Impact of Active Biotech's candidate drug tasquinimod on bone metastases presented at ASCO


     Tasquinimod Phase II retrospective follow-up study shows an impact of
                 tasquinimod on bone metastases as measured by
                             Bone Scan Index (BSI)

Lund  (Sweden),  June  3, 2013. Active  Biotech  (NASDAQ OMX NORDIC: ACTI) today
presented Phase II retrospective follow-up data from the prostate cancer project
with tasquinimod at the scientific conference "2013 ASCO Annual Meeting" held in
Chicago  (USA). This study was performed in collaboration with EXINI Diagnostics
AB (publ).

Today  Dr.  Andrew  J.  Armstrong  from  the  Duke Cancer Institute (Durham, NC)
presented  "Tasquinimod and  effects on  bone scan  index in men with metastatic
castration-resistant prostate cancer (mCRPC): results of retrospective follow up
of a randomized phase 2 placebo-controlled trial*".

Using  an  automated  software  for  analysis  of  the  bone scan index (BSI), a
quantitative measure of tumor burden in bone, the relation of the BSI with other
prognostic  biomarkers and overall survival were analyzed in a data set from the
previously concluded Phase II tasquinimod clinical study.

A  delay in objective radiographic bone  scan progression with tasquinimod using
the   BSI  analysis  was  observed,  and  this  delay  may  be  associated  with
improvements  in  survival.  In  an  analysis  of  all  patients,  regardless of
treatment  arm,  baseline  BSI  correlated  with  OS  (HR  1.42; p=0.013)  in  a
univariate  analysis. It  remained associated  with OS  (HR 1.64; p=<0.001) in a
multivariate  analysis including tasquinimod  treatment and different validated,
prognostic baseline factors.

"These  results show that  BSI can be  a valuable and  more objective radiologic
assessment  in  trials  of  men  with  metastatic  castration-resistant prostate
cancer,   and   is  clearly  associated  with  prognosis  and  disease  burden.
Tasquinimod had a favorable impact on the BSI over time, confirming our original
findings  in  the  randomized  phase  2 trial.   The ability to obtain objective
measures  of bone  metastases can  help fuel  drug development  in this disease,
where  current bone scan assessments are often misclassified and very subjective
",  says  principal  author  Andrew  Armstrong,  MD  ScM, Associate Professor of
Medicine  and Surgery  at the  Duke Cancer  Institute  and  a member of the Duke
Prostate Center.

Helén   Tuvesson,   CSO   Active   Biotech,   said:  "This  type  of  innovative
collaborations, utilizing novel technologies, may be most valuable in the future
development of tasquinimod".

For  more detailed  information, please  see www.asco.org.   The presentation is
available on Active Biotech's web site www.activebiotech.com.



*  A.J.  Armstrong,  R.  Kaboteh,  M.A.  Carducci,  J-E Damber, W.M. Stadler, M.
Hansen, L. Edenbrandt, G. Forsberg, Ö. Nordle, R. Pili, M.J. Morris.

About tasquinimod
Tasquinimod is a novel small molecule that targets the tumor microenvironment by
binding  to S100A9  and modulating  regulatory myeloid  cell functions, exerting
immunomodulatory,  anti-angiogenic  and  anti-metastatic properties. Tasquinimod
may  also suppress the tumor hypoxic response, contributing to its effect on the
tumor  microenvironment.  Today  the  development  of tasquinimod is principally
focused on the treatment of prostate cancer. Active Biotech and Ipsen (Euronext:
IPN;   ADR:   IPSEY)  have  a  broad  partnership  for  the  co-development  and
commercialization  of  tasquinimod.  Under  the  terms  of the agreement, Active
Biotech   has  granted  Ipsen  exclusive  rights  to  commercialize  tasquinimod
worldwide,  except for North  and South America  and Japan, where Active Biotech
has  retained  all  commercial  and  marketing rights. Both companies co-develop
tasquinimod for the treatment of castrate-resistant prostate cancer (CRPC), with
the possibility of developing tasquinimod in other cancer indications.

