Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase 3, Randomized, Active-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of EN3348 (MCC) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent or Refractory Non-Muscle Invasive Bladder Cancer

Next Previous
Trial Profile

A Phase 3, Randomized, Active-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of EN3348 (MCC) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent or Refractory Non-Muscle Invasive Bladder Cancer

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 12 Nov 2019

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Mycobacterium cell wall DNA complex (Primary) ; Mitomycin
  • Indications Bladder cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms EMBARC-RF
  • Sponsors Endo Pharmaceuticals

    • 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, results from this trial were published in The Journal of Urology.
    • 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.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Legal
Back to top