Key Developments: Ab Science SA (ABS.PA)

ABS.PA on Paris Stock Exchange

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Latest Key Developments (Source: Significant Developments)

AB Science announces positive preclinical results of studies on masitinib
Thursday, 30 Oct 2014 01:06pm EDT 

AB Science SA:Announces positive preclinical results of studies on masitinib.Findings showed that masitinib reduced stroke-related brain infarct size in animal model of stroke.Masitinib may be recommended as appropriate candidate for further development of novel neuroprotective strategies, including in acute ischemic stroke.  Full Article

AB Science DSMB recommends the continuation of phase 3 study of masitinib in progressive forms of multiple sclerosis
Monday, 6 Oct 2014 12:00pm EDT 

AB Science SA:Says the Data and Safety Monitoring Board (DSMB) recommends the continuation of the phase 3 study of masitinib in progressive forms of multiple sclerosis.Says results confirm there are no observed safety concerns with masitinib over a two-year treatment period.  Full Article

AB Science says DSMB recommends continuation of its phase 3 study of Masitinib in mastocytosis
Tuesday, 30 Sep 2014 11:49am EDT 

AB Science SA:Says external Data and Safety Monitoring Board (DSMB) has recommended continuation of its phase 3 study of Masitinib in mastocytosis.Says final analysis of trial data is still planned for 2015.  Full Article

AB Science announces publication of results from randomized phase 2 study of masitinib
Monday, 28 Jul 2014 02:01am EDT 

AB Science SA:Announces publication of results from randomized phase 2 study of masitinib in treatment of Gleevec-resistant gastrointestinal stromal tumor.Findings showed masitinib to produce statistically significant overall survival (OS) advantage of 12.4 months in patients with Gleevec-resistant GIST.Primary efficacy analysis ensured masitinib treatment arm could satisfy prespecified progression-free survival (PFS) threshold.Secondary efficacy analysis showed that masitinib followed by standard of care generated survival benefit over standard of care.International phase 3 trial of masitinib in patients with Gleevec-resistant/intolerant GIST has been initiated based on these promising results.  Full Article

AB Science proposes allocation of FY 2013 result and share repurchase program
Thursday, 22 May 2014 08:00pm EDT 

AB Science SA:To propose to annual general meeting on June 27 that loss made in FY 2013 (14,254,907 euros) be allocated to retained earnings account.Says that no dividend has been paid for last three fiscal years.To propose terms of share repurchase program to annual general meeting.Program would authorize repurchase of up to 10 pct of capital.Maximum price per share 36 euros.Total maximum that could be spent 25 million euros.Authorization valid for 18 months.  Full Article

AB Science announces negative opinion from CHMP on appeal for conditional authorization of Masitinib in pancreatic cancer
Thursday, 22 May 2014 02:04pm EDT 

AB Science SA:Says Committee for Medicinal Products for Human Use (CHMP) of European Medicine Agency (EMA) has adopted negative opinion on conditional marketing authorization for Masiviera (Masitinib mesylate) for first line treatment of non resectable locally advanced or metastatic pancreatic cancer.This decision is on appeal filed by AB Science following previous negative opinion adopted by the CHMP in January.Rapporteurs considered that evidence presented in pain and in genetic subgroups were promising, but that benefit was not sufficiently demonstrated since data were derived from subgroup analysis.Safety profile of masitinib did not raise serious issues in consideration of other more toxic alternatives used in pancreatic cancer.Majority of outstanding quality issues were resolved.However, in the absence of demonstrated benefit, CHMP considered that benefits of masitinib did not outweigh its risks at this stage of the development of masitinib.Phase 3 confirmatory study will be necessary to clearly demonstrate benefit of masitinib in target subgroups, which account for about 60 pct of pancreatic cancer patients.  Full Article

AB Science SA leaves SBF 120 Index and share price falls sharply-DJ
Friday, 21 Mar 2014 06:17am EDT 

AB Science SA:Leaves SBF 120 Index-DJ.Shares fall sharply on last day on index.  Full Article

AB Science SA announces CHMP negative opinion on appeal for conditional authorization of Masitinib in second-line treatment of GIST
Thursday, 20 Mar 2014 02:40pm EDT 

AB Science SA:Announces Committee for Medicinal Products for Human Use (CHMP) of European Medicine Agency (EMA) has adopted negative opinion on conditional marketing authorization for Masican (Masitinib mesylate) for treatment of malignant gastrointestinal stromal tumor (GIST) resistant to first-line treatment.Decision is on appeal filed by AB Science following previous negative opinion adopted by the CHMP in Nov. 2013.CHMP considered that study did not provide enough evidence to be confident that overall survival benefit was robust and that safety profile was sufficiently characterized.AB Science intends to file for marketing authorization with data from phase 3 confirmatory study that is currently recruiting patients in second-line treatment of GIST.  Full Article

AB Science SA initiates phase 3 study of masitinib in combination with docetaxel
Thursday, 20 Feb 2014 12:00pm EST 

AB Science SA:Announces the initiation of a phase 3 study to evaluate the safety and efficacy of masitinib in combination with docetaxel in first line treatment of metastatic Castrate Resistant Prostate Cancer (mCRPC).Says this international, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to compare masitinib in combination with docetaxel to placebo in combination with docetaxel in first line metastatic Castrate Resistant Prostate Cancer (mCRPC).Says the study will measure overall survival as a primary efficacy criterion.Says the phase 3 study has been authorized by competent authorities and will recruit 550 patients.  Full Article

AB Science SA announces negative opinion from CHMP for the conditional approval of Masitinib in the treatment of pancreatic cancer
Thursday, 23 Jan 2014 12:13pm EST 

AB Science SA:Says the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has adopted a negative opinion for the conditional approval of Masiviera (Masitinib mesylate) for the first-line treatment of non-resectable locally advanced or metastatic pancreatic cancer.Says the CHMP mentions three concerns.Says the CHMP's first concern is the failure of the study in the overall population and the need to confirm the benefit in the subgroups since according to CHMP the study was not designed to show benefit in these smaller groups.Says the CHMP's second concern is the increased toxicity of the combination of masitinib and gemcitabine as compared to gemcitabine alone.Says the CHMP also has concerns about the quality of the product, and in particular that patient exposure to impurities is insufficiently controlled and that the reproducibility between clinical and commercial batches cannot be guaranteed.Says it intends to appeal.Says first reason for the appeal is that the two subgroups where masitinib is efficient, patients with pain and patients with aggressive genomic biomarker represent an urgent need since the median survival is shorter than in the overall population.Says the second reason is that the findings in the two subgroups are consistent with the known action of masitinib able to boost and modulate the innate immune system.Says the appeal should lead the CHMP to deliver a second opinion in the course of 2014.  Full Article

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