Key Developments: Ab Science SA (ABS.PA)

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Latest Key Developments (Source: Significant Developments)

AB Science SA Announces Positive Results of Amyothropic Lