Efficacy of the Use of Neoadjuvant With/without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer: a Phase III Multi-arm, Randomized and Controlled Clinical Trial (FOXHIPECT4)

The main objective of this randomized and controlled trial is to determine whether the use of a proactive strategy, systemic neoadjuvant treatment (FOLFOX) with or without hyperthermic intraperitoneal chemoterapy (HIPEC) with mitomycin C followed by postoperative systemic adjuvant treatment, increases disease-free survival at 36 months in patients with locally advanced colon cancer compared to standard treatment. Therefore, a phase III, randomized, academic, multicenter, controlled trial will be conducted. Patients with locally advanced colon adenocarcinoma (cT4, cT3 with invasion >5mm) Nx and no metastases will be included. Control group (n=361) will receive standard treatment (surgery and adjuvant chemotherapy FOLFOX x 12 based); Experimental group 1 (n=361) = Neoadjuvant chemotherapy (FOLFOX x6) + surgery (associating HIPEC) and FOLFOX x 6; Experimental group 2 (n=361): Neoadjuvant chemotherapy (FOLFOX x6) + surgery and FOLFOX x 6. Randomization will be 1:1:1, stratified and centralized. The primary outcome will be disease-free survival at 36 months. Secondary outcomes will be tumor regression rate, ctDNA negativization, peritoneal relapse rate at 36 months, pattern of relapse, toxicity, morbidity and overall survival. Considering the results obtained with these two independent strategies (FOLFOX and HIPEC), a new trial is justified in order to provide strong evidence for this proactive treatment. The aim is to combine both to obtain a better benefit, which opens the direct possibility of increasing the current percentage of disease-free survival. The results of this study will have important scientific and social impact, since is aimed at improving the outcomes of one subpopulation of patients with locally advanced colon cancer whose current treatment, is not enough to avoid the recurrence of disease.

Start Date01 Jun 2025

Sponsor / Collaborator

Maimonides Institute for Biomedical Research of Cordoba

NCT06704191

/ RecruitingPhase 1/2IIT

MC240502 In-home iNtraVesIcal ThErapy (INVITE) Study - A Phase Ib/II, Single-Arm Trial of Delivering Intravesical Therapy for Bladder Cancer in Patients' Homes

This phase Ib/II trial compares the safety, tolerability and acceptability of intravesical chemotherapy given at home to in-clinic administration in patients with non-muscle invasive bladder cancer. Chemotherapy drugs, such as bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and 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. Standard of care chemotherapy for non-invasive bladder cancer is usually given directly into the bladder through a catheter (intravesical). This process requires numerous visits and can be disruptive to the lives of patients and caregivers. Bringing cancer care to the patients with in-home intravesical therapy may help reduce the disruption to daily lives. In-home intravesical chemotherapy may be safe and tolerable and may also be preferable to in-clinic administration in patients with non-muscle invasive bladder cancer.

Start Date21 Apr 2025

Sponsor / Collaborator

Mayo Clinic

[+1]

NCT06774131

/ Not yet recruitingPhase 3

A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-104, a Novel Formulation of UGN-101, for the Treatment of Patients With Low-grade Upper Tract Urothelial Cancer (LG-UTUC)

This study will evaluate the efficacy and safety of UGN-104, a new formulation of UGN-101 (approved in the United States and Israel as JELMYTO [mitomycin] for pyelocalyceal solution), instilled in the upper urinary tract (UUT) of patients with low-grade upper tract urothelial cancer (LG-UTUC).

Start Date15 Apr 2025

Sponsor / Collaborator

UroGen Pharma Ltd.

