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

Trial Profile

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

Completed
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
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top