CLINICAL TRIALS PROFILE FOR MANGANESE CHLORIDE IN PLASTIC CONTAINER

All Clinical Trials for Manganese Chloride In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03989310 ↗	An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic Pancreatic Cancer	Recruiting	Chinese PLA General Hospital	Phase 1/Phase 2	2019-03-01	The outcome of pancreatic cancer is extremely poor. NCCN guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen, but the response rate is unacceptably low. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This one-arm, phase I/II study is designed to assess the safety and efficacy of Manganese primed combined therapy of anti-PD-1 antibody and chemotherapy.
NCT03989336 ↗	An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Relapsed/Refractory Ovarian Cancer	Recruiting	Chinese PLA General Hospital	Phase 1/Phase 2	2019-06-20	Ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer death in women. Platinum chemotherapy has been widely adopted as a standard treatment for advanced ovarian cancer, the response rates in patients with relapsed/refractory ovarian cancer is unacceptably low. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This two-arm, phase I/II study is designed to assess the safety and efficacy of combined therapy of anti-PD-1 antibody and chemotherapy with or without Manganese priming.
NCT03991559 ↗	A Safety Study of the Pan-immunotherapy in Patients With Unresectable/Metastatic Solid Tumors or Lymphomas	Unknown status	Chinese PLA General Hospital	Phase 1	2018-11-01	Identification of T cell inhibitory signals, including PD-1/PD-L1, has prompted the development of a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. However, elimination of cancer by T cells is only one step in the Cancer-Immunity Cycle, which enable providing several therapeutic targets and tailoring of combinations of immune therapies. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This study is a first-in-man, Phase I, 3 + 3 dose escalation study of a combined regimen of Manganese and anti-PD-1 antibody with or without chemotherapies in subjects with unresectable/ metastatic solid tumors or lymphomas. This study is designed to assess the safety, tolerability, pharmacokinetic profile (PK profile), mode of delivery and Recommended Phase 2 Dose (RP2D) of this regimen.
NCT04004234 ↗	A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC	Unknown status	Chinese PLA General Hospital	Phase 1/Phase 2	2019-03-01	Biliary tract cancer (BTC) is a rare heterogeneous collection of malignancies arising within the biliary tract, characterized by innate chemoresistance and abysmal prognosis. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This open-label, phase I/II study is designed to assess the safety and efficacy of Manganese primed combined therapy of anti-PD-1 antibody and gemcitabine/cisplatin chemotherapy.

Clinical Trial Conditions for Manganese Chloride In Plastic Container

Condition Name

Condition Name for Manganese Chloride In Plastic Container
Intervention	Trials
Lymphoma	2
Solid Tumor	2
Biliary Tract Cancer (BTC)	1
Known or Suspected Focal Liver Lesions and Severe Renal Impairment	1

Condition MeSH

Condition MeSH for Manganese Chloride In Plastic Container
Intervention	Trials
Lymphoma	2
Ovarian Neoplasms	1
Carcinoma, Ovarian Epithelial	1
Pancreatic Neoplasms	1

Clinical Trial Locations for Manganese Chloride In Plastic Container

Trials by Country

Trials by Country for Manganese Chloride In Plastic Container
Location	Trials
United States	10
China	5
Turkey	4
Argentina	1
Poland	1

Trials by US State

Trials by US State for Manganese Chloride In Plastic Container
Location	Trials
Wisconsin	1
Washington	1
North Carolina	1
Missouri	1
Minnesota	1

Clinical Trial Progress for Manganese Chloride In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Manganese Chloride In Plastic Container
Clinical Trial Phase	Trials
Phase 3	1
Phase 1/Phase 2	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Manganese Chloride In Plastic Container
Clinical Trial Phase	Trials
Recruiting	4
Unknown status	2

Clinical Trial Sponsors for Manganese Chloride In Plastic Container

Sponsor Name

Sponsor Name for Manganese Chloride In Plastic Container
Sponsor	Trials
Chinese PLA General Hospital	5
Ascelia Pharma AB	1

Sponsor Type

Sponsor Type for Manganese Chloride In Plastic Container
Sponsor	Trials
Other	5
Industry	1

Manganese Chloride in Plastic Containers: Clinical Trials, Market Analysis, and Projections

Introduction

Manganese chloride, particularly in its tetrahydrate form, has been gaining attention for its various applications, including its potential as a radiation protective agent. This article delves into the clinical trials, market analysis, and future projections for manganese chloride, especially when packaged in plastic containers.

Clinical Trials: Manganese Chloride as a Radiation Protective Agent

Recent studies have shown promising results for manganese chloride (MnCl2) as a prophylactic countermeasure against acute radiation syndrome (ARS)[1][4].

• Survival Rates: In animal studies, mice treated with a dose of 13.5 mg/kg of MnCl2 over three days showed a significant increase in survival rates, reaching up to 80% (87% for females and 73% for males), compared to a 51% survival rate for the control group[1][4].
• Hematopoietic Recovery: The treated groups demonstrated a typical hematopoietic response followed by mildly accelerated recovery by day 28. Histologic evaluation of bone marrow sections showed the best return to cellularity at 80% in the group given 13.5 mg/kg of MnCl2 over three days[1][4].
• Neurotoxicity Tests: No significant differences were observed in neurotoxicity tests such as Rota Rod, DigiGait, and Y-maze, indicating minimal neurotoxic effects of MnCl2[1][4].

