NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

The transition from a Phase II to Phase III trial was completed around May, 2012.

MAY 17
2012
Northwest Bio Provides Update On DCVax® -L Brain Cancer Trial
Amendment Accepted By FDA, Enhancing and Upgrading the Trial

41 US Clinical Trial Sites Now In Operation

BETHESDA, MD, May 17, 2012 — Northwest Biotherapeutics (OTC.BB: NWBO) (NW Bio) announced today that it now has 41 clinical trial sites open and recruiting across the United States in its ongoing clinical trial of DCVax®-L immune therapy for Glioblastoma multiforme (GBM), the most lethal form of brain cancer. This is ahead of the Company’s previous projection of 40 sites by the end of Q2, 2012. The Company plans to continue adding clinical trial sites in the US and Europe, and expects to have at least 60 sites open and enrolling by the end of Q3, 2012.

The Company also announced that the FDA has accepted an amendment of the clinical trial, which does not make any change in the treatment regimen, which leaves all data collected to date intact for use in the trial’s overall results, and which includes the following:

Designation as a Phase III trial
Expanded and enhanced statistical endpoint analyses
Addition of another cohort of patients which can potentially expand the application
of DCVax®-L, and which increases the trial to up to 300 patients
Addition of interim analyses for efficacy
A description of the trial protocol as amended will be available at www.clinicaltrials.gov.

Linda Powers, CEO of Northwest Bio, commented, “Of course, the evolution of this trial to a Phase III trial is no assurance of the outcome, and more than one Phase III trial can often be required for a product approval unless the clinical results are particularly strong. However, we are pleased to make this transition to Phase III, and believe that the package of amendments further enhances an already strong trial, positioning the Company to realize the potential of the DCVax®technology.”

Ms. Powers added, “We are excited about the operational progress we have made on multiple fronts, through long periods of work building to these points, as described in our recent announcements. Our lead clinical trial has grown and emerged as a 300-patient, international Phase III trial involving some of the best institutions in the US, UK and Germany. We are also working on several other initiatives, and will provide reports when milestones are reached in those programs.”

https://nwbio.com/northwest-bio-provides-update-on-dcvax-l-brain-cancer-trial-2/

They claimed to be doing equivalency studies for L with TFF in their SEC filings, but then that reference was just dropped from their filings. I'd have to check as to when that claim went away.