100 Clinical Results associated with Mitomycin

100 Translational Medicine associated with Mitomycin

100 Patents (Medical) associated with Mitomycin

27,288

Literatures (Medical) associated with Mitomycin

31 Dec 2025·Annals of Medicine

Evaluating the efficacy and safety of polyglycolic acid-loading mitomycin nanoparticles in inhibiting the scar proliferation after glaucoma filtering surgery

Article

Author: Tang, Juan ; Li, Changfen ; Liu, Xingde ; Dai, Chuanqiang ; Qi, Xing ; Liu, Guogang ; Guo, Shanlan ; Tan, Yueyue ; Xiong, Silun ; Li, Biao ; Zhang, Qinqin ; Du, Juan ; Li, Jing ; Li, Tao ; Fang, Qilin ; Wu, Xiaoli ; Li, Ying ; Li, Jiaqian ; Li, Jiaman ; Zhang, Dan

PURPOSETo prepare a polyglycolic acid-loaded mitomycin drug (MMC-ATS-@PLGA) to inhibit scar proliferation after glaucoma filtering surgery (GFS) via an anti-inflammatory mechanism that minimally affected intraocular pressure, which provided another therapeutic strategy for this disease.METHODSWe first detected the physicochemical properties of MMC-ATS-@PLGA. Next, we tested the biosafety of MMC-ATS-@PLGA in vivo and in vitro. Then, we assessed the therapeutic effects of MMC-ATS-@PLGA by laboratory and clinical examinations.RESULTSIn this study, we synthesized a new type of nanomedicine (MMC-ATS-@PLGA) with good stability and biocompatibility for inhibiting scar proliferation after GFS. The break-up time (BUT), Schimer test and intraocular pressure changes in GFS rabbits before and after treatment with MMC-ATS-@PLGA were not significantly different. Three weeks after GFS, the MMC-ATS-@PLGA group displayed significant decreases in nuclear volume, corneal cell oedema, type I and III collagen fibre expression, normal organelle morphology and collagen fibre arrangement. Compared with those in the FML and MMC groups, the α-SMA, CTGF and type III collagen fibres in the MMC-ATS-@PLGA group decreased more significantly, indicating that MMC-ATS-@PLGA can effectively inhibit the expression of these inflammatory factors during the inhibition of scar proliferation after GFS.CONCLUSIONWe successfully synthesized MMC-ATS-@PLGA, which could effectively inhibit scar proliferation after GFS via anti-inflammatory effects but had little effect on intraocular pressure. This new type of nanomedicine has good biosafety and stability and is worthy of further exploration in clinical practice.

01 Dec 2025·Child's Nervous System

Detailed analysis of hydrocephalus patterns and associated variables in patients after open fetal repair and postnatal myelomeningocele/myeloschisis closure

Article

Author: Flanders, Tracy M ; Reynolds, Tom A ; Bond, Kamila ; Gallagher, Taryn ; Adzick, N Scott ; Heuer, Gregory G ; Kundishora, Adam J ; Gebb, Juliana S ; Land, Sierra D ; Rosenfeld, Martin

AbstractBackgroundMyelomeningocele (MMC) and myeloschisis (MS) are severe neural tube defects that result in neurodevelopmental impairments and hydrocephalus due to prenatal spinal cord exposure to amniotic fluid. Fetal MMC/MS (fMMC/MS) repair has become the standard of care in appropriately selected patients, demonstrating improved outcomes, including a reduction in the need for cerebrospinal fluid (CSF) diversion compared to postnatal MMC/MS (pMMC/MS) closure. This study is a detailed analysis of the incidence, timing, and imaging predictors of hydrocephalus and CSF diversion dependence in fetal repair and postnatal closure patients in the post-MOMS trial era.MethodsA retrospective review was conducted of MMC/MS patients treated at a single institution between 2016 and 2023. Inclusion criteria required complete prenatal and postnatal follow-up data. Imaging metrics, including prenatal atrial diameter (AD) and postnatal fronto-occipital horn ratio (FOR), were analyzed alongside head circumference (HC) growth trajectories. Statistical analyses, including Youden’s index, were performed to identify predictive cutoffs for shunt dependence.ResultsAmong 333 MMC/MS patients, fetal repair significantly reduced permanent CSF diversion rates compared to postnatal closure (27.8% vs. 70.1%, p < 0.01). Timing of clinical hydrocephalus onset was delayed in fetal patients (24.2 weeks vs. 2.8 weeks, p < 0.01). HC of fetal patients was highly correlated with timing of shunt dependence. AD ≥ 10 mm and postnatal FOR ≥ 0.5 were associated with higher shunt dependence (p < 0.01). Optimal cut points for predicting shunt dependence were identified by Youden’s index as 14 mm for AD and 0.57 for early postnatal FOR.ConclusionFetal repair of MMC/MS decreases the incidence of clinical hydrocephalus and delays its onset compared to postnatal closure. Early imaging metrics (AD and FOR) may stratify hydrocephalus risk, enabling improved prenatal counseling and postnatal care. Long-term follow-up remains crucial for early detection and management of hydrocephalus in fetal MMC/MS patients.

