CORRECTION: Active Biotech: Information regarding the clinical study LEGATO-HD
January 11 2016 - 2:58AM
This is a correction of the announcement from 08:30 11.01.2016 CET.
Reason for the correction: Swedish version only that is
corrected
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 & CEOTel +46 46 19 20 95
Hans Kolam, CFOTel +46 46 19 20 44
Active Biotech ABPO 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
http://hugin.info/1002/R/1977862/724228.pdf
HUG#1977862
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