LUND, Sweden, March, 9, 2007-Active Biotech (ACTI.ST), today announced new positive clinical data from the Phase Ib study of TASQ, for the treatment of prostate cancer.
By step-wise dose escalation, a safe dose of 1 mg/day of TASQ was achieved, which corresponds to a doubling of the previously reported maximum tolerated dose (MTD) level of 0.5 mg/day. This means that a step-wise intra-patient dose-escalation enables a dose of 1 mg/day to be administered in future clinical trials.
"These new results confirm and reinforce earlier results obtained at a lower dose level. We now have a very complete data set that constitute a solid base to move into Phase II clinical trials", said Sven Andréasson, President and CEO of Active Biotech.
The ongoing 10-week study comprises patients with so called hormone-refractory prostate cancer. This is an advanced stage of prostate cancer where the tumor cells no longer respond to hormone treatment. All patients entering the study had rising serum levels of Prostate Specific Antigen (PSA), which is a surrogate marker for tumor progression.
PSA measurements were recorded and PSA velocity (PSAV) was calculated after 28 days of treatment. Five out of six patients had a >50% decrease in PSA velocity compared to prior treatment. Three of these five patients exhibited a decrease in absolute PSA levels.
The study is being performed at the urological clinics at the University Hospitals in Lund, Malmö and Uppsala, Sweden.
The objective of the TASQ project is to develop a pharmaceutical product that can be administered orally for the long-term treatment of prostate cancer. Phase II studies are scheduled to start during 2007. The Medical Products Agency has approved on the new MTD to be used in the continued clinical program of TASQ.
The pharmaceutical market for prostate cancer is estimated at more than USD 3 billion a year. Prostat e cancer is the most common form of cancer among men. The incidence is strongly age-related and is unusual before age 50. In 2006, 2.2 million new cases were estimated to have been diagnosed in the US alone.
Lund, March 9, 2007
Active Biotech AB (publ) Sven Andréasson President and CEO
For further information, please contact: Sven Andréasson, President and 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 targeted therapy, the primary indication being renal 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. In addition, the preclinical development of the I-3D project is being conducted in cooperation with Chelsea Therapeutics.
Active Biotech AB (org.nr 556223-9227) P.O. Box 724, SE-220 07 Lund, Sweden Tel +46 46-19 20 00 Fax +46 46-19 20 50