01 Aug 2025·Journal of Pharmaceutical and Biomedical Analysis

Simultaneous analysis of various anticancer drugs by supercritical fluid chromatography-mass spectrometry. Part I: Optimization of chromatographic separation

Article

Author: Bonnabry, Pascal ; Rudaz, Serge ; Fleury-Souverain, Sandrine ; Guillarme, Davy ; Nguyen, Nathalie

This work presents a generic SFC-MS method for the simultaneous analysis of 22 anticancer drugs (fluorouracil, busulfan, cyclophosphamide, cytarabine, dacarbazine, daunorubicin, docetaxel, doxorubicin, epirubicin, etoposide, gemcitabine, idarubicin, ifosfamide, irinotecan, methotrexate, paclitaxel, pemetrexed, raltitrexed, topotecan, treosulfan, vinblastine, vincristine). The separation conditions were optimized by screening nine stationary phases (2-picolylamine, bare hybrid silica, 2-ethylpyridine, fluoro-phenyl, octadecyl, diethylamine, diol, 1-aminoanthracene, zwitterionic modification), evaluating additives effects (2-5 % water, 20-50 mM ammonium formate, 0-1 mM ammonium fluoride), and adjusting the organic modifier composition (methanol, ethanol, isopropanol, acetonitrile). The optimized SFC-MS method successfully analyzed 22 anticancer drugs, along with 5 additional challenging compounds (azacitidine, mitomycin, cisplatin, oxaliplatin, carboplatin), in 12 min, using a diol column (100 × 3 mm, 1.7 µm) and a gradient of 2-100 % methanol containing 2 % water and 50 mM ammonium formate. To overcome overpressure generated by high organic solvent content, a backpressure gradient (110-150 bar) and a flow rate gradient (0.6-1.5 mL/min) were applied. The diol column was selected as the most promising based on five predefined chromatographic criteria. Additives with 5 % water or ammonium fluoride were excluded due to overpressure and signal loss, respectively. Increasing ammonium formate concentration improved peak symmetry by 29 %. For the organic modifier, pure methanol was chosen since ternary mixtures led to system overpressure without improving separation. Comparison with the LC-MS method using real samples confirmed the potential applicability of the SFC method, as the same trace compounds were detected with comparable concentrations. Sensitivity optimization and method validation will be discussed separately in a later paper.

126

News (Medical) associated with Mitomycin

27 Apr 2025

·pipelinereview.com

UroGen Pharma Announces Encouraging Results from a Phase 1 Dose-Escalation Study Evaluating UGN-301 in Non-Muscle Invasive Bladder Cancer

