblastoma therapy. The trial will now include two additional sites, with four out of the planned six locations ready to enroll patients.
The trial focuses on the drug Ropidoxuridine, intended to improve survival rates for patients with IDH wild-type, methylation negative glioblastoma, an aggressive brain tumor. The company has initiated site visits and is prepared to begin patient treatment at the UVA Cancer Center, John Theurer Cancer Center, Allegheny Health Network (LON:NETW) Cancer Institute, and Miami Cancer Institute.
Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D., expressed satisfaction with the progress, emphasizing the significance of the selected trial sites in potentially accelerating patient enrollment. The trial aims to establish an optimal dosage of Ropidoxuridine, with an initial 40 patients split into two groups receiving different doses. An additional 14 patients will later be added to the optimal dose group to enhance the statistical significance of the survival endpoint.
Ropidoxuridine has been granted Orphan Drug Designation by the FDA, which may provide marketing exclusivity upon approval. The trial is expected to last 18 to 24 months, targeting a patient population for whom radiation therapy is the current standard of care. With over 800,000 patients in the US undergoing radiation therapy annually, the potential market for radiation sensitizers like Ropidoxuridine is substantial, especially among the 400,000 treated with curative intent.
Shuttle Pharmaceuticals, founded by Georgetown University Medical Center faculty in 2012, is dedicated to improving radiation therapy outcomes for cancer patients. The company's mission is to enhance cancer cure rates and quality of life by developing therapies that maximize radiation effectiveness while minimizing side effects.
This expansion of the Phase 2 clinical trial marks a step forward in Shuttle Pharma's efforts to address the unmet needs of glioblastoma patients. The trial's progress and further details can be tracked through the clinicaltrials.gov database, under study number NCT06359379.
The information reported is based on a press release statement from Shuttle Pharmaceuticals Holdings, Inc.
In other recent news, Shuttle Pharmaceuticals has been grappling with Nasdaq delisting over an equity shortfall, falling short of the $2,500,000 threshold outlined in Nasdaq Listing Rule 5550(b)(1). The company is actively exploring options to regain compliance, with a 45-day window to propose a plan. A significant development in their pharmaceutical endeavors, Shuttle Pharmaceuticals secured a patent for selective histone deacetylase (HDAC) inhibitors aimed at enhancing cancer treatments. They have also published promising research on a new compound, SP-1-303, showing potential in inhibiting the growth of estrogen receptor-positive breast cancer cells.
In the financial realm, they have regained compliance with Nasdaq's Minimum Bid Price Rule and entered into an Amendment Agreement with Alto Opportunity Master Fund, which includes a $600,000 payment as collateral on an outstanding $1.2 million note. The company's stockholders approved a one-for-eight reverse stock split and plans to restate its financial statements for 2022 and the first quarter of 2024 due to identified accounting errors. This restatement will increase the net loss attributable to common stockholders from $3.1 million to $3.7 million for 2022. Lastly, Shuttle Pharmaceuticals announced executive team changes, with the appointment of Timothy Lorber as the new Chief Financial Officer, while Michael Vander Hoek, the current CFO, will focus on his role as Vice President of Regulatory. These are the recent developments for Shuttle Pharmaceuticals.
InvestingPro Insights
As Shuttle Pharmaceuticals Holdings, Inc. (NASDAQ:SHPH) advances its Phase 2 clinical trial for glioblastoma therapy, potential investors and stakeholders are assessing the company's financial health and stock performance. According to InvestingPro, SHPH holds more cash than debt on its balance sheet, which could provide a degree of financial stability as it funds its ongoing research and development activities. However, it's important to note that the company is quickly burning through cash, a situation that warrants close monitoring given the significant costs associated with clinical trials.
From a stock performance perspective, SHPH has experienced a significant return over the last week, with an 18.06% increase in price total return. This could indicate investor optimism regarding the recent developments in the company's clinical trials. Nonetheless, the stock has faced challenges over longer periods, with a price total return of -70.2% over the last year. The current market capitalization stands at a modest 3.79M USD, reflecting the company's small size and the high-risk nature of biotech investing.
For those interested in diving deeper into Shuttle Pharma's financials and stock performance, InvestingPro offers additional insights with over 10 InvestingPro Tips available for SHPH, including analysis on profitability, valuation, and dividend policies. To explore these valuable tips, visit: https://www.investing.com/pro/SHPH.
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