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Bacillus Calmette-Guérin (BCG)
– a go-to therapy
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Bacillus Calmette-Guérin (BCG)
– a go-to therapy
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Progression of bladder cancer stages
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USP
9th most common cancer type globally1
App. 4 times more men than women are diagnosed1
70% to 80% of newly diagnosed bladder cancer incidents are NMIBC3
From 2022 to 2030, global incidents are projected to increase by more than 24%1
USP w. Icons
Safety
profile
Individual Case Safety Reports (ICSR) represented 0.08% of an approximative 40,000 patient cohort.
Danish Strain BCG
The thoroughly and regular evaluation of BCG Danish Strain 1331 has shown a stability of 36-months when stored appropriately
(2-8 °C protected from light).
Proficient partner
VesiCulture is produced in-house in Denmark by AJ Vaccines following best-practice standards.
Stable
supply
VesiCulture offers stable Colony Forming Unit values, low scrap rates, and dependable production output.
References
References:
FAQ
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How is risk of recurrence and progression assessed?
Risk stratification is key. The European Association of Urology (EAU) and American Urological Association (AUA) guidelines provide a framework. Assessment of tumor size, number of tumors, grade (low vs. high), presence of carcinoma in situ (CIS), and previous recurrence rates are all important factors to determine the treatment course of action. These factors considered collectively determine if risk of recurrence and progression is low, intermediate, or high, which then guides treatment and surveillance plan.
Table
| NCT Number | Study Title | Conditions | Interventions | Sponsor | Phase |
|---|---|---|---|---|---|
| NCT02773849 | ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) | Superficial Bladder Cancer | BIOLOGICAL: ADSTILADRIN | Ferring Pharmaceuticals | PHASE3 |
| NCT02449239 | ViciniumTreatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG | Bladder Cancer | BIOLOGICAL: Vicinium | Sesen Bio, Inc. | PHASE3 |
| NCT01410565 | Efficacy and Safety of Multi-Instillations of Apaziquonein Patients With Non-Muscle Invasive Bladder Cancer | Bladder Cancer | DRUG: Apaziquone|DRUG: Placebo | Spectrum Pharmaceuticals, Inc | PHASE3 |
| NCT00974818 | MitomycinC Versus Bacillus Calmette-Guerin in the IntravesicalTreatment of Non-Muscle-Invasive Bladder Cancer Patients | Bladder Cancer | DRUG: MitomycinC (MMC)|BIOLOGICAL: Bacillus Calmette-Guerin (BCG) | Memorial Sloan Kettering Cancer Center | PHASE3 |
| NCT01469221 | Efficacy and Safety Study of Apaziquonevs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) | Bladder Cancer | DRUG: Apaziquone|DRUG: Placebo | Spectrum Pharmaceuticals, Inc | PHASE3 |
| NCT02695771 | The Bladder Instillation Comparison Study | Bladder Cancer | DRUG: MitomycinC|DRUG: Gemcitabine | Spectrum Health Hospitals | PHASE3 |
| NCT04688931 | A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer | Urinary Bladder Neoplasms | DRUG: UGN-102|PROCEDURE: TURBT | UroGenPharma Ltd. | PHASE3 |
| NCT05136898 | Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC) | Bladder Cancer|Urothelial Carcinoma|Urothelial Carcinoma Bladder | DRUG: UGN-102 | UroGenPharma Ltd. | PHASE3 |
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Highlight Figure
Global Non-muscle Invasive Bladder Cancer Market Share by Treatment Type, 2023 1
Chemotherapy – 24.9%
Immunotherapy – 31.9%
Surgical Intervention – 43.2%
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High
recurrence and progression
risk if undertreated.
70-80%
of bladder cancers are
non–muscle-invasive.
Graph
Mechanism of action
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Steps
BCG therapy procedure
After TURBT surgery and a healing phase, the recommended BCG regimen begins with an induction phase, followed by a maintenance phase[8].
HEALING PHASE: 14-21 days for recovery after surgery.
INDUCTION PHASE: 2-3 weeks after TURBT, BCG is typically administered once a week for 6 weeks to stimulate the immune system to attack remaining cancer cells in the bladder lining. The goal for this repeated regimen is to challenge cancer cells and enhance the immune response against bladder cancer.
MAINTENANCE PHASE: If patients respond well to the initial treatment without serious adverse events, BCG treatment can be resumed during a maintenance phase, typically lasting 1–3 years (subject to regional and national guidelines). This involves a reduced number of treatments to help prevent recurrence, e.g. 3 weekly instillations at 3, 6, and 12 months[8].
Recommended BCG therapy procedure
Turbt
Transurethral Resection of Bladder Tumor
Day 1
Healing Phase
From day 14-21 after TURBT
Day 14
Induction Phase
Typically, 1 weekly BCG instillation
6 week period
Maintenance Phase
Typically, 3 weekly BCG instillations every
3-6 months
1-3 years