PRINCETON, NJ, USA I April 26, 2025 I UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced encouraging safety data from the Phase 1 dose-escalation study for UGN-301 (zalifrelimab) intravesical solution, an investigational drug in development for the treatment of recurrent non-muscle invasive bladder cancer (NMIBC). “The early safety profile and clinical activity results from this study are encouraging,” said Jay Raman, M.D., Professor and Chair of Urology, and Professor of Surgery, Penn State Cancer Institute, PA. “This innovative approach of localized drug delivery combined with immune modulation merits additional investigation in the treatment of non-muscle invasive bladder cancer.” The multi-part clinical study included up to 30 patients per arm, aimed to assess safety and determine the recommended Phase 2 dose of UGN-301 as monotherapy and in combination with other agents. In the monotherapy arm, dose escalation continued to the maximum feasible dose. No dose-limiting toxicities and no treatment-emergent adverse events leading to treatment discontinuation were observed. This study also demonstrated that local delivery of UGN-301 formulated in our proprietary reverse thermal gel ( RTGel ® ) allowed sustained exposure of zalifrelimab in the bladder with limited systemic exposure, which mitigated the risk of systemic immune-related toxicities associated with CTLA-4 inhibition. With respect to clinical activity observed in the trial, among evaluable patients who received UGN-301, 46% (6 of 13) of those with Ta/T1 disease and 33% (2 of 6) of those with carcinoma in situ (CIS) ± Ta/T1 disease were recurrence-free or had achieved a complete response at week 12. Notably, 60% (3 of 5) of patients with Ta/T1 disease treated with 300 mg continued to remain recurrence-free at the 15-month disease assessment, including one patient with high-grade T1 disease. In the 500 mg cohort, 25% (1 of 4) of patients with CIS disease and 33% (1 of 3) of patients with Ta/T1 disease remained disease-free at six months, both of whom are still active participants in the study. These findings highlight the potential of UGN-301 as a targeted treatment for NMIBC with an acceptable safety profile. Presentation of data from the combination arms is planned for later this year. “Our hypothesis is that UGN-301’s unique formulation could potentially offer the dual benefits of maximizing therapeutic activity while minimizing systemic side effects, a key challenge in cancer immunotherapy,” said Mark Schoenberg, Chief Medical Officer, UroGen. “Although this requires additional clinical investigation, we are encouraged by the potential of UGN-301 as an investigational treatment for patients with recurrent NMIBC.” About Non-Muscle Invasive Bladder Cancer and High-Grade Disease In the U.S., bladder cancer is the second most common urologic cancer in men. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. High-grade non-muscle invasive bladder cancer (HG-NMIBC) is a serious and potentially life-threatening form of bladder cancer that remains confined to the inner layers of the bladder wall but exhibits aggressive behavior and a higher risk of progression. In the U.S., HG-NMIBC accounts for approximately 30–40% of all newly diagnosed NMIBC cases. Patients with HG-NMIBC face a significantly elevated risk of recurrence and progression to muscle-invasive disease, necessitating close surveillance and aggressive treatment. The standard of care includes complete transurethral resection of bladder tumor, often followed by intravesical therapy such as Bacillus Calmette-Guérin (BCG). However, BCG has a treatment failure rate of approximately 40-50%, leaving patients with limited treatment options short of radical cystectomy. Given the high recurrence and progression rates, HG-NMIBC presents a substantial clinical and quality-of-life burden. Upon recurrence, which occurs in approximately 70% of patients, the patients undergo another round of BCG therapy with a response rate of approximately 30%. About UGN-301 UGN-301 is an anti-CTLA-4 monoclonal antibody (zalifrelimab), originally licensed from Agenus Inc. in 2019. It is formulated with RTGel , our proprietary reverse-thermal hydrogel, for intravesical administration into the bladder. Intravesical administration of UGN-301 is designed to increase drug concentrations in the bladder without significant systemic exposure, potentially diminishing the systemic toxicity associated with CTLA-4 blockade. UroGen is evaluating UGN-301 in a multi-arm Phase 1 study of UGN-301 as monotherapy and in combination with other agents. The safety of UGN-301 is being evaluated in the monotherapy arm of the study as combination therapy for HG-NMIBC. About UroGen Pharma Ltd. UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat low-grade upper tract urothelial cancer and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade intermediate risk NMIBC are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.UroGen.com to learn more or follow us on X (Twitter), @UroGenPharma. SOURCE: UroGen Pharma

Phase 1Clinical ResultImmunotherapyDrug Approval

27 Apr 2025

·pipelinereview.com

UroGen Announces Updated 18-Month Duration of Response (DOR) of 80.6% from the Phase 3 ENVISION Trial of UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)