These findings suggest that manganese chloride could be a safe and effective prophylactic countermeasure against ARS.

Market Analysis: Manganese Chloride Tetrahydrate

Global Market Size and Growth

The global manganese chloride tetrahydrate market is expected to witness significant growth in the coming years. As of 2023, the market size was notable, and it is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2031[2].

• Segment Analysis: The market is segmented based on type, application, and region. The 99% manganese chloride tetrahydrate segment accounted for a significant share of the global market in 2023 and is expected to continue growing[2].
• Key Applications: Manganese chloride tetrahydrate is used in various sectors, including the pharmaceutical, personal care, and consumer goods industries. The nutraceutical segment is expected to expand at a significant CAGR during the forecast period[2].

Key Players and Strategies

Major companies such as American Elements and Merck KGaA are focusing on strengthening their product portfolios and expanding their business in the global market. These companies are investing in technological advancements to produce high-quality chemicals and comply with environmental and safety regulations[2].

Packaging: Plastic Containers for Manganese Chloride

Importance of Packaging

Packaging plays a crucial role in the storage, handling, and administration of manganese chloride, especially in clinical trials. Plastic containers are widely used due to their durability, cost-effectiveness, and ability to preserve the stability and efficacy of the product[5].

• Plastic Container Market: The plastic container market, which includes packaging for pharmaceuticals, is projected to grow from USD 66.16 billion in 2024 to USD 101.60 billion by 2031, at a CAGR of 5.5%[5].
• Advantages of Plastic Containers: Plastic containers offer excellent barriers against moisture, oxygen, and light, making them ideal for preserving the integrity of manganese chloride. Advances in plastic technology are improving recyclability and promoting the use of sustainable materials[5].

Clinical Trial Packaging Market

Market Size and Growth

The clinical trial packaging market is another critical sector that will influence the packaging of manganese chloride. This market is expected to grow from USD 2.95 billion in 2023 to USD 9.12 billion by 2034, at a CAGR of 10.80%[3].

• Key Drivers: The growth is driven by the increasing need for specialized packaging solutions, particularly for personalized and precision medicine. Innovations in packaging design and technology, such as digital adherence monitoring, are also driving the market[3].
• Regional Analysis: North America, particularly the United States, is a leading hub for clinical trials due to its advanced healthcare infrastructure and significant investment in research and development. This region is expected to continue driving the demand for clinical trial packaging solutions[3].

Future Projections

Market Opportunities

The combination of promising clinical trial results for manganese chloride and the growing demand for specialized packaging solutions presents lucrative opportunities for the market.

• Technological Advancements: Continued technological advancements in the production of high-quality manganese chloride and innovative packaging solutions will drive market growth.
• Regulatory Compliance: Adherence to high standards in clinical trial packaging, especially in regions like North America, will ensure safety, compliance, and quality, further boosting the market[2][3].

Challenges and Restraints

Despite the positive outlook, there are challenges to consider:

• Environmental and Safety Regulations: Compliance with environmental and safety regulations will be crucial. Companies must focus on sustainable packaging solutions and ensure minimal environmental impact[2].
• Raw Material Availability: The availability of raw materials and fluctuations in economic conditions could impact production and pricing[2].

Key Takeaways

• Clinical Trials: Manganese chloride shows promising results as a radiation protective agent with high survival rates and minimal neurotoxic effects.
• Market Growth: The global manganese chloride tetrahydrate market and the clinical trial packaging market are expected to grow significantly over the next few years.
• Packaging: Plastic containers are preferred for their durability and ability to preserve product integrity, with a growing focus on sustainable and recyclable materials.
• Technological Advancements: Innovations in packaging design and technology will continue to drive market growth.

FAQs

What are the key applications of manganese chloride tetrahydrate?

Manganese chloride tetrahydrate is used in various sectors, including pharmaceuticals, personal care, and consumer goods. The nutraceutical segment is particularly significant and expected to expand at a high CAGR[2].

How does manganese chloride perform in clinical trials for radiation protection?

Manganese chloride has shown promising results in animal studies, with a dose of 13.5 mg/kg over three days resulting in an 80% survival rate and minimal neurotoxic effects[1][4].

What is the projected growth of the plastic container market?

The plastic container market is expected to grow from USD 66.16 billion in 2024 to USD 101.60 billion by 2031, at a CAGR of 5.5%[5].

Which region is leading in clinical trial packaging?

North America, particularly the United States, is a leading hub for clinical trials and is expected to continue driving the demand for specialized packaging solutions[3].

What are the key drivers of the clinical trial packaging market?

The market is driven by the increasing need for specialized packaging solutions, innovations in packaging design and technology, and the shift towards personalized and precision medicine[3].

Sources

1. Preliminary Promising Findings for Manganese Chloride as a Novel Prophylactic Countermeasure Against Acute Radiation Syndrome. Academic.oup.com.
2. Global Manganese Chloride Tetrahydrate 13446 34 9 Market Report. Cognitive Market Research.
3. Clinical Trial Packaging Market Size, Growth Rate 10.80%. Towards Packaging.
4. Preliminary Promising Findings for Manganese Chloride as a Novel Prophylactic Countermeasure Against Acute Radiation Syndrome. PubMed.
5. Plastic Container Market Size, Share, Trends, Scope & Forecast. Verified Market Research.