LUND, SWEDEN--(Marketwire - January 23, 2012) -
A Phase I Investigator sponsored clinical
trial, led by Principal Investigator Dr.Andrew Armstrong at Duke
University
Hospital, US, has been announced for Active Biotech's (NASDAQ OMX Nordic: ACTI)
prostate cancer project TASQ. The primary objective for the CATCH
trial
(Cabazitaxel (Jevtana) And Tasquinimod in Men with Castration-Resistant
Heavily
pre-treated Prostate Cancer) is to determine the recommended dose of
TASQ in
combination with cabazitaxel based on safety and tolerability in men
with
chemorefractory metastatic castration-resistant prostate cancer
(CRPC).
Secondary objectives include efficacy as measured by progression free
survival,
and overall survival. The study will include about 30 CRPC patients. For
further
information about the study, please see www.clinicaltrials.gov..
Given previous significant activity observed with both TASQ and taxane
chemotherapy in CRPC, there is a strong rationale for the study of the
combined
use of these agents. In preclinical model systems of castrate-resistant
prostate
cancer, TASQ combined with taxane-based chemotherapy has been shown to
further
delay tumor progression.
A global, pivotal, randomized, double-blind, placebo-controlled Phase III
study
of TASQ in patients with metastatic CRPC is ongoing. The aim of the study
is to
confirm TASQ's effect on the disease, with radiological PFS as the
primary
endpoint and overall survival as secondary endpoint. The study will
include
about 1,200 patients in more than 250 clinics.
Active Biotech AB (publ)
Tomas Leanderson
President & CEO
Notes to editors
About TASQ
The development of TASQ is principally focused on the treatment
ofprostate
cancer. TASQ is an antiangiogenic compound, meaning that it cuts off the
supply
of nutrients to the tumor. Studies have concluded that TASQ exhibits anti-
tumor
activity via inhibition of tumor angiogenesis. It was announced in
December
2009 that the primary endpoint of the Phase II clinical study, to show a
higher
fraction of patients with no disease progression during the six-month
period of
treatment using TASQ, had been met. Final Phase II results were
published in
Journal of Clinical Oncology in September 2011. It was concluded that
TASQ
significantly slowed disease progression and improved Progression Free
Survival
(PFS) in patients with metastatic castrate-resistant prostate cancer
(CRPC),
alongside an acceptable side effect profile. Six month progression
free
proportion of patients for TASQ and placebo treatment groups were 69% and
37%,
respectively (p < 0.0001), with a median PFS of 7.6 vs. 3.3 months (p =
0.0042).
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, TASQ for prostate
cancer and
ANYARA for use in cancer targeted therapy, primarily of renal cell
cancer. In
addition, laquinimod is in Phase II development for Crohn's and Lupus.
Further
projects in clinical development comprise the two orally administered
compounds,
57- 57 for Systemic Sclerosis as well as RhuDex™ for RA. Please
visit
www.activebiotech.com for more information.
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 is required under the Securities Markets Act to make the
information in this press release public.
The information was submitted for publication at 08:30 a.m. CET on January
23, 2012.
Active Biotech's Prostate Cancer Project TASQ in Phase I Combination :
http://hugin.info/1002/R/1579256/492756.pdf
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Source: Active Biotech via Thomson Reuters ONE
[HUG#1579256]