Our lead product is DCVax-L for Glioblastoma multiforme (“GBM”), the most lethal form of primary brain cancer. We have completed two Phase I/II trials and are now well under way with a large Phase III trial, as described below.
With full standard of care treatment for GBM today, including surgery, radiation and chemotherapy, the median time from surgery to remove the initial tumor to the time of tumor recurrence is just 6.9 months, and median survival is just 14.6 months. There has been very little improvement in clinical outcomes for GBM patients in the last 30 years. The incidence of GBM appears to be on the rise, for unknown reasons, and there is an urgent need for new and better treatments.
Our Prior Phase I/II DCVax-L Trials for GBM
We, together with our collaborator, Dr. Linda Liau, conducted two prior Phase I/II clinical trials at UCLA with DCVax-L for GBM brain cancer. Those trials consisted of 39 patients, including 20 patients with newly diagnosed GBM and 19 patients recurrent GBM and other gliomas. The newly diagnosed patients who received DCVax in addition to standard of care treatment typically did not have tumor recurrence for a median of approximately 2 years (more than triple the usual time with standard of care treatments), and they survived for a median of approximately 3 years (about 2½ times the usual period of survival with standard of care treatment).
Furthermore, a substantial percentage of patients who received DCVax-L in the prior Phase I/II clinical trials have continued in a “long tail” of survival far
beyond even the 3 year median survival. As of the latest long-term data update in July, 2011, 33% of the patients had reached or exceeded 4 years’ median survival and 27% had reached or exceeded 6 years’ median survival. As of this year, 2 of the Phase I/II clinical trial patients have exceeded 10 years’ survival (compared with 14.6 months’ median survival with full standard of care treatment today).
Our Current Phase III Trial
We are currently conducting a 348-patient double blind, randomized, placebo controlled Phase III clinical trial with DCVax-L for newly diagnosed GBM. The primary endpoint of the trial is “Progression Free Survival,” meaning the length of time that a patient continues without disease progression (i.e., recurrence of the tumor). Secondary endpoints include overall survival and other measures.
The trial is under way at 51 sites (medical centers) across the US. The sites and the eligibility criteria are listed in the profile of the trial at ClinicalTrials.gov. The trial is also under way in Europe. The lead site is Kings College Hospital in London. Approximately 30 trial sites are also in varying stages of preparation in the U.K. and Germany.