Active Biotech: Information regarding the clinical study LEGATO-HD
11 January 2016 - 6:30PM
Lund, January 11,
2016 - Active Biotech (Nasdaq Stockholm: ACTI) today announces
that its partner Teva Pharmaceutical Industries Ltd, will amend the
trial design in a Phase 2 study of laquinimod in Huntington's
disease. The amendment consists of dropping the highest of three
doses (1.5 mg/day) in the trial while keeping two remaining active
doses (0.5 and
1 mg/day) unchanged. This is a precautionary measure in the
interest of patient safety being suggested by Teva to the Data
Safety Monitory Board (DSMB) for the LEGATO-HD trial.
The DSMB accepted the
recommendation after reviewing data which observed cardiovascular
incidents in patients receiving the high doses of laquinimod in two
multiple sclerosis trials as reported on January 4, 2016. No
cardiovascular events have been observed for any dose of the
LEGATO-HD trial. Teva will continue in its commitment to study
laquinimod in Huntington's disease.
Currently the mechanism of the
cardiovascular events in the MS trials remains unknown. Although no
specific time-to-event patterns have been identified,
cardiovascular risk factors and demographics may play a role.
For further information, please
contact:
Tomas Leanderson, President & CEO
Tel +46 46 19 20 95
Hans Kolam, CFO
Tel +46 46 19 20 44
Active Biotech AB
PO Box 724, SE-220 07 Lund
Sweden
Tel: +46 (0)46-19 20 00
Fax: +46 (0)46-19 11 00
Active Biotech AB (publ) (Nasdaq
Stockholm: ACTI) is a biotechnology company with focus on
neurodegenerative/inflammatory diseases and cancer. Laquinimod, an
orally administered small molecule with unique immunomodulatory
properties, is in pivotal Phase 3 development for the treatment of
relapsing remitting multiple sclerosis. Also, laquinimod is in
Phase 2 development for the treatment of primary progressive
multiple sclerosis and Huntington's disease. Furthermore,
commercial activities are conducted for the ISI, ANYARA and
paquinimod projects. Please visit www.activebiotech.com for more
information.
Active Biotech is obligated to publish the
information contained in this press release in accordance with the
Swedish Securities Market Act and/or the Financial Instruments
Trading Act. This information was provided to the media for
publication at 8:30 am CET on January 11, 2016.
Information regarding the clinical
study LEGATO-HD
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Active Biotech via Globenewswire
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