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QUANTUM LEAP NEXT GENERATION CANCER RADIATION TREATMENT
Shuttle Pharmaceuticals’ Ropidoxuridine Could Substantially Increase Demand for Improved and Cost-Effective Cancer Radiation Treatments
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National Cancer Institute supported clinical trials found iododeoxyuridine (IUdR) is a potent radiation sensitizer that could be a game changer for cancer patients undergoing radiation therapy.
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Unfortunately, iododeoxyuridine is troubled by dose-limiting systemic toxicities and the need for prolonged continuous IV infusion that exposes patients to excessive infection risk.
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Shuttle developed orally delivered Ropidoxuridine (IPdR) that replaces iododeoxyuridine and solves many problematic issues. Shuttle Pharmaceuticals is beginning Phase 2 clinical trial.
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Management is highly experienced. A recent filing shows that the CEO, Dr. Anatoly Dritschilo stepped up with is own personal financing as the company filed an S1 suggesting a new round of finance to fund trials and operations.
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Successful clinical trials of Ropidoxuridine have the potential to substantially increase demand for an already large radiation therapy market.
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Shuttle Pharmaceuticals Holdings, Inc. has a market cap close to $4 million and a share price of $1.28 as of the close of October 24, 2024.
Radiation therapy is an $8 billion market commonly used to treat cancer, however its’ dosage is limited by the harmful effects it can have on normal healthy cells that are adjacent to the targeted cancerous cells. Limiting the dosage of radiation limits the efficacy of this treatment.
Investment thesis:
A safe drug that would make cancer cells more sensitive and more responsive to radiation therapy would likely be in substantial demand as it could dramatically improve the efficacy and increase the usage of radiation treatment.
Findings in Phase 2 clinical trial of radiation sensitizer iododeoxyuridine
The Phase 2 clinical trial found that iododeoxyuridine (IUdR), is a powerful tool to add to radiation therapy because it makes cancer cells more sensitive to the treatment of radiation.
Iododeoxyuridine (IUdR) is a potent radiosensitizer, however, its clinical utility is limited by dose limiting systemic toxicities and the need for prolonged continuous infusion.
Shuttle Pharmaceutical Holdings, Inc. (SHPH: NASD) Ropidoxuridine is a safer and more effective way to administer radiation therapy
Ropidoxuridine is a prodrug (equivalent) of IUdR that compared to IUdR, is easier to administer and less toxic with a more favorable therapeutic index in preclinical studies.
Safety of Ropidoxuridine was demonstrated in a phase 1 study from Shuttle's SBIR (Small Business Innovation Research Contract) acknowledged on page 6041. The phase 1 clinical trial was conducted by the Brown University Oncology Group at Lifespan Rhode Island Hospital under a contract with Shuttle.
This article shows the safety of IPdR at a maximum tolerated dose of 1200 mg (one of the two dosages in our phase 2 trial). At 1800 mg there was toxicity with dehydration and diarrhea - pg 6038 copied below. Diarrhea is the most common side effect with 1200 mg or less.
The study concluded that administration of IPdR PO QD x 28 days with RT is feasible and tolerable at doses that produce plasma IUdR levels ≥1μM/L. These results support the investigation of IPdR + RT in phase II studies.
In terms of efficacy, Ropidoxuridine demonstrated an increase in median survival by an impressive 50% or more in this phase 1 clinical trial.
Shuttle is Advancing Ropidoxuridine in a phase 2 clinical trial to overcome the barriers of Iododeoxyuridine
Shuttle Pharmaceuticals recently announced, “Shuttle Pharma Expands Clinical Trial Site Enrollment for Phase 2 of Ropidoxuridine for Treatment of Patients with Glioblastoma.” Ropidoxuridine (IPdR) is Shuttle Pharma's lead candidate radiation sensitizer for use in combination with RT to treat brain tumors (glioblastoma), a deadly malignancy of the brain with no known cure. Shuttle received Orphan Drug Designation from the FDA, providing potential marketing exclusivity and potentially faster track upon first FDA approval for the disease.
