Active Biotech presents survival data on cancer drug


Forty-three renal cancer patients, included in a previously concluded multi-centre open label Phase II study (1) of Active Biotech's TTS CD2, were treated with individualized doses of TTS CD2. All patients were followed for survival and two year survival data have now been compiled.
As previously reported, TTS CD2 was well tolerated and the majority of adverse events were of moderate severity. Forty patients were evaluated with CT scan. At a four months follow-up analysis, one patient had a partial response lasting more than 11 months, while sixteen patients had stable disease. Before entering the study, most patients had progressed in their disease after at least one previous therapy.
However, survival was substantially longer than expected. Median survival for all the patients in the study was 19.7 months with thirteen patients still alive at date. Expected median survival according to Motzer prognostic factors (2,3) was 14.4 months. Twenty-two patients were included in a high dose group and twenty-one in a low dose group.

The group of patients with the highest drug exposure lived almost twice as long as expected, 26.6 months, compared to 15.1 months.
The low dose group lived approximately as long as expected, 12.1 months, compared to 13.0 months.

"These are extremely encouraging data. The number of patients is limited but the apparent dose-response with this first generation product, suggests that the TTS concept is very promising", says Professor Robert Hawkins, Principal Investigator, Christie Hospital in Manchester, UK.
"The approach of targeting bacterial superantigens to tumors using antibodies is intriguing and these results merit continued evaluation and the development of the next generation TTS product ANYARA", says Dr. Louis Weiner at the Fox Chase Cancer Center in Philadelphia, USA.
This survival data will be presented at the NCRI conference held in Birmingham, UK on October 2-5. There will also be a poster presentation: "A Phase II study of tumor-targeted superantigen (ABR-214936) recognizing the 5T4 oncofetal antigen in patients with advanced renal cell carcinoma". An oral presentation covering developments in immunotherapy will be made by the Principal Investigator Professor Robert Hawkins and will also include these results.
"Active Biotech's current candidate drug, ANYARA, has been designed to have an enhanced anti-tumor activity with lower general toxicity. It can be given at significantly higher doses than in this study, which is of importance for optimal efficacy. The data now presented makes us even more confident in our development of ANYARA", says Sven Andréasson, President & CEO of Active Biotech.
A phase I clinical dose escalation trial with ANYARA in high dosage is ongoing at the Fox Chase Cancer Center in Philadelphia, USA, at the Norwegian Radium Hospital in Oslo, Norway and at Christie Hospital, Manchester, UK.
Lund, September 29, 2005
Active Biotech AB (publ)
Sven Andréasson
President & CEO
1) - Press &News - Release archive 2003 12 17: Positive results
confirmed in final report for Active Biotech's TTS cancer product.
2) Motzer RJ et al., Prognostic factors for survival in previously treated patients with metastatic renal cell carcinoma. J Clin Oncol. 2004, 22:454-63.
3) Motzer RJ.Prognostic factors and clinical trials of new agents in patients with metastatic renal cell carcinoma. Crit Rev Oncol Hematol. 2003, 46 Suppl:S33-9.
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