Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax®-L personalized immune therapies for solid tumor cancers, today announced that its Phase III clinical trial with DCVax®-L for brain cancer has been initiated at King's College Hospital in the UK.
This is one of the first late-stage clinical trials in Europe with active immune therapies, and its opening is the culmination of years of planning, development and regulatory and institutional approvals. King's College Hospital, a major center for neuro-oncology, is leading the way for the many other European sites. Three other sites in the UK are also preparing to open, and nearly 20 sites in Germany are in various stages of preparation. In addition, medical centers in other European countries have requested to be added to the trial.
This Phase III trial is for newly diagnosed Glioblastoma multiforme (GBM), the most common and most lethal form of brain cancer. The trial is already well under way in the US, with 46 active sites at present, and is expected to enroll an aggregate total of 312 patients in the US and Europe. Notably, there are few competing brain cancer trials in Europe, although Europe has a population larger than the US.
DCVax-L mobilizes a cancer patient's whole immune system to attack the full set of biomarker targets on the tumor. Current standard of care for GBM brain cancer includes surgical removal of the tumor, followed by six weeks of daily radiation to the brain and daily chemotherapy, followed by monthly chemotherapy. With all of these treatments, GBM tumors typically recur within about 6.9 months, and the patients typically live for about 14.6 months. In prior Phase I/II clinical trials, in patients treated with DCVax-L the tumors typically did not recur for 2 years, and the patients typically lived for 3 years. A substantial percentage of patents lived even longer, and to date two patients have exceeded 10 years. In addition, DCVax-L is non-toxic and is anticipated to cost less than other recent cancer drugs.
Dr. Keyoumars Ashkan, Consultant Neurosurgeon [specialist] and Lead for Neuro-Oncology at King's College Hospital said: "We are pleased to be leading the way in bringing these novel immune therapies to patients in the UK. Brain cancers are some of the most lethal cancers, and there is a great need for new and better treatments."
"The positive data from the clinical trials in the US were very encouraging in delaying disease progression and extending survival times, without significant toxic side effects. We are hopeful that similar results will be seen in the large, randomized clinical trial which we have now launched in the UK."
"This is an important landmark, as we begin patient recruitment in our pioneering Phase III trial of DCVax-L for brain cancer in Europe, the largest medical market in the world after the US," commented Linda Powers , CEO of NW Bio. "This is one of the first late-stage clinical trials with active immune therapies in Europe, and is bringing patients a much needed new treatment option. We are excited to be launching this trial with King's College Hospital, one of Europe's premier opinion-leader institutions."
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