PRINCETON, NJ, USA I April 26, 2025 I UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced an updated 18-month DOR of 80.6% (95% CI: 74.0, 85.7), by Kaplan-Meier estimate, from the Phase 3 ENVISION trial of UGN-102 (mitomycin) for intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC. These data were featured today in an Oral Presentation Session (Abstract ID: PD12) at the AUA 2025 Annual Meeting in Las Vegas, Nevada. “This new update from the pivotal ENVISION trial of UGN-102 demonstrated a compelling probability of remaining in complete response of 80.6% at 18 months in patients who achieved a complete response (CR) at three months (79.6%),” said Sandip Prasad M.D., M.Phil., Director of Genitourinary Surgical Oncology, Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, NJ, and Principal Investigator of the ENVISION trial. “Low-grade bladder cancer is a persistent cancer that frequently recurs and comes with its own risks. There is a significant unmet need in finding treatment options for patients with recurrent low-grade bladder cancer.” The existing standard of care for LG-IR-NMIBC is an invasive surgical procedure requiring anesthesia called transurethral resection of bladder tumor (TURBT). Repeated TURBT procedures can impact patients’ physical health and quality of life and are even associated with an increased risk in mortality. Due to high recurrence rates, LG-IR-NMIBC patients, who are typically elderly with comorbidities, will likely need multiple TURBTs under general anesthesia over the course of their lifetime. An estimated 59,000 patients with LG-IR-NMIBC recur annually and face the burden and risks of repeat surgeries that often provide limited value. Mark Schoenberg, M.D., Chief Medical Officer of UroGen, stated, “The duration of response data from the ENVISION trial further underscores UGN-102’s potential to positively impact the treatment landscape for patients with recurrent LG-IR-NMIBC. Many of these patients are elderly and face the burden of repeated surgeries under general anesthesia, highlighting the urgent need for innovative treatment options. If approved, we believe UGN-102’s potential to deliver durable complete responses, reduce recurrence rates, and extend treatment-free intervals would represent a significant advancement in the management of recurrent LG-IR-NMIBC.” The most common treatment-emergent adverse events (TEAEs) in the ENVISION trial were dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention. The TEAEs were typically mild-to-moderate in severity and either resolved or were resolving. The ENVISION trial demonstrated a similar safety profile to that observed in other studies of UGN‑102. Median follow-up time at 18 months was 18.7 months after the three-month CR. UroGen completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for UGN-102 as a treatment for LG-IR-NMIBC ahead of schedule, and the FDA accepted the NDA for UGN-102 with a Prescription Drug User Free Act (PDUFA) goal date of June 13, 2025. About UGN-102 UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel ® technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting by a trained healthcare professional. UroGen completed the submission of the rolling NDA for UGN-102 in August 2024, ahead of schedule. The FDA accepted the NDA for UGN-102 and assigned a PDUFA goal date of June 13, 2025. About Non-Muscle Invasive Bladder Cancer (NMIBC) LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include TURBT as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. About ENVISION The Phase 3 ENVISION trial is a single-arm, multinational, multicenter pivotal study evaluating the efficacy and safety of UGN-102 (mitomycin) for intravesical solution as a chemoablative therapy in patients with LG-IR-NMIBC. The Phase 3 ENVISION trial completed target enrollment with 240 patients across 56 sites. Study participants received six once-weekly intravesical instillations of UGN-102. The primary endpoint evaluated the CR rate at the three-month assessment after the first instillation, and the key secondary endpoint evaluated durability over time in patients who achieved a CR at the three-month assessment. Learn more about the Phase 3 ENVISION trial at www.clinicaltrials.gov (NCT05243550). About UroGen Pharma Ltd. UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat low-grade upper tract urothelial cancer and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with LG-IR-NMIBC are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.UroGen.com to learn more or follow us on X (Twitter), @UroGenPharma. SOURCE: UroGen Pharm

Clinical ResultPhase 3NDA

22 Apr 2025

·www.prnewswire.com

SHINE Expands Global Footprint with UAE Distribution Partnership For Cancer-Fighting Isotopes

