CONCERTO and ARPEGGIO Trials Continue Study of Lower-dose Laquinimod
JERUSALEM, Israel & LUND, Sweden I January 4, 2016 I Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Active Biotech (NASDAQ Stockholm:ACTI) today announced the discontinuation of higher doses of laquinimod in two ongoing studies in multiple sclerosis after the occurrence of cardiovascular events, none of which was fatal, in eight patients.
The change comes at the recommendation of the data monitoring committee (DMC) overseeing two active clinical studies in MS. The DMC identified an imbalance in the number of cardiovascular events in the studies. Seven events were observed in patients receiving laquinimod daily at 1.2mg for treatment of relapsing-remitting MS (RRMS) in the CONCERTO trial. No events occurred in the 0.6mg or placebo groups. CONCERTO has 2,199 patients with 3,070 years of patient experience. One event was observed in the 1.5mg daily-dose arm of the ARPEGGIO trial in primary-progressive MS (PPMS). ARPEGGIO has enrolled 191 patients and has 35 years of patient experience. Teva is notifying trial sites to discontinue the higher doses immediately in both trials and will encourage participants to continue follow ups.
Both trials, CONCERTO and ARPEGGIO, are continuing the lower-dose arms (0.6mg daily), and participants in the trials will be provided with an update to confirm re-consent for participation. The DMC did not identify a cardiovascular signal with the lower dose but recommended long-term monitoring. Teva has completed large trials and is conducting long-term extension studies at the 0.6mg dose currently without cardiovascular concerns.
Through a licensing agreement, Teva has global rights to develop and commercialize laquinimod, a small-molecule entity discovered by Active Biotech.
About Laquinimod
Laquinimod is a once-daily oral, investigational, CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of relapsing-remitting MS (RRMS), primary-progressive MS (PPMS) and Huntington disease.
Details about clinical trials with laquinimod can be found at clinicaltrials.gov. Trials mentioned in this release and the clinicaltrials.gov reference number follow:
- CONCERTO (RRMS) — NCT01707992
- ARPEGGIO (PPMS ) — NCT02284568
- ALLEGRO extension (RRMS) – NCT00988052
- BRAVO extension (RRMS) – NCT01047319
- LAQ/5063-OL (RRMS) – NCT00745615
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva’s net revenues in 2014 amounted to $20.3 billion. For more information, visit www.tevapharm.com.
About Active Biotech
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 III development for the treatment of relapsing-remitting multiple sclerosis. Also, laquinimod is in phase II development for the treatment of primary-progressive multiple sclerosis and Huntington disease. Furthermore, commercial activities are ongoing for the projects ISI, ANYARA and paquinimod. Please visit www.activebiotech.com for more information.
SOURCE: Teva Pharmaceutical Industries
Post Views: 84
CONCERTO and ARPEGGIO Trials Continue Study of Lower-dose Laquinimod
JERUSALEM, Israel & LUND, Sweden I January 4, 2016 I Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Active Biotech (NASDAQ Stockholm:ACTI) today announced the discontinuation of higher doses of laquinimod in two ongoing studies in multiple sclerosis after the occurrence of cardiovascular events, none of which was fatal, in eight patients.
The change comes at the recommendation of the data monitoring committee (DMC) overseeing two active clinical studies in MS. The DMC identified an imbalance in the number of cardiovascular events in the studies. Seven events were observed in patients receiving laquinimod daily at 1.2mg for treatment of relapsing-remitting MS (RRMS) in the CONCERTO trial. No events occurred in the 0.6mg or placebo groups. CONCERTO has 2,199 patients with 3,070 years of patient experience. One event was observed in the 1.5mg daily-dose arm of the ARPEGGIO trial in primary-progressive MS (PPMS). ARPEGGIO has enrolled 191 patients and has 35 years of patient experience. Teva is notifying trial sites to discontinue the higher doses immediately in both trials and will encourage participants to continue follow ups.
Both trials, CONCERTO and ARPEGGIO, are continuing the lower-dose arms (0.6mg daily), and participants in the trials will be provided with an update to confirm re-consent for participation. The DMC did not identify a cardiovascular signal with the lower dose but recommended long-term monitoring. Teva has completed large trials and is conducting long-term extension studies at the 0.6mg dose currently without cardiovascular concerns.
Through a licensing agreement, Teva has global rights to develop and commercialize laquinimod, a small-molecule entity discovered by Active Biotech.
About Laquinimod
Laquinimod is a once-daily oral, investigational, CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of relapsing-remitting MS (RRMS), primary-progressive MS (PPMS) and Huntington disease.
Details about clinical trials with laquinimod can be found at clinicaltrials.gov. Trials mentioned in this release and the clinicaltrials.gov reference number follow:
- CONCERTO (RRMS) — NCT01707992
- ARPEGGIO (PPMS ) — NCT02284568
- ALLEGRO extension (RRMS) – NCT00988052
- BRAVO extension (RRMS) – NCT01047319
- LAQ/5063-OL (RRMS) – NCT00745615
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva’s net revenues in 2014 amounted to $20.3 billion. For more information, visit www.tevapharm.com.
About Active Biotech
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 III development for the treatment of relapsing-remitting multiple sclerosis. Also, laquinimod is in phase II development for the treatment of primary-progressive multiple sclerosis and Huntington disease. Furthermore, commercial activities are ongoing for the projects ISI, ANYARA and paquinimod. Please visit www.activebiotech.com for more information.
SOURCE: Teva Pharmaceutical Industries
Post Views: 84
