LUND, SWEDEN--(Marketwired - Jun 3, 2013) - Active Biotech (NASDAQ OMX NORDIC: ACTI)
presented Phase II retrospective follow-up data from the prostate cancer
with tasquinimod at the scientific conference "2013 ASCO Annual Meeting"
Chicago (USA). This study was performed in collaboration with EXINI
Today Dr. Andrew J. Armstrong from the Duke Cancer Institute
presented "Tasquinimod and effects on bone scan index in men with
castration-resistant prostate cancer (mCRPC): results of retrospective
of a randomized phase 2 placebo-controlled trial*".
Using an automated software for analysis of the bone scan index
quantitative measure of tumor burden in bone, the relation of the BSI with
prognostic biomarkers and overall survival were analyzed in a data set
previously concluded Phase II tasquinimod clinical study.
A delay in objective radiographic bone scan progression with tasquinimod
the BSI analysis was observed, and this delay may be associated
improvements in survival. In an analysis of all patients,
treatment arm, baseline BSI correlated with OS (HR 1.42; p=0.013)
univariate analysis. It remained associated with OS (HR 1.64; p=<0.001)
multivariate analysis including tasquinimod treatment and different
prognostic baseline factors.
"These results show that BSI can be a valuable and more objective
assessment in trials of men with metastatic castration-resistant
cancer, and is clearly associated with prognosis and disease
Tasquinimod had a favorable impact on the BSI over time, confirming our
findings in the randomized phase 2 trial. The ability to obtain
measures of bone metastases can help fuel drug development in this
where current bone scan assessments are often misclassified and very
", says principal author Andrew Armstrong, MD ScM, Associate
Medicine and Surgery at the Duke Cancer Institute and a member of the
Helén Tuvesson, CSO Active Biotech, said: "This type of
collaborations, utilizing novel technologies, may be most valuable in the
development of tasquinimod".
For more detailed information, please see www.asco.org. The
available on Active Biotech's web site www.activebiotech.com.
* A.J. Armstrong, R. Kaboteh, M.A. Carducci, J-E Damber, W.M.
Hansen, L. Edenbrandt, G. Forsberg, O. Nordle, R. Pili, M.J. Morris.
Tasquinimod is a novel small molecule that targets the tumor
binding to S100A9 and modulating regulatory myeloid cell functions,
immunomodulatory, anti-angiogenic and anti-metastatic properties.
may also suppress the tumor hypoxic response, contributing to its effect
tumor microenvironment. Today the development of tasquinimod is
focused on the treatment of prostate cancer. Active Biotech and Ipsen
(Euronext: IPN; ADR: IPSEY) have a broad partnership for the co-development
commercialization of tasquinimod. Under the terms of the agreement,
Biotech has granted Ipsen exclusive rights to commercialize
worldwide, except for North and South America and Japan, where Active
has retained all commercial and marketing rights. Both companies co-
tasquinimod for the treatment of castrate-resistant prostate cancer (CRPC),
the possibility of developing tasquinimod in other cancer indications.
It was announced in December 2009 that the primary endpoint of the
clinical study - which aimed at showing a higher fraction of patients
disease progression during the six-month period of treatment using
versus placebo -- had been met. Phase II results were published in the
of Clinical Oncology in September 2011. The results showed that 6
progression-free proportions for TASQ and placebo groups were 69% and
respectively (p<.0001). The median progression free survival was 7.6
the tasquinimod group, compared to 3.3 months for the placebo group
Analysis of up to three years safety data from the Phase II study,
the EAU February 2012, showed that treatment side effects were mild to
(~ 5% of AEs grade 3-4), manageable and less frequent after two
therapy. The adverse events observed included gastrointestinal
primarily observed initially during treatment, fatigue and musculoskeletal
In June 2012, overall survival (OS) data was presented at ASCO (American
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
monitoring the ongoing Phase III trial recommended that the study
accordance with the protocol since no safety-related issues were noted.
A new Phase II, proof-of-concept clinical trial, was initiated and
establishing the clinical efficacy of tasquinimod when used as
therapy in patients with mCRPC who have not progressed after a
docetaxel based chemotherapy. Ipsen has also initiated an innovative
proof-of-concept clinical trial with tasquinimod, to evaluate the
efficacy of tasquinimod in advanced or metastatic hepato-cellular,
renal cell and gastric carcinomas in patients who have progressed after
About EXINI Diagnostics AB (publ)
EXINI Diagnostics AB (publ) offers advanced solutions for medical
support to hospitals worldwide. The system is based on advanced image
by artificial intelligence and can make its own interpretation of
images and provide diagnostic suggestions. In this way the system is used
decision support for the diagnosing doctor. EXINI is working with
the diagnosis of some of the most frequent endemic diseases such as
heart disease, cancer, dementia and Parkinson's disease. The company was
in 1999 by Professor Lars Edenbrandt. EXINI is listed on the stock market
OMX First North and has about 500 shareholders. Principal owner is Bo
Thenberg & Kinde Fondkomission AB acts as Certified Adviser.
About Active Biotech (publ)
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company
focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal
are laquinimod, an orally administered small molecule with
immunomodulatory properties for the treatment of multiple sclerosis,
for prostate cancer and ANYARA primarily for the treatment of renal cell
In addition, laquinimod is in Phase II development for Crohn's and
company also has one additional project in clinical development, the
administered compound paquinimod (57-57) for systemic sclerosis. Please
www.activebiotech.com for more information.
Active Biotech's Safe Harbor Statement in Accordance with the Swedish
This press release contains certain forward-looking statements. Such
looking statements involve known and unknown risks, uncertainties and
important factors that could cause the actual results,
achievements of the company, or industry results, to differ materially
future results, performance or achievement implied by the forward-
statements. The company does not undertake any obligation to update or
release any revisions to forward-looking statements to reflect
circumstances or changes in expectations after the date of this press
Active Biotech is obligated to publish the information contained in this
release in accordance with the Swedish Securities Market Act. This
was provided to the media for publication 3:00 p.m. CET on June 3, 2013.
Impact of Active Biotech?s candidate drug tasquinimod on bone metastas:
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Source: Active Biotech via Thomson Reuters ONE