Strategic agreement with Modawina Medical Company strengthens SHINE's presence in EMEA region and advances access to Ilumira, n.c.a. lutetium 177 JANESVILLE, Wis., April 22, 2025 /PRNewswire/ -- SHINE Technologies, LLC, a nuclear fusion company with a platform of medical isotope products, today announced a strategic distribution partnership with Modawina Medical Company to bring Ilumira, SHINE's non-carrier-added lutetium-177 (n.c.a. Lu-177), to patients in the United Arab Emirates. This first-of-its-kind agreement for SHINE in the UAE extends the company's global reach and reinforces its position as a key supplier of cancer-fighting isotopes across the EMEA region. Strategic partnership to serve Middle East patients Continue Reading MMC will distribute Ilumira to its network of radiopharmaceutical manufacturers and nuclear medicine centers in the UAE. Post this Through this long-term agreement, MMC will distribute Ilumira (Lu-177) to its extensive network of radiopharmaceutical manufacturers and nuclear medicine centers in the UAE, increasing access to this important cancer-fighting isotope. Modawina Medical Company (MMC) is dedicated to equipping healthcare providers across the UAE with advanced medical technologies. Through this long-term agreement, MMC will distribute Ilumira to its extensive network of radiopharmaceutical manufacturers and nuclear medicine centers in the UAE, increasing access to this important cancer-fighting isotope. "We're proud to partner with SHINE to bring its high-quality Ilumira to healthcare providers throughout the UAE," said Ahmed Aboufaroukh, Founder and CEO of MMC. "Our mission has always been to provide cutting-edge medical solutions to the region, and this partnership allows us to address the growing demand for targeted radiotherapies that can transform cancer care." Supporting global growth in precision medicine SHINE produces Ilumira at its Cassiopeia facility in Janesville, Wisconsin, one of the highest-capacity Lu-177 production sites in North America. With the ability to support up to 100,000 doses annually, SHINE's proprietary production process ensures a reliable, high-quality supply of this important isotope, crucial given its 6.7-day half-life and need for rapid distribution. This agreement marks another step in SHINE's mission to make advanced cancer care accessible to more patients around the world. As SHINE continues to expand its global network, strategic partnerships like this one will play a vital role in strengthening the supply chain for medical isotopes and supporting the future of targeted radiopharmaceutical therapies. "The Middle East represents an exciting growth region for advanced cancer therapies, and we're proud to help lead that growth," said Greg Piefer, Founder and CEO of SHINE. "What's most exciting about expanding into the UAE with MMC, a partner with deep relationships with healthcare providers across the region, is the opportunity to deliver breakthrough cancer treatments for patients who may not have had access before." Ilumira is a critical medical isotope used in targeted cancer therapies that precisely delivers radiation to cancer cells while minimizing damage to surrounding healthy tissue. These therapies are gaining global momentum and offer powerful new options for patients with limited alternatives. Recently, the FDA expanded the approved indications for Lu-177-based radiopharmaceuticals in treating metastatic prostate cancer. About SHINE Headquartered in Janesville, Wisconsin, SHINE is an industry leader in next-generation fusion, developing innovative fusion-based technology that combines safety, cost-efficiency and environmental responsibility. SHINE has successfully commercialized fusion across multiple applications, including neutron testing markets such as neutron radiography, radiation-effects testing and fusion material research. It has commercialized and is scaling its proprietary medical isotope production processes, supplying high-quality radioisotopes essential for procedures including diagnosing heart disease and cancer as well as cancer therapy. Beyond these applications, SHINE is pioneering nuclear waste recycling to make nuclear energy more sustainable. Its long-term purpose is to change the way humans make energy by commercializing fusion energy. Unlike other fusion companies, SHINE takes a commercially driven path mirroring successful deep-tech industries. Through this visionary approach, SHINE is advancing technology, healthcare, and sustainable energy, making a lasting impact across multiple sectors. Learn more at About Modawina Medical Company Modawina Medical Company (MMC) was established in 2010 to meet the growing demands of healthcare services in the United Arab Emirates. As a trusted partner of leading global medical equipment manufacturers, MMC provides premium healthcare solutions with exceptional after-sales service. The company's comprehensive product portfolio includes advanced equipment for Radiology, Nuclear Medicine, Surgical Instruments, Medical Oncology, Laboratory and Physiotherapy used in hospitals throughout the region. A private enterprise dedicated to serving healthcare providers across the Middle East, MMC is committed to supplying superior equipment while maintaining the highest standards of patient care. The company continuously expands its product offerings to fulfill market demands, ensuring healthcare facilities have access to the best-known brands in the medical field. Through its commitment to quality and service excellence, MMC continues to support the advancement of healthcare delivery throughout the UAE and beyond. Learn more at SOURCE SHINE Technologies, LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Radiation Therapy

