Impact of Active Biotech's candidate drug tasquinimod on bone metastases presented at ASCOJune 3, 2013 15:00 (CEST)
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".
* 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.
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:
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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