The US Food and Drug Administration approved the IND application for the commencement of clinical trials in January 2003.
Cancer specialists at the Fox Chase Cancer Center in Philadelphia and at the Radiumhospitalet in Oslo will be participating in the study. The principal investigator for the study is professor Roger B Cohen in Philadelphia. As in previous Phase I trials with TTS CD2, patients with non small-cell lung cancer will be treated. A recently completed follow-up of the Phase I trials of TTS CD2 (www.activebiotech.com - press&news April 23, 2003) showed that the survival for the majority of the treated patients was longer than one could expect from the normal progression of the disease.
"The initiation of Phase I clinical trials of CD3 is an important step in the TTS program. Already with CD2, we were able to demonstrate promising results with regard to the survival of patients with non small-cell lung cancer. With CD3, we expect to be able to give higher doses and thus further reinforce the anti-tumor effect,"
says professor Tomas Leanderson, Chief Scientific Officer at Active Biotech.
The goal of the Phase I study is to determine the maximum tolerable dose (MTD) that can safely be given to humans and to define possible side effects.
It is planned that the study will comprise a total of 30 patients.
Today, non small-cell lung cancer is primarily treated with chemotherapy and surgery. There is an extensive need for new treatment methods, since available therapies do not provide 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 with the highest mortality rate. NSCLC affects close to a million people worldwide each year. There are no effective treatment methods.
Lund, May 8, 2003
Active Biotech AB (publ)
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