Active Biotech's project ANYARA will be presented at the European Cancer Congress 2013

September 12, 2013 10:05 (CEST)

Detailed analysis further supports effect of ANYARA in a biomarker defined subgroup

LUND, Sweden, Sept. 12, 2013 (GLOBE NEWSWIRE) --

Active  Biotech  (NASDAQ OMX NORDIC: ACTI)
today  announced that  a biomarker  trend analysis  of overall survival (OS) and
Progression Free Survival (PFS) from the ANYARA Phase II/III study in renal cell
cancer  will be presented at the scientific conference "European Cancer Congress
2013" (ECCO-ESMO-ESTRO)  held  in  Amsterdam,  the  Netherlands,  September 27 -
October 1.

Professor  Tim Eisen, Department of Oncology, Cambridge University Hospitals NHS
Foundation  Trust,  UK,  will  present  "Baseline  biomarker trend analysis of a
randomized phase 2/3 study of naptumomab estafenatox plus IFN-alpha vs IFN-alpha
in advanced renal cell carcinoma *".

The  detailed analysis gives  further support to  the previous findings that low
baseline  levels of  pre-formed antibodies  against ANYARA  or low levels of the
cytokine  IL-6, independently predict anti-tumor efficacy after ANYARA+IFN-alpha
treatment. The results also highlight the potential role of IL-6 as a predictive
factor for the outcome of immunotherapy of cancer in general.

The  analysis showed  clear trends  of increased  OS (decreasing  Hazard Ratios,
"HR"s)  in  patients  with  decreasing  IL-6 and anti-ANYARA antibodies. Similar
trends were seen for PFS HRs.

For   more   detailed  information,  please  see   http://eccamsterdam2013.ecco-   The  presentation  will  be  available  on  Active Biotech's web site

* T. Eisen, G. Hedlund, G. Forsberg, Ö. Nordle, R. Hawkins.

The  Phase II/III study encompassed  513 patients from approximately 50 sites in
Europe  (UK, Ru, Uk, Bu,  Ro) and was designed  to evaluate the effect of ANYARA
(naptumomab  estafenatox)  in  combination  with interferon-alpha, compared with
interferon-alpha alone, in patients with advanced renal cell cancer. The primary
endpoint  was overall survival  (OS). Secondary endpoints  were Progression Free
Survival (PFS) and safety. The results were presented at ASCO in June 2013. High
baseline  levels of  pre-formed antibodies  against superantigens  were shown to
decrease ANYARA levels while the biomarker IL-6 was suggested to be a predictive
marker  for immune  therapies. Although  the study  did not  achieve its primary
endpoint  to show a prolonged OS in  the overall ITT population, the addition of
ANYARA  to interferon-alpha improves OS and PFS in a biomarker defined subgroup.
In  this subgroup,  patients with  high levels  of pre-formed antibodies against
superantigens  or  the  cytokine  IL-6 were  excluded.  In this subgroup of 130
patients,  the median OS for the ANYARA  vs. placebo treatment arm were 63.3 vs.
31.1 months (HR: 0.59; p=0.020), respectively. The median PFS were 13.7 (ANYARA)
vs. 5.8 (placebo) months (HR: 0.62; p=0.016).

ANYARA is a TTS (Tumor Targeting Superantigen) compound that makes the treatment
of  cancer tumor-specific. The development of  ANYARA is mainly focused on renal
cell  cancer. Positive data  was reported from  clinical Phase I  trials in lung
cancer,  renal cell cancer and pancreatic cancer. In July 2009, the results from
two  Phase  I  studies  of  ANYARA  were  published  in  the Journal of Clinical
Oncology,  where ANYARA was studied both as  a single agent (monotherapy) and in
combination  with  an  established  tumor  therapy  - docetaxel (Taxotere®) - in
patients with advanced cancer. The results showed that ANYARA was well tolerated
both  as monotherapy and in combination  with docetaxel. ANYARA has been granted
orphan-drug status by the EMA for the indication renal cell carcinoma.

Renal  Cell Carcinoma (RCC) affects  approximately 180,000 people worldwide each
year.  Approximately 50 %  of the  patients are  affected by  metastases. If the
disease  has metastasized, average survival is around 2 years. The survival rate
of  patients diagnosed  with renal  cancer is  only 5-15% after  five years. The
market  for treatment of  RCC is estimated  at approximately USD 2.7 billion per
year (EvaluatePharma March 2012).

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, tasquinimod
for prostate cancer and ANYARA primarily for the treatment of renal cell cancer.
In  addition, laquinimod is also in Phase  II development for Crohn's and Lupus.
The  company also has one additional project in clinical development, the orally
administered  compound paquinimod  (57-57) for systemic  sclerosis. Please visit for more information.

For further information:

Active Biotech

Tomas Leanderson, President & CEO
Tel: +46 46 19 20 95

Active Biotech AB (Corp. Reg. No. 556223-9227)
  Box 724, SE-220 07 Lund
  Tel: +46 46 19 20 00
  Fax: +46 46 19 11 00

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Market Act
This  press release  contains certain  forward-looking statements. Such forward-
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circumstances or changes in expectations after the date of this press release.

Active  Biotech is obligated to publish  the information contained in this press
release  in accordance with the Swedish  Securities Market Act. This information
was provided to the media for publication 10:00 am CET on September 12, 2013.

Active Biotech's project ANYARA will be presented at the European Canc: