Active Biotech's Cancer Project ANYARA Featured in Journal of Clinical OncologyJuly 28, 2009 08:30 (CEST)
Two parallel Phase I studies1) were performed, one monotherapy study (including 39 patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC) or renal cell cancer (RCC)) with ANYARA and one study in combination with docetaxel (13 patients with NSCLC), in order to assess the safety, tolerability and pharmacology of ANYARA.
The results showed that ANYARA was well tolerated both as monotherapy and in combination with docetaxel.
ANYARA showed immunological activity including systemic increase in inflammatory cytokines, selective expansion of ANYARA reactive T-cells and induction of tumor infiltrating T-cells. Anti-tumor activity was assessed and in the mono study fourteen patients (36%) had Stable Disease (SD) after two months. In the combo study the best overall response was confirmed Partial Response (a tumor reduction of at least 30 percent), for 2 patients (15%) and SD for 5 patients (38%).
ANYARA is presently in development primarily for the treatment of renal cell cancer. A pivotal phase III study, which has completed enrollment of over 500 patients, is currently ongoing.
Active Biotech AB (publ)
President & CEO
1) Previously presented in summary in press releases: December 13, 2006 "Active Biotech's Novel Cancer Treatment ANYARA Shows Pharmacological Proof of Concept after Successful Phase I Studies" and October 24, 2007 "Active Biotech's Cancer Project ANYARA Proven Safe in Combination with Taxotere®", now detailed in JCO.
For further information, please contact
Tomas Leanderson, President & CEO
Tel: +46 46 19 20 95
Göran Forsberg, VP IR & Business Development
Tel: +46 46 19 11 54
Notes to editors
ANYARA is a TTS (Tumor Targeting Superantigens) compound that makes the treatment of cancer tumor-specific. The development of ANYARA is mainly focused on renal cell cancer. Positive data was reported in connection with the interim analysis in Phase II/III and from clinical Phase I trials in lung cancer, renal cell cancer and pancreatic cancer. The median survival of 26.2 months observed for patients with advanced renal cancer and treated with ANYARA is twice the expected length. ANYARA has been granted orphan-drug status by the EMEA for the indication renal cancer. Information concerning the ongoing clinical trial is available at www.activebiotech.com and www.clinicaltrials.gov.
About Active Biotech
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase 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, primarily of renal cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer, 57-57 for SLE and RhuDex(TM) for RA. Please visit www.activebiotech.com for more information.
Active Biotech AB
PO Box 724, SE-220 07 Lund
Tel: +46 (0)46-19 20 00
Fax: +46 (0)46-19 11 00
Active Biotech is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 08:30 am CET on July 28, 2009.