Thu, Aug. 11, 5:54 AM
Thu, Feb. 18, 3:25 AM
- Active Biotech AB (OTC:ATVBF): Q4 EPS of -SEK0.45
- Revenue of SEK5M (+72.4% Y/Y)
Jun. 25, 2015, 10:03 AM
- Teva Pharmaceutical Industries (TEVA -0.1%) and co-developer Active Biotech (OTC:ATVBF) announce that patient enrollment is complete (n=2,199) in a Phase 3 study, called CONCERTO, evaluating laquinimod (0.6 mg/day or 1.2 mg/day) in patients with relapsing-remitting multiple sclerosis (RRMS) for up to 24 months. The primary endpoint is time to three-month confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS). Final data collection is projected to occur in May 2018. The study's completion date is June 2018. Regulatory filings will follow thereafter.
- The sample size of the trial will be re-assessed to confirm that the original assumptions related to completion remain valid. Per the Special Protocol Assessment (SPA) with the FDA, study completion will occur when either 260 events are reached or all patients complete 24 months of treatment. Assuming the former occurs first, then results could be available as soon as mid-2017.
- Laquinimod, a CNS-active immunomodulator, has had a rough ride on its road to approval. It has been in late-stage development for MS since late 2007. Earlier Phase 3 trials failed to demonstrate a significant reduction in relapses.
Apr. 16, 2015, 8:42 AM
- Swedish firm Active Biotech (OTC:ATVBF) and its French partner Ipsen (OTCPK:IPSEY) terminate their collaboration, inked in 2011, to co-develop and commercialize tasquinimod, a small molecule compound, for the treatment of prostate cancer. The companies decided to head for the exit after reviewing the top-line results from a 1,200-subject Phase 3 clinical trial (10TASQ10) that showed treatment with tasquinimod in patients with metastatic castration-resistant prostate cancer (mCRPC) did not extend overall survival.
- The efficacy results along with the preliminary safety data did not support a positive benefit/risk balance in mCRPC patients. Full results will be presented at a future scientific meeting.
Nov. 4, 2014, 10:23 AM
- Teva Pharmaceutical Industries (TEVA -0.6%) and Active Biotech (OTC:ATVBF) expand their clinical development of laquinimod with the initiation of a Phase 2 proof-of-concept clinical trial (ARPEGGIO) to evaluate the drug for the treatment of primary progressive multiple sclerosis (PPMS). The study will assess the efficacy of two doses (0.6 mg/day and 1.5 mg/day) versus placebo. The primary endpoint is brain atrophy as measured by percent brain volume change (PBVC) via MRI analysis from baseline to week 48. PPMS is characterized by worsening neurologic function without distinct relapses.
- Additionally, Teva has screened the first patient in another Phase 2 trial (LEGATO-HD) that will assess laquinimod for the treatment of Huntington's disease. The primary endpoint is the change from baseline after 12 months of treatment as measured by UHDRS-TMS.
Jun. 12, 2013, 8:22 AM
Teva's (TEVA -1.8%) and Active Biotech's (ATVBF.PK) oral laquinimod drug improved renal function in patients with active lupus nephritis in Phase IIa trials. Lupus is a chronic and often disabling autoimmune disease that can lead to kidney failure. Teva and Active Biotech believe the data provide the rationale for further studies of laquinimod. (PR)| Jun. 12, 2013, 8:22 AM | 1 Comment
Mar. 21, 2013, 8:21 AM
Teva (TEVA +0.25%) and Active Biotech (ATVBF.PK) say that early treatment of Multiple Sclerosis with their Laquinimod drug significantly cuts the risk of disability progression in patients, a Phase III trial shows. Additional data from an animal preclinical study demonstrates that laquinimod can restore myelination in the brain and spinal cord. (PR)| Mar. 21, 2013, 8:21 AM | 3 Comments
Oct. 22, 2012, 10:14 AM
Laquinimod, which is being developed by Teva (TEVA +1.2%) and Sweden's Active Biotech, performed well in a Phase IIa trial of patients with moderate to severe Crohns disease. The drug had a "robust, early and consistent effect on remission" and on response rates compared with a placebo. Laquinimod was also well-tolerated. (PR)| Oct. 22, 2012, 10:14 AM
Aug. 8, 2012, 9:41 AM
Teva (TEVA) and Active Biotech are set to initiate the third Phase III trial of their oral Laquinimod treatment for relapsing remitting multiple sclerosis. Two previous trials have produced positive results. Teva also nominates former Bank Leumi CEO Galia Maor as a director.| Aug. 8, 2012, 9:41 AM | 3 Comments
Dec. 9, 2010, 8:37 AM