Open-Label, Multi-Center Study of the Efficacy and Safety of MCC in the Treatment of Patients With Non-Muscle Invasive (Superficial) Bladder Cancer at High Risk of Progression and Who Are Refractory to BCG
Phase of Trial: Phase II/III
Latest Information Update: 02 Feb 2016
At a glance
- Drugs Mycobacterium cell wall DNA complex (Primary)
- Indications Bladder cancer
- Focus Registrational; Therapeutic Use
- Sponsors Bioniche Life Sciences
- 02 Feb 2016 According to a Telesta Therapeutics media release, the FDA has issued a Complete Response Letter to company's Biologics License Application (BLA) for MCNA. The FDA has communicated that an additional Phase III clinical trial for MCNA would be necessary to adequately establish MCNA's efficacy and safety.
- 28 Aug 2015 According to a Telesta Therapeutics media release, the FDA has completed its initial review of Biologics License Application (BLA) submitted on June 29, 2015 and has accepted it for filing. The FDA has designated the file for 6 month Priority Review and has set February 27, 2016 as the review goal date for MCNA.
- 13 Feb 2015 According to a Telesta Therapeutics media release, the filing of a Biologics License Application (BLA) with the US FDA is planned on 30 June 2015, based on data from this trial and another phase III trial.