The primary endpoint was defined as the number of responders to treatment. 19 patients started TTS CD2 treatment and after 2 months 5 (26%) of the patients showed stable disease (SD). Four of the patients still showed SD 4 months after start of TTS treatment. Median survival time was 148 days.
Of the total number of pancreatic cancer patients included in the study, all 19 had previously received other treatment for pancreatic cancer, 18 (95%) had received prior chemotherapy and 17 (89%) had received chemotherapy with gemcitabine. The relatively high frequency of patients with stable disease (SD) in the study indicates a biological activity of the TTS compound. Furthermore, the TTS products possess a unique, immune-mediated mode of action with few and mild side effects.
"Pancreatic cancer is one of the most difficult cancers to treat. Since the patients included in this trial had advanced disease and had almost all been pre-treated with gemcitabine, a median survival time of 148 days is encouraging - the median survival of patients treated with first line therapy on the pivotal trial with gemcitabine was 170 days",
says Professor Robert Hawkins, Principal Investigator, Christie Hospital in Manchester, UK.
"Our study also shows that TTS is well tolerated by the patients and treatment of this very severe type of cancer is feasible", concludes Professor Hawkins.
Background:
Cancer of the exocrine pancreas continues to be a major unresolved health problem, with approximately 27000 deaths per year in the United States and 50000 deaths per year in Europe (excluding the former USSR). The difficulties in diagnosis, the aggressiveness of pancreatic cancer, and the lack of effective systemic therapies mean that only 1% to 4% of patients with adenocarcinoma of the pancreas will be alive five years after diagnosis. Thus, incidence rates are virtually identical to mortality rates.
Lund, March 25, 2004
Active Biotech AB (publ)
Sven Andréasson
President & CEO
For further information about Active Biotech visit www.activebiotech.com.
Active Biotech AB is a biotechnology company focusing on research in and development of pharmaceuticals. Active Biotech has a strong R&D portfolio and pipeline products with focus primarily on autoimmune/ inflammatory diseases and cancer. Most advanced projects include orally administered small molecules with unique immunomodulatory properties that can be used to treat autoimmune and inflammatory diseases, as well as a novel concept for use in cancer immunotherapy.
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