Impact of Active Biotech's candidate drug tasquinimod on bone metastases presented at ASCO
(Thomson Reuters ONE) -
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(at)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
future results, performance or achievement implied by the forward-looking
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.
Impact of Active Biotech?s candidate drug tasquinimod on bone metastas:
http://hugin.info/1002/R/1706571/564940.pdf
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originality of the information contained therein.
Source: Active Biotech via Thomson Reuters ONE
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