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Press Release Source: Northwest Biotherapeutics
Northwest Biotherapeutics to Present Updated Brain Cancer Data at the International Society for Cellular Therapy Annual Meeting
Wednesday May 3, 2006
Personalized Brain Cancer Vaccine Continues to Produce Very Promising Results
Northwest Biotherapeutics today announced that the company will be presenting updated data from the second Phase I clinical trial on patients who have received DCVax®-Brain, a personalized therapeutic cancer vaccine, at the 12th Annual Meeting of the International Society for Cellular Therapy (ISCT), being held May 4-7, 2006 in Berlin.
Marnix Bosch, PhD, MBA, Vice President of Vaccine Research and Development for Northwest Biotherapeutics, will present updated survival and progression data, accumulated through April 2006, at his presentation on Saturday, May 6th at 5:45 pm. Dr. Bosch will also be available immediately following the presentation to discuss the findings, and the Phase II development of DCVax®-Brain as a promising new cancer therapy.
A program to provide booster immunizations to surviving patients in this Phase I trial was recently allowed by the FDA, and initiated at UCLA. Dr. Bosch commented on the booster vaccine program: "The booster immunizations are expected to further enhance the protective anti-tumor immune response in these surviving patients. We hope that this program will allow continued lengthening of survival times."
The Phase I clinical trial of DCVax®-Brain involved patients with Glioblastoma multiforme (GBM) one of the deadliest forms of brain cancer. GBM has median times to progression and death of approximately 8 and 15 months, respectively. Primary therapy for GBM, involving surgery followed by radiotherapy and concurrent chemotherapy, creates a low tumor burden environment that can be ideal for immunotherapy approaches. Dendritic cell-based immunotherapy, such as that by Northwest Biotherapeutics in its DCVax®-Brain vaccine, uses autologous dendritic cells pulsed with tumor biomarkers (antigens). This therapeutic approach aims at safely stimulating anti-tumor immune responses to prevent tumor recurrence or progression.
As previously reported by the Company, the following findings had been observed and reported for the Phase I clinical trial of DCVax®-Brain as of three months ago, in February 2006:
-- 8 of 10 patients still alive, with median survival of 20.5 months and continuing;
-- 4 of 10 patients survived over 30 months and were continuing, and 5 of 10 patients survived over 24 months and were continuing;
-- 8 of 10 patients surpassed the historical control median survival of 15 months, with other patients still continuing toward that point;
-- Survival times to date ranged from 11.2 months to 39.0 months, and continuing;
-- 5 of 10 patients continued to show no signs of cancer, with median follow-up time of 32 months;
-- Median time to progression (i.e., tumor recurrence) was 14.7 months and continuing;
-- 9 of 10 patients had surpassed the historical median time to progression of 8 months.
The findings as of April 15th, 2006 will be announced after this week´s presentation at the ISCT meeting in Berlin.