The Phase 2 clinical trial will enroll patients with the most aggressive brain tumors out there – IDH wild-type, methylation negative glioblastoma. Presently, radiation is the only approved standard of care for this particular group of patients, with more than half of the patients surviving for less than 12 months after diagnosis. Shuttle Pharma’s Phase 2 clinical trial will consist initially of 40 patients randomized into two different doses (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose. Once the Company determines the optimal dose, it will then add an additional 14 patients on the optimal dosage allowing for the achievement of statistical significance with the end point being that of survival as compared to historical controls. The Company expects the trial to be completed over a period of 18 to 24 months.
An estimated 800,000 patients in the US are treated with radiation therapy for their cancers yearly. According to the American Cancer Society and the American Society of Radiation Oncologists, about 50% are treated for curative purposes and the balance for therapeutic care. The market opportunity for radiation sensitizers lies with the 400,000 patients treated for curative purposes, with this number expected to grow by more than 22% over the next five years.
Improving care while reducing costs
Cost effectiveness research studies demonstrate the favorable impact of improving the quality of care for Shuttle’s patient group while reducing healthcare costs. See “Treatment of unmethylated MGMT-promoter recurrent glioblastoma with cancer stem cell assay-guided chemotherapy and the impact on patients’ healthcare costs | Neuro-Oncology Advances | Oxford Academic.”
Management
Management is always a key factor to consider in any investment decision. A review of Shuttle’s management reveals a well-seasoned team with impressive experience in oncology and radiation therapy as well as regulatory affairs and medical research.
Financials
Shuttle Pharmaceutical Holdings, Inc. stands out from several early-stage biotech companies in that their current ratio is healthy, their burn rate is very well managed, and aside from their $826,000 convertible debt, their debt is unusually small. Readers should note that the CEO, Dr. Anatoly Dritschilo recently stepped up and loaned the company $237,000.
Risk factors
There are always risk factors that investors should consider and there is an extensive list of potential risk factors in a recent filing. I believe the 2 main risk factors that Shuttle and every other biotech share in common are, running out of capital to fund trials and operations, and trial failure. A more thorough list of risk factors are presented on Pages 9 and 10 of a recent S1 filing.
Competition
Competition in biotech always remains fierce, however, there is very little information about companies successfully pursuing the area of radiation sensitizers. Readers are encouraged to research further to learn more about any other companies doing similar work. I have conducted a series of queries and have not been able to find any other efforts with results as promising as Shuttle’s.
Potential Combination Trials
The combination of sensitizer and Radiation Therapy with other treatments, such as immunotherapy is speculative, but possible. Remember, RT is standard of care for IDH wild-type, methylation negative GBM, so we are adding the sensitizer to make the RT more effective. The addition of immunotherapy after the standard course of treatment is a little more speculative but should be considered as a "next-generation" approach to be tested.
Northwest Biotherapeutics (NWBO: OTC) completed a successful phase 3 clinical trial for their DC Vax immunotherapy for GBM patients. It appears that Ropidoxuridine could be a good fit for a combination trial with DC Vax and holds the potential to increase efficacies even further. MRK:NYSE Keytruda and $BMY:NYSE Opdivo are 2 leading cancer treatment drugs that are also potential candidates for combination trials.
Conclusion
Shuttle Pharmaceutical Holdings has assembled a highly experienced team that continues to deliver positive results. Management is advancing their lead drug, Ropidoxuridine, that promises to bring safe and more effective cancer treatment to millions in need. Shuttle has built a solid base for further clinical trials that can lead to widespread use of a badly needed and radically advanced radiotherapy to treat a broad spectrum of cancers.
If Shuttle is successful, the low closing share price of $1.28 per share as of October 24, 2024, could present an outstanding investment opportunity in a very exciting potential advancement to treat cancer.
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