CLINICAL TRIALS PROFILE FOR SODIUM PHOSPHATE P-32

505(b)(2) Clinical Trials for Sodium Phosphate P-32

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01889173 ↗	Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults	Completed	Tonix Pharmaceuticals, Inc.	Phase 1	2013-06-01	Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of 3 different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8 mg SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and TNX-102-C with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).
OTC	NCT03707795 ↗	Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study	Completed	Edward Kasaraskis	Early Phase 1	2017-08-21	By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.
OTC	NCT03707795 ↗	Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study	Completed	University of Kentucky	Early Phase 1	2017-08-21	By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.
OTC	NCT03774498 ↗	Effect of Different Over-the-counter Toothpastes on Enamel Remineralization	Unknown status	Cairo University	N/A	2019-01-01	This study will be conducted to compare between recent over-the-counter toothpaste (Novamin & Fluoride) and regular over-the-counter toothpaste (Sodium Fluoride) in remineralization potential, so as to be able to know which of the toothpastes will have a better remineralization potential on demineralized enamel.

All Clinical Trials for Sodium Phosphate P-32

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004767 ↗	Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	Completed	Johns Hopkins University	Phase 2	1985-01-01	OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00004767 ↗	Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	Completed	National Center for Research Resources (NCRR)	Phase 2	1985-01-01	OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00074165 ↗	Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen	Terminated	National Cancer Institute (NCI)	Phase 2	2003-01-01	RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.
NCT00074165 ↗	Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen	Terminated	OHSU Knight Cancer Institute	Phase 2	2003-01-01	RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.
NCT00075387 ↗	Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2003-03-07	This randomized phase II trial studies how well giving combination chemotherapy with or without sodium thiosulfate works in preventing low platelet count while treating patients with malignant brain tumors. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sodium thiosulfate may prevent low platelet counts in patients receiving chemotherapy. It is not yet known whether combination chemotherapy is more effective with or without sodium thiosulfate in preventing low platelet count during treatment for brain tumors.
NCT00075387 ↗	Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors	Active, not recruiting	Oregon Health and Science University	Phase 2	2003-03-07	This randomized phase II trial studies how well giving combination chemotherapy with or without sodium thiosulfate works in preventing low platelet count while treating patients with malignant brain tumors. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sodium thiosulfate may prevent low platelet counts in patients receiving chemotherapy. It is not yet known whether combination chemotherapy is more effective with or without sodium thiosulfate in preventing low platelet count during treatment for brain tumors.

Clinical Trial Conditions for Sodium Phosphate P-32

Condition Name

Condition Name for Sodium Phosphate P-32
Intervention	Trials
Colonoscopy	10
Healthy	7
Early Childhood Caries	4
Dry Eye	3

Condition MeSH

Condition MeSH for Sodium Phosphate P-32
Intervention	Trials
Syndrome	7
Dental Caries	6
Renal Insufficiency, Chronic	6
Kidney Diseases	6

Clinical Trial Locations for Sodium Phosphate P-32

Trials by Country

Trials by Country for Sodium Phosphate P-32
Location	Trials
United States	172
Germany	12
India	9
China	9
Israel	7

Trials by US State

Trials by US State for Sodium Phosphate P-32
Location	Trials
New York	14
California	12
Texas	12
Connecticut	8
North Carolina	8

Clinical Trial Progress for Sodium Phosphate P-32

Clinical Trial Phase

Clinical Trial Phase for Sodium Phosphate P-32
Clinical Trial Phase	Trials
Phase 4	41
Phase 3	25
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for Sodium Phosphate P-32
Clinical Trial Phase	Trials
Completed	90
Recruiting	23
Unknown status	20

Clinical Trial Sponsors for Sodium Phosphate P-32

Sponsor Name

Sponsor Name for Sodium Phosphate P-32
Sponsor	Trials
National Cancer Institute (NCI)	9
OHSU Knight Cancer Institute	5
University of California, San Francisco	4

Sponsor Type

Sponsor Type for Sodium Phosphate P-32
Sponsor	Trials
Other	186
Industry	50
NIH	20

Sodium Phosphate P-32: Clinical Trials, Market Analysis, and Projections

Introduction to Sodium Phosphate P-32

Sodium Phosphate P-32, or Phosphorus-32 (P-32), is a radioactive isotope of phosphorus that has been utilized in various medical and therapeutic applications. This radiopharmaceutical is particularly notable for its use in treating certain hematological conditions and palliating bone pain.

Clinical Applications of Sodium Phosphate P-32

Treatment of Myeloproliferative Neoplasms (MPNs)

P-32 is used to treat MPNs, such as polycythemia vera (PV), especially in patients who are unresponsive or intolerant to other therapies like hydroxyurea, interferon, or ruxolitinib. It is administered intravenously and accumulates in dividing cells, delivering radiation to cancerous tissues in the bone marrow, thereby killing these cells by interfering with their DNA[1].

Palliation of Bone Pain

P-32 is also used to alleviate bone pain in patients with prostate and breast cancers who have bone metastases and are no longer responsive to conventional analgesics. It delivers beta electron radiation directly to bone lesions, providing pain relief in approximately half of the patients. Pain relief typically begins within two weeks and can last for an average of five months[5].