100 Deals associated with Mitomycin

External Link

KEGG	Wiki	ATC	Drug Bank
D00208	Mitomycin	L01DC03	DB00305

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Transitional Cell Carcinoma	United States	UroGen Pharma Ltd.	15 Apr 2020
Bladder Cancer	Australia	OMEGAPHARM PTY LTD	08 Mar 2016
Hepatocellular Carcinoma	Australia	OMEGAPHARM PTY LTD	08 Mar 2016
Non-Small Cell Lung Cancer	Australia	OMEGAPHARM PTY LTD	08 Mar 2016
Glaucoma	United States	Mobius Therapeutics LLC	07 Feb 2012
Adenocarcinoma	United States	Hikma Pharmaceuticals USA, Inc.	19 Apr 1995
Breast Cancer	China	Huangshi Huangkang Pharmaceutical Co. Ltd.	01 Jan 1992
Colorectal Cancer	China	Huangshi Huangkang Pharmaceutical Co. Ltd.	01 Jan 1992
Esophageal Carcinoma	China	Huangshi Huangkang Pharmaceutical Co. Ltd.	01 Jan 1992
Ovarian Cancer	China	Huangshi Huangkang Pharmaceutical Co. Ltd.	01 Jan 1992
Colonic Cancer	Japan	Kyowa Kirin Co., Ltd.	25 Sep 1963
Endometrial Carcinoma	Japan	Kyowa Kirin Co., Ltd.	25 Sep 1963
Head and Neck Neoplasms	Japan	Kyowa Kirin Co., Ltd.	25 Sep 1963
Liver Cancer	Japan	Kyowa Kirin Co., Ltd.	25 Sep 1963
Lung Cancer	Japan	Kyowa Kirin Co., Ltd.	25 Sep 1963
Lymphoid Leukemia	Japan	Kyowa Kirin Co., Ltd.	25 Sep 1963
Pancreatic Cancer	Japan	Kyowa Kirin Co., Ltd.	25 Sep 1963
Philadelphia chromosome positive chronic myelogenous leukemia	Japan	Kyowa Kirin Co., Ltd.	25 Sep 1963
Stomach Cancer	Japan	Kyowa Kirin Co., Ltd.	25 Sep 1963
Uterine Cervical Cancer	Japan	Kyowa Kirin Co., Ltd.	25 Sep 1963

