# Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer

> **NCT01200992** · PHASE3 · TERMINATED · sponsor: **Bioniche Life Sciences Inc.** · enrollment: 84 (actual)

## Conditions studied

- Bladder Neoplasm
- Neoplasm Recurrence, Local
- Transitional Cell, Carcinoma
- Carcinoma in Situ
- Mycobacterium

## Interventions

- **BIOLOGICAL:** EN3348
- **BIOLOGICAL:** Mitomycin C

## Key facts

- **NCT ID:** NCT01200992
- **Lead sponsor:** Bioniche Life Sciences Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2010-11
- **Primary completion:** 2013-04
- **Final completion:** 2013-12
- **Target enrollment:** 84 (ACTUAL)
- **Why stopped:** Lack of Recruitment
- **Last updated:** 2017-08-24


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01200992

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01200992, "Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT01200992. Licensed CC0.

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