ANYARA has been well tolerated by the patients. The maximum tolerated dose (MTD) has been determined to be 22 microgram per kilogram bodyweight.
The ANYARA phase I clinical dose escalation trial is ongoing at the Fox Chase Cancer Center in Philadelphia, USA, at the Norwegian Radium Hospital in Oslo, Norway and at Christie Hospital in Manchester, UK. A parallel trial, investigating the drug in combination with Taxotere®, is running concurrently at clinics in the USA, Denmark and Russia.
The results achieved to date fulfill the design criteria for ANYARA:
1) The dose is in the order of 200 times higher than that given with the first generation of ANYARA
2) This dose appears to be active in all patients as determined by immunological biomarkers
3) ANYARA is more convenient to administer to patients via injections instead of infusions
The dose limiting side effects were fever or hypotension, lasting for a few hours only and easily managed with standard medical interventions (anti-pyretics and fluids). Based on the mechanism of action, these side effects were according to expectations.
"The data generated in this study to date have fulfilled the objectives of determining an MTD and providing evidence of biological activity. Accrual to this study continues as we confirm the MTD and enroll sufficient numbers of patients at the MTD to collect preliminary information on efficacy, including survival, in a larger number of patients, says Dr. Roger Cohen at the Fox Chase Cancer Center in Philadelphia, USA.
As previously reported, patients treated with the first generation of ANYARA had a high frequency of stable disease and prolonged survival times. In the ongoing trial, efficacy data will be reported after patients in the ongoing study have had adequate follow-up.
In parallel to studying patient safety, additional important findings regarding the actions of ANYARA have been generated. These include a sustained level of the immunostimulatory cytokine Interleukin 2 (IL-2) after the second day of treatment. Such sustained levels of IL-2 correlated with prolonged survival in patients treated with the first generation of ANYARA.
Most patients treated so far with doses of ANYARA that are felt to be in the therapeutic range also have had similar sustained IL-2 levels.
Furthermore, a selective expansion of ANYARA reactive T lymphocytes after treatment serve as a 2nd biological marker, one that underscores ANYARA's selective immunostimulatory properties in patients with malignant disease.
As previously reported, ANYARA also effectively localizes to 5T4 positive tumors in cancer patients.
"Active Biotech's current candidate drug, ANYARA has a toxicity profile that is more favorable than predicted. It can be given at significantly higher doses than its predecessor with a manageable and limited spectrum of side-effects. To explore more fully its efficacy the ongoing phase I study will be expanded to a total of 50 patients. Knowing the MTD of ANYARA as a single agent will also accelerate parallel development of ANYARA in combination with various chemotherapy regimens. The available data strongly support the further development of ANYARA", says Sven Andréasson, President & CEO of Active Biotech.
Lund 15 December, 2005
Active Biotech AB (publ)
Sven Andréasson
President & CEO
For further information, please contact:
Sven Andréasson, President & CEO, tel: +46 46-19 20 49
Tomas Leanderson, Chief Scientific Officer, tel: +46 46-19 20 95
Cecilia Hofvander, Manager Corporate Communication, tel: +46 46-19 11 22
Active Biotech AB is a biotechnology company focusing on research and development of pharmaceuticals. Active Biotech has a strong R&D portfolio with pipeline products focused on autoimmune/inflammatory diseases and cancer. Most advanced projects are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, as well as ANYARA for use in cancer immunotherapy with the primary indication non-small cell lung cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer 57-57 for SLE and RhuDex® for RA.
Active Biotech AB
Box 724, SE-220 07 Lund
Tel: +46 46-19 20 00
Fax: +46 46-19 20 50
www.activebiotech.com