Intratumoral Injection for Solid Tumors

In clinical trials, P-32 chromic phosphate has been injected intratumorally to treat refractory solid tumors or solitary metastases. This method has shown significant tumor regression and improved survival rates, with a response rate of 71% and a median survival of 13 months[3].

Clinical Trials and Efficacy

Efficacy in MPNs

P-32 has been shown to induce long-term remissions in some patients with MPNs, although its use is generally reserved for older patients due to the risk of leukemic transformation[1].

Intratumoral Injection Trials

A Phase II study involving intratumoral injection of P-32 chromic phosphate demonstrated remarkable tumor regression, with 41% of patients achieving complete remission and 29% achieving partial remission. The treatment was well-tolerated, with minimal side effects[3].

Bone Pain Palliation

Clinical trials have consistently shown that P-32 sodium phosphate is effective in palliating bone pain, with around half of the patients experiencing meaningful pain relief. The treatment is particularly valued for its cost-effectiveness and accessibility in regions with limited advanced radionuclide production facilities[5].

Side Effects and Safety Considerations

Common Side Effects

The use of P-32 is associated with several side effects, including decreased blood counts, diarrhea, fever, and nausea or vomiting. Higher doses above 12 mCi are associated with an increased risk of myelosuppression[1][5].

Specific Considerations for MPNs

In the treatment of MPNs, the risk of leukemic transformation is a significant concern, which is why P-32 is typically reserved for older patients or those with limited therapeutic options[1].

Market Analysis and Projections

Global Sodium Phosphate Market

The global sodium phosphate market, which includes various forms of sodium phosphate, was valued at USD 7.03 billion in 2023 and is expected to grow at a CAGR of 5.67% from 2024 to 2030, reaching nearly USD 10.34 billion. The market is driven by increasing demand in the food and beverage sector, as well as in fertilizers and detergents[2].

Specific Market for P-32

While the broader sodium phosphate market is significant, the specific market for P-32 is more niche, focused on its therapeutic applications. The demand for P-32 is influenced by its efficacy in treating specific conditions and its cost-effectiveness, particularly in low- to middle-income regions where access to more advanced radiopharmaceuticals may be limited[5].

Geographical Distribution

The Asia Pacific region leads the demand for sodium phosphate, including P-32, due to the growing demand for processed foods and the increasing population in countries like India and China. North America and Europe are also expected to see significant growth in the market[2].

Economic and Accessibility Factors

P-32 sodium phosphate stands out as an economical and relatively easily accessible treatment option. Its production processes are well-known, and the facilities required to produce or store P-32 are more widespread than those needed for newer, shorter half-life isotopes. This makes it a preferred choice in regions with limited healthcare infrastructure[5].

Conclusion

Sodium Phosphate P-32 remains a valuable tool in the treatment of certain hematological conditions and in the palliation of bone pain. Its efficacy, cost-effectiveness, and accessibility make it an important option in both developed and developing regions.

Key Takeaways

• Therapeutic Applications: P-32 is used to treat MPNs, particularly polycythemia vera, and to palliate bone pain in patients with prostate and breast cancers.
• Clinical Trials: Studies have shown significant efficacy in tumor regression and pain relief, with minimal side effects.
• Market Projections: The global sodium phosphate market is expected to grow, with P-32 playing a niche but important role in therapeutic applications.
• Economic Factors: P-32 is an economical and accessible treatment option, especially in low- to middle-income regions.
• Side Effects: Common side effects include decreased blood counts, diarrhea, fever, and nausea or vomiting, with a higher risk of myelosuppression at higher doses.

FAQs

What is Sodium Phosphate P-32 used for?

Sodium Phosphate P-32 is used to treat myeloproliferative neoplasms (MPNs) like polycythemia vera and to palliate bone pain in patients with prostate and breast cancers.

What are the common side effects of P-32 treatment?

Common side effects include decreased blood counts, diarrhea, fever, and nausea or vomiting. Higher doses can increase the risk of myelosuppression.

How effective is P-32 in treating MPNs?

P-32 can induce long-term remissions in some patients with MPNs, although its use is generally reserved for older patients due to the risk of leukemic transformation.

What is the market outlook for Sodium Phosphate P-32?

The global sodium phosphate market is expected to grow, with P-32 playing a niche but important role in therapeutic applications, particularly in regions with limited access to advanced radiopharmaceuticals.

Why is P-32 preferred in some regions?

P-32 is preferred due to its cost-effectiveness and accessibility, as its production processes are well-known and the facilities required are more widespread than those needed for newer isotopes.

Sources

1. Richard T. Silver MD Myeloproliferative Neoplasms Center: Phosphorous-32.
2. Maximize Market Research: Global Sodium Phosphate Market – Global Industry Analysis and Forecast.
3. PubMed: An early phase II study of intratumoral P-32 chromic phosphate.
4. PubMed: Clinical trial: sodium phosphate tablets are preferred and better tolerated.
5. Open MedScience: 32P-Sodium Phosphate in Palliating Bone Pain.

Last updated: 2025-01-01