Tuesday, April 03, 2012 8:18:55 PM
http://seekingalpha.com/article/473161-c...
I think Mr. Norris needs to double check or be more specific on where his data is provided as his facts of ICT-107 vaccine results against a tumor lysate vaccine (NWBO) show different results as noted below from public records and can be misleading. He shows medium profession free survial for ICT-107 at 16.9 months and NWBO as noted below at 26.4 months and median survival for ICT-107 at 38.4 months versus 36.4 months for NWBO. The long term survival data is impressive for both companies. I am investor in both companies but just thought it would be helpful to point this out to the board.
There have been two prior DCVax® clinical trials (Phase I and Phase I/II) in newly diagnosed and recurrent glioblastoma multiform patients (n=29): 10 were recurrent and 19 were newly diagnosed. The median survival for patients receiving standard of care has been shown to be 14.6 months, where standard of care includes surgery, radiation therapy and Temodar (Schering Plough).
For newly diagnosed glioblastoma patients, the latest long-term follow-up data from the previous two trials (as of September 2009), shows median progression-free survival in patients treated with DCVax® of 26.4 months (vs. 6.9 months with standard of care) and a median survival of 36.4 months (vs. 14.6 months with standard of care). So far, 85% of newly diagnosed patients treated with DCVax®-Brain have survived longer than 14.6 months – the median survival with standard of care (surgery, radiation therapy and Temodar). Up until September 2009, 22% of patients have survived for more than six years (compared to less than 5% of patients who survive for five years on standard of care), and up until September 2009, 74% of patients have been free of recurrence for one year, 45% for two years, 33% for three years, 28% for four years and 22% for five years. These studies are generating ongoing data.
After the radiation and initial chemotherapy stages, the DCVax® is alternated with cycles of follow-up chemotherapy. There are no debilitating side effects from the DCVax® (e.g., no hair loss and no nausea), thereby providing a superior quality of life. In the clinical studies seen to date, the return of cancer is delayed from 6.9 to 26.4 months. Survival is also extended from 14.6 to 36.4 months (Figure 2).
Figure 2: Newly Diagnosed Glioblastoma Brain Cancer Patients Stupp Data* (Standard of Care) DCVax®-Brain
Time to recurrence 6.9 months (SOC) vs 26.4 months DCVax
Overall median survival 14.6 months (SOC) vs 36.4 months DCVax
Source: Northwest Biotherapeutics, *Stupp data from a 573 patient trial is the benchmark for GBM brain cancer patients. N Engl J Med 352:987-96, 2005
In previous studies, DCVax®-Brain doubled two and three-year survival rates (Figure 3).
Figure 3: Survival Data for DCVax®-Brain Patient population
Two-year survival Three-year survival
DCVax-Brain (n=19) 69% 47%
Stupp et al. 2005 (n=297) 26% 20%
Source: Northwest Biotherapeutics
Figures 4 and 5 show the Kaplan Meier Plots for DCVax®-Brain as of September, 2009, for progression-free survival and overall survival. The data is compelling: in the patients who received standard of care treatment, the tumour had quickly returned following the standard treatment (this occurs in nearly 100% of cases). In contrast, in the patients who received DCVax® in addition to standard treatment, the tumour did not return for over two years.
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