CLINICAL TRIALS PROFILE FOR MITOZYTREX

All Clinical Trials for MITOZYTREX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01004978 ↗	Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2009-10-28	This randomized phase III trial studies chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treating patients with liver cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, mitomycin, and cisplatin, 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. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumor and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving chemoembolization together with sorafenib tosylate is more effective than chemoembolization alone in treating patients with liver cancer.
NCT01017640 ↗	Veliparib With or Without Mitomycin C in Treating Patients With Metastatic, Unresectable, or Recurrent Solid Tumors	Completed	National Cancer Institute (NCI)	Phase 1	2009-10-01	This phase I trial studies the side effects and best dose of veliparib when given with or without mitomycin C in treating patients with solid tumors that have spread to other places in the body, cannot be removed by surgery or have come back. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as mitomycin C, 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. Giving veliparib together with mitomycin C may kill more tumor cells.
NCT02891447 ↗	Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2016-09-01	This phase II trial studies how well heated mitomycin and cisplatin during surgery work in treating patients with stomach or gastroesophageal cancer. Drugs used in chemotherapy, such as mitomycin and cisplatin, 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. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells.
NCT02891447 ↗	Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer	Active, not recruiting	M.D. Anderson Cancer Center	Phase 2	2016-09-01	This phase II trial studies how well heated mitomycin and cisplatin during surgery work in treating patients with stomach or gastroesophageal cancer. Drugs used in chemotherapy, such as mitomycin and cisplatin, 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. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells.
NCT03617913 ↗	Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2018-09-19	This phase II trial studies the side effects of avelumab and how well it works in combination with fluorouracil and mitomycin or cisplatin and radiation therapy in treating participants with muscle-invasive bladder cancer. Monoclonal antibodies, such as avelumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as fluorouracil, mitomycin, and cisplatin, 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. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving avelumab with chemotherapy and radiotherapy may work better in treating participants with muscle-invasive bladder cancer.
NCT03617913 ↗	Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer	Completed	Mayo Clinic	Phase 2	2018-09-19	This phase II trial studies the side effects of avelumab and how well it works in combination with fluorouracil and mitomycin or cisplatin and radiation therapy in treating participants with muscle-invasive bladder cancer. Monoclonal antibodies, such as avelumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as fluorouracil, mitomycin, and cisplatin, 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. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving avelumab with chemotherapy and radiotherapy may work better in treating participants with muscle-invasive bladder cancer.
NCT03775265 ↗	Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer	Recruiting	National Cancer Institute (NCI)	Phase 3	2019-04-19	This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

Clinical Trial Conditions for MITOZYTREX

Condition Name

Condition Name for MITOZYTREX
Intervention	Trials
Stage IIIA Bladder Cancer AJCC v8	3
Stage III Bladder Cancer AJCC v8	3
Stage II Bladder Cancer AJCC v8	2
Bladder Carcinoma Infiltrating the Muscle of the Bladder Wall	2

Condition MeSH

Condition MeSH for MITOZYTREX
Intervention	Trials
Carcinoma	6
Carcinoma, Transitional Cell	3
Urinary Bladder Neoplasms	3
Carcinoma, Squamous Cell	2

Clinical Trial Locations for MITOZYTREX

Trials by Country

Trials by Country for MITOZYTREX
Location	Trials
United States	163

Trials by US State

Trials by US State for MITOZYTREX
Location	Trials
Minnesota	6
Kentucky	5
Florida	5
Texas	5
California	5

Clinical Trial Progress for MITOZYTREX

Clinical Trial Phase

Clinical Trial Phase for MITOZYTREX
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	7
Phase 1	1

Clinical Trial Status

Clinical Trial Status for MITOZYTREX
Clinical Trial Phase	Trials
Not yet recruiting	3
Recruiting	3
Active, not recruiting	2

Clinical Trial Sponsors for MITOZYTREX

Sponsor Name

Sponsor Name for MITOZYTREX
Sponsor	Trials
National Cancer Institute (NCI)	10
Mayo Clinic	2
M.D. Anderson Cancer Center	1

Sponsor Type

Sponsor Type for MITOZYTREX
Sponsor	Trials
NIH	10
Other	5

MITOZYTREX Market Analysis and Financial Projection

MITOZYTREX: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

MITOZYTREX, a formulation of mitomycin, is a significant player in the treatment of various cancers, particularly in the realm of non-muscle invasive bladder cancer (NMIBC). This article delves into the latest updates on clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

UGN-102 Clinical Trials

UGN-102, a sustained-release, hydrogel-based formulation of mitomycin, has shown promising results in recent clinical trials. In the Phase 3 ATLAS trial, UGN-102 demonstrated superiority over the standard treatment, Transurethral Resection of Bladder Tumor (TURBT), with a 55% reduction in the risk of recurrence, progression, or death[1].

The ENVISION trial also met its primary endpoint, showing a complete response rate of 79.2% at three months following the initial treatment. These trials indicate that UGN-102 could be the first non-surgical therapy for low-grade, intermediate-risk NMIBC, offering a significant advancement in treatment options[1].

