On May 17, 2012, Northwest Biotherapeutics (NASDAQ:NWBO) announced that it already 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 plans to have total of 80 sites for the trial.
The Company also announced that the FDA has accepted an amendment of the clinical trial. The amendment 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. The amendment includes the following:
- The previous Phase II trial has been designation as a Phase III trial;
- Expanded and enhanced statistical endpoint analyses;
- With the addition of another cohort of patients which can potentially expand the application of DCVax-L, the trial size has been increased up to 300 patients from previous 240 patients;
- Addition of interim analyses for efficacy;
As a reminder, the previous Phase II trial of DCVax-L is an ongoing randomized, placebo controlled, double blinded (2:1) study with a cross-over arm allowing control patients to be treated with DCVax-L in the event that their cancer progresses. The primary end point is progression free survival (NYSE:PFS) with overall survival (OS) as the secondary end point. The original 240-patient trial is designed to enable the Company to petition the FDA for accelerated approval if the study generates results similar to those achieved in the two prior Phase I clinical trials.
Our Immediate Takeaways
This announcement is another indication that NWBO is making further progress in its key program DCVax-L for brain cancer.
The Company has continuously beats its expectations about adding new clinical trial sites. In addition, the official designation of the previous Phase II trial of DCVax-L as a Phase III trial makes DCVax-L one step closer to the market. This is also a further indication that management is making every effort to make this breakthrough medicine to brain cancer patients around the world though the evolution of this trial to a Phase III trial is no assurance of the outcome.
In order to accelerate the clinical trial and expand it to Europe, the Company established two partnerships in April. One is with the Fraunhofer IZI Institute in Germany, and another one is with King's Health Partners in London, Britain. Both institutions are prestigious health organizations in Europe. We think the two partnerships in Germany and Britain are very encouraging news and positive to NWBO in the following aspects:
- The two partnerships will help accelerate the Company's ongoing international Phase II clinical trial of DCVax-L for GBM (designed and powered as a pivotal trial). Data from Germany and Britain combined with US clinical sites could form the basis for the submission of a BLA in the US and EU.
- The compassionate use of DCVax-L will help extend lives for other patients who are not qualified while the trials are ongoing. It may also bring some additional revenues for the Company although it won't be material in our view.
- The collaborations also expand NWBO's manufacturing capacity and flexibility for DCVax® products, without the need for any capital investment by the Company.
- Overall, the partnerships with King's Health Partners and the Fraunhofer IZI Institute provide solid foundation for NWBO's programs in Europe upon which NWBO can proceed with clinical trials in Europe, and with compassionate use treatments of patients in parallel with such clinical trials.
With the new announcement about the trial sites update and amendment to the Phase II trial, the Company's lead program has advanced and emerged as 300-patient, international Phase III trial, involving some of the best institutions in the US, UK and Germany.
The Company plans to petition for product approval in the U.S. and/or the European Union if the Phase III trial results are positive. In such a case, DCVax-L could potentially be the second active immunotherapy for cancer in the US and the first active immunotherapy for cancer in the EU.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.