It  was announced  in December  2009 that the  primary endpoint  of the Phase II
clinical  study - which aimed  at showing a higher  fraction of patients with no
disease  progression during the six-month  period of treatment using tasquinimod
versus  placebo -- had been met. Phase  II results were published in the Journal
of  Clinical  Oncology  in  September  2011. The  results  showed  that  6 month
progression-free  proportions  for  TASQ  and  placebo groups were 69% and 37%,
respectively  (p<.0001). The median progression free survival was 7.6 months for
the tasquinimod group, compared to 3.3 months for the placebo group (p=0.0042).

Analysis  of up to three years safety data from the Phase II study, presented at
the  EAU February 2012, showed that treatment side effects were mild to moderate
(~  5% of  AEs  grade  3-4), manageable  and  less  frequent after two months of
therapy.  The  adverse  events  observed  included  gastrointestinal  disorders,
primarily observed initially during treatment, fatigue and musculoskeletal pain.

In June 2012, overall survival (OS) data was presented at ASCO (American Society
of Clinical Oncology).
In  October 2012, biomarker data were presented  at the scientific congress ESMO
(European  Society  for  Medical  Oncology).  The  results  support an effect of
tasquinimod  on both immunomodulation  and angiogenesis, positioning tasquinimod
as  a potentially  unique therapeutic  approach with  a mechanism of action that
does not target the androgen receptor pathway.

Also,  in April  2013, the independent  Data and  Safety Monitoring Board (DSMB)
monitoring  the ongoing Phase III trial  recommended that the study continues in
accordance with the protocol since no safety-related issues were noted.

A  new  Phase  II,  proof-of-concept  clinical  trial, was initiated and aims at
establishing  the  clinical  efficacy  of  tasquinimod  when used as maintenance
therapy  in  patients  with  mCRPC  who  have  not progressed after a first-line
docetaxel  based chemotherapy. Ipsen  has also initiated  an innovative Phase II
proof-of-concept  clinical trial  with tasquinimod,  to evaluate  the safety and
efficacy  of  tasquinimod  in  advanced  or metastatic hepato-cellular, ovarian,
renal cell and gastric carcinomas in patients who have progressed after standard
therapies.

About EXINI Diagnostics AB (publ)
EXINI  Diagnostics  AB  (publ)  offers  advanced  solutions for medical decision
support  to hospitals worldwide. The system  is based on advanced image analysis
by  artificial intelligence  and can  make its  own interpretation  of radiology
images  and provide diagnostic suggestions. In this  way the system is used as a
decision  support for the diagnosing doctor.  EXINI is working with products for
the  diagnosis of some  of the most  frequent endemic diseases  such as coronary
heart disease, cancer, dementia and Parkinson's disease. The company was founded
in 1999 by Professor Lars Edenbrandt. EXINI is listed on the stock market NASDAQ
OMX First North and has about 500 shareholders. Principal owner is Bo Håkansson.
Thenberg & Kinde Fondkomission AB acts as Certified Adviser.

About Active Biotech (publ)
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 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
www.activebiotech.com for more information.


For further information:

Active Biotech

Tomas Leanderson, President & CEO
Tel: +46 46 19 20 95
tomas.leanderson@activebiotech.com

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


Active Biotech's Safe Harbor Statement in Accordance with the Swedish Securities
Market Act
This  press release  contains certain  forward-looking statements. Such forward-
looking  statements  involve  known  and  unknown risks, uncertainties and other
important   factors   that  could  cause  the  actual  results,  performance  or
achievements  of the company, or industry results, to differ materially from any
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statements.  The company does not undertake any obligation to update or publicly
release   any   revisions  to  forward-looking  statements  to  reflect  events,
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 3:00 p.m. CET on June 3, 2013.

[HUG#1706571]

Pièces jointes

Impact of Active Biotech's candidate drug tasquinimod on bone metastas.pdf