UGN-103 Clinical Trials

UGN-103, a next-generation mitomycin-based formulation using the RTGel® platform technology, is currently in Phase 3 clinical trials. The UTOPIA study aims to evaluate the efficacy and safety of UGN-103 in patients with LG-IR-NMIBC. Patients receive 75 mg of UGN-103 via intravesical instillation once a week for six weeks, with efficacy assessed by the complete response rate at the three-month visit[4].

Market Analysis

Global Mitomycin Market

The global mitomycin market is experiencing significant growth, driven primarily by the increasing incidence of cancer worldwide. As of 2023, the global mitomycin market size was valued at USD 175.7 million and is projected to grow to USD 384.76 million by 2032, with a compound annual growth rate (CAGR) of 9.1% during the forecast period[5].

Segment Analysis

The mitomycin market is segmented based on type, application, and region. The cancer treatment segment dominates the market, with mitomycin being effective against various types of cancer, including gastric, pancreatic, breast, non-small cell lung, cervical, prostate, and bladder cancers[5].

Regional Analysis

The Asia Pacific region is emerging as a lucrative market for mitomycin, with Japan and India being key contributors. The increasing production and demand in these countries are expected to boost the region's prominence in the global market[5].

Market Projections

Growth Drivers

The mitomycin market is driven by several factors, including the increasing incidence of cancer, the broad clinical antitumor spectrum of mitomycin, and advancements in formulation technologies like RTGel®. The growing demand for non-surgical and minimally invasive treatments also contributes to the market's growth[5].

Market Restraints

Despite the positive outlook, the market faces restraints such as increasing costs and the need for continuous innovation to maintain competitiveness. However, these challenges are being addressed by leading manufacturers through strategic expansions and research investments[5].

Competitive Landscape

Key Players

Companies like UroGen Pharma, Kyowa Kirin, and Teva are actively involved in the development and commercialization of mitomycin-based formulations. UroGen Pharma, in particular, is at the forefront with its UGN-102 and UGN-103 formulations, which are poised to transform the treatment landscape for NMIBC[1][4].

Future Outlook

Regulatory Approvals

UroGen Pharma has completed the New Drug Application (NDA) submission for UGN-102 ahead of schedule, with potential FDA approval anticipated in early 2025. This approval could significantly impact the market by offering a non-surgical treatment option for LG-IR-NMIBC patients[4].

Technological Advancements

The RTGel® platform technology used in UGN-103 is expected to further enhance the therapeutic profiles of mitomycin-based formulations. This technology allows for sustained release and longer exposure of bladder tissue to mitomycin, improving treatment efficacy[4].

Key Takeaways

• Clinical Trials Success: UGN-102 has demonstrated significant efficacy in reducing the risk of recurrence, progression, or death in NMIBC patients.
• Market Growth: The global mitomycin market is projected to grow at a CAGR of 9.1% from 2024 to 2032.
• Regional Expansion: The Asia Pacific region, particularly Japan and India, is expected to play a crucial role in the market's growth.
• Technological Advancements: Next-generation formulations like UGN-103 using RTGel® technology are set to improve treatment outcomes.
• Regulatory Milestones: Potential FDA approval of UGN-102 in early 2025 could mark a significant shift in NMIBC treatment.

FAQs

What is MITOZYTREX?

MITOZYTREX refers to formulations of mitomycin, such as UGN-102 and UGN-103, used in the treatment of non-muscle invasive bladder cancer (NMIBC).

What are the key findings from the ATLAS and ENVISION trials?

The ATLAS trial showed a 55% reduction in the risk of recurrence, progression, or death, while the ENVISION trial demonstrated a complete response rate of 79.2% at three months following treatment with UGN-102[1].

What is the RTGel® platform technology?

RTGel® is a proprietary sustained-release, reverse-thermal hydrogel technology used in UGN-103 to improve the therapeutic profile of mitomycin by enabling longer exposure of bladder tissue to the drug[4].

What is the projected market size of the global mitomycin market by 2032?

The global mitomycin market is projected to grow to USD 384.76 million by 2032, with a CAGR of 9.1% during the forecast period[5].

Which regions are expected to drive the growth of the mitomycin market?

The Asia Pacific region, particularly Japan and India, is expected to drive significant growth in the mitomycin market due to increasing production and demand[5].

Sources

1. UGN-102, in Development as the Potential First Non-Surgical Therapy for LG-IR-NMIBC, Met Primary Endpoints in Both Phase 3 ATLAS and ENVISION Clinical Trials. UroGen Pharma.
2. Mitomycin Market Report 2024 (Global Edition). Cognitive Market Research.
3. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025. GlobalData.
4. First Patient Dosed in Phase 3 Clinical Trial of UGN-103, a Next-Generation Mitomycin-Based Formulation in Development for the Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer. Biospace.
5. Mitomycin Market Size, Growth & Trends Report | 2032. SkyQuest Technology Consulting.