Primary endpoint reached in Active Biotech's TASQ Phase II clinical trial in prostate cancer patients


Lund, Sweden, December 14, 2009 - A first analysis of the primary
endpoint based on data from at least six months' treatment of more
than 200 patients, has been performed in Active Biotech AB's (NASDAQ
OMX Nordic: ACTI) ongoing Phase II clinical study of TASQ, in
patients with asymptomatic, castrate resistant, metastatic prostate
cancer.

In this  analysis,  safety,  efficacy  and  certain  biomarkers  were
evaluated. The primary endpoint, to  show a difference in the  number
of patients with disease progression at six months, was reached.  The
fraction of patients  with disease progression  during the six  month
period was
43 % for  patients treated  with TASQ compared  to 67  % for  placebo
treated patients. The median progression free survival was 24.7 weeks
for the  TASQ group,  compared  to 12.9  weeks  (p=0.0001)   for  the
placebo group. TASQ treatment also  had a positive effect on  several
biomarkers relevant for prostate cancer progression and was generally
well  tolerated.  No  safety  concerns  significantly  affecting  the
risk/benefit ratio for TASQ were identified.

"This is a very important milestone for TASQ and Active Biotech. I am
looking  forward   to  the   further  development   of  this   novel,
non-cytotoxic treatment.  ",  says Professor  Tomas  Leanderson,  CEO
Active Biotech ".

The  top  line  data  are  based  on  the  local  review  of  disease
progression and an  additional central review  is currently  ongoing.
Complete results from the trial including additional details and data
from the central review will  be presented at an upcoming  scientific
conference and in scientific publications.

Lund, December 14, 2009
Active Biotech AB (publ)

Tomas Leanderson
President and CEO

For further information, please contact:

Göran Forsberg
VP Investor Relations & Business Development
Tel +46 (0)46-19 11 54
goran.forsberg@activebiotech.com







To editors

About TASQ
The development  of TASQ  is primarily  focused on  the treatment  of
prostate cancer. TASQ is a  small molecule from the quinoline  family
of compounds  that binds  to  the target  molecule S100A9.  TASQ  has
anti-angiogenic properties, meaning  that it cuts  off the supply  of
nutrients to the tumor but it does not belong to the most  frequently
occurring group  of tyrosine  kinase inhibitors.  The dosing  is  one
tablet a day.

Results from a Phase I trial  of TASQ were recently published in  the
British Journal of Cancer,  where TASQ was  studied in patients  with
castrate resistant prostate cancer. The results showed that long-term
continuous oral administration of TASQ seems to be safe and that TASQ
might delay disease progression.


About the Phase II trial
The reported clinical trial is a 2:1 randomized, placebo  controlled,
double-blind  Phase  II   trial  investigating  1   mg/day  of   TASQ
(tasquinimod, ABR-215050) versus placebo in 206 asymptomatic patients
with metastatic, castrate  resistant, prostate cancer.  The trial  is
conducted in the US, Canada and Sweden under an IND  (Investigational
New Drug) application.

The primary  endpoint  of  the  Phase II  trial  is  to  measure  the
proportion of  patients that  display disease  progression after  six
months of  TASQ  therapy compared  with  placebo. For  more  detailed
information please see http://clinicaltrials.gov. Secondary  clinical
endpoints  of  importance   for  this  group   of  patients   include
progression  free  survival,  safety   and  effects  on   biomarkers.
Documentation of  such endpoints  is of  importance for  future  TASQ
development and registration.

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 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  on
December 14, 2009 at 08:30 a.m.

Active Biotech AB
PO Box 724, SE-220 07 Lund
Sweden
Tel: +46 (0)46-19 20 00
Fax: +46 (0)46-19 11 00
www.activebiotech.com

Anhänge

Primary endpoint reached in Active Biotechs TASQ Phase II clinical trial.pdf
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