Sixty-seven (67) patients were included in a survival study performed as a follow-up on patients participating in Phase I clinical studies of the TTS product CD2. In these Phase I studies, which were conducted in the USA and Europe 1998-2000, NSCLC patients were treated with different doses of TTS to define the side effects and the maximum tolerable dose (MTD). The trials achieved their objectives and showed promising results (for further information, please visit www.activebiotech.com - press&news, June 26, 2001). It is these patients that now have now been followed up in a separate survival study.
The median survival time in this study was 8.1 months, which is fully comparable to treatments currently on the market. Of the patients in the study, twenty-five per cent of the patients lived for 17.4 months or longer. The one-year survival rate was 43% and the two-year survival rate was 12%. The survival time for patients with NSCLC is highly dependent on the disease status. The patients in Active Biotech's studies belong to the groups designated advanced NSCLC stages III and IV. The evaluation includes all patients, independent of whether they have recieved the optimal dose or not.
The TTS product has a unique, immune-mediated mode of action with fewer side effects than conventional treatments with cytotoxic drugs and radiation. A large proportion of the patients in these Phase I studies had undergone at least one course of a cytotoxic treatment to which they were no longer responding, and thus had a poor prognosis.
Professor Steinar Aamdal of the Radium Hospital in Oslo, who was responsible for the European study, is enthusiastic about the results of the follow-up study: "This is a totally new method for treating lung cancer. Many patients were stabilised in their progressive disease and even though only a few patients responded with a tumour reduction, the results show a surprisingly long survival time for these patients, for whom the survival time is normally short."
Today, non small-cell lung cancer is primarily treated using cytotoxic drugs and surgery. There is a high medical need for new treatment methods, since the available therapies do not produce satisfactory results.
Background:
Non small-cell lung cancer (NSCLC) is one of the most commonly occurring malignant diseases. It is also the form of cancer that shows the highest mortality. NSCLC affects nearly half a million persons world-wide each year. There are no effective treatment methods.
Lund, April 23, 2003
Active Biotech AB
Sven Andréasson
President & CEO
For further information about Active Biotech visit http://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 (SAIK), as well as a novel concept for use in cancer immunotherapy (TTS).
Active Biotech AB
Box 724, SE-220 07 Lund, Sweden
Tel: +46 (0)46-19 20 00
Fax: +46 (0)46-19 20 50
E-mail info@activebiotech.com