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Non-Muscle Invasive Bladder Neoplasms	NDA/BLA	United States	UroGen Pharma Ltd.	24 Jan 2024
Urothelial Carcinoma of the Urinary Bladder	Phase 3	Serbia	UroGen Pharma Ltd.	19 Feb 2021
Urothelial Carcinoma of the Urinary Bladder	Phase 3	Latvia	UroGen Pharma Ltd.	19 Feb 2021
Renal Pelvis and Ureter Urothelial Carcinoma	Phase 2	United States	UroGen Pharma Ltd.	04 Apr 2017
Renal Pelvis and Ureter Urothelial Carcinoma	Phase 2	Israel	UroGen Pharma Ltd.	04 Apr 2017
Bladder Cancer	Phase 2	United States	CG Oncology, Inc.	01 Mar 2014
Carcinoma in Situ	Phase 2	United States	CG Oncology, Inc.	01 Mar 2014
Glaucoma, Neovascular	IND Application	Estonia	Pro Top & Mediking Company Limited	01 Jul 2007
Glaucoma, Open-Angle	IND Application	Estonia	Pro Top & Mediking Company Limited	01 Jul 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02793128 (OLYMPUS, Pubmed \| J Urol)	Phase 3	Renal Pelvis and Ureter Urothelial Carcinoma	71	UGN-101	nodnvmtlal(mfbevxxabb) = fgeudxxaru biktmtxcqx (qvsgjwczgu, 27.9 - 65.3) View more	Positive	01 Mar 2025
EudraCT 2021-003751-42 (ICH-013, ASCO_GU2025) Manual	Phase 3	Non-Muscle Invasive Bladder Neoplasms Neoadjuvant	63	mitomycin	(csnwbliraw) = scsijmlbls vfvnxismwo (uwnwaniwpu ) View more	Positive	13 Feb 2025
EudraCT 2021-003751-42 (ICH-013, ASCO_GU2025) Manual	Phase 3	Non-Muscle Invasive Bladder Neoplasms Neoadjuvant	63	STA	(kalxntlwtk) = patvnopksy nmkaidfhhc (yebalsszll ) View more	Positive	13 Feb 2025
ASCO_GI2025	Not Applicable	squamous cell carcinoma of the anus	118	MMC 12mg/m2	(adbhhxdnwh) = otezrgjywm nrkbjgsjlk (jkfdkqvtsa ) View more	-	23 Jan 2025
ASCO_GI2025	Not Applicable	squamous cell carcinoma of the anus	118	MMC 10mg/m2x2 doses	(adbhhxdnwh) = exbnytmpzf nrkbjgsjlk (jkfdkqvtsa ) View more	-	23 Jan 2025
NCT02793128 (OLYMPUS, Company_Website) Manual	Phase 3	Renal Pelvis and Ureter Urothelial Carcinoma	71	JELMYTO	(noajwmixbb) = dbpdspmmvm qizcagrpij (fksplxfurz, 13.1 - 57.5) View more	Positive	26 Nov 2024
NCT05243550 (ENVISION, CTgov)	Phase 3	Urothelial Carcinoma of the Urinary Bladder \| Non-Muscle Invasive Bladder Neoplasms	240	UGN-102	(vvbqvtsevd) = azeqrmixxw jglwtrwpyh (eyccjjircd, cucfesyxoz - mqubpqljry) View more	-	04 Nov 2024
NCT05243550 (ENVISION, Pubmed \| J Urol) Manual	Phase 3	Non-Muscle Invasive Bladder Neoplasms	240	UGN-102 (mitomycin)	(mwrcgprljj) = zhkbwdssva ywgxvuxzcv (wdlnbyhdli, 73.9 - 84.5) View more	Positive	24 Oct 2024
NCT02040142 (CTgov)	Phase 2	Malignant Mesothelioma of Peritoneum \| Pseudomyxoma Peritonei \| Appendiceal Neoplasms \| Colorectal Cancer \| Peritoneal Neoplasms \| Stomach Cancer	51	HIPEC+Mitomycin C	wpygkduxio(sedzioutvb) = ybajkbwzjf dbbdocktrf (pdzpkagcwa, dhpwpdcpup - zhmtsrzjmu) View more	-	24 Oct 2024
NCT05136898 (CTgov)	Phase 3	Urothelial Carcinoma of the Urinary Bladder \| Non-Muscle Invasive Bladder Neoplasms	8	UGN-102	bmoflzlzmi(mlnaiuxjzy) = mntyqdccbh wiipxjiysq (cgpqqdjult, imrsstcpjf - jqttfnxwem) View more	-	19 Sep 2024
EUCTR2019-000922-23-DE (IRITACE, ESMO2024) Manual	Phase 2	Hepatocellular Carcinoma	20	DEB-TACE with Irinotecan and Mitomycin C	(ygeikdkqmx) = eewsiquvkm nmhprjhing (xyoosldwer ) View more	Negative	16 Sep 2024
EUCTR2019-000922-23-DE (IRITACE, ESMO2024) Manual	Phase 2	Hepatocellular Carcinoma	20	DEB-TACE with Doxorubicin	(ygeikdkqmx) = xkimtvcivr nmhprjhing (xyoosldwer ) View more	Negative	16 Sep 2024
NCT05243550 (ENVISION, Biospace) Manual	Phase 3	Non-Muscle Invasive Bladder Neoplasms	108	UGN-102 (mitomycin)	(zutjffffua) = updxbnednl lqkxnagjhc (nutlynecaj, 73.9 - 84.5) View more	Positive	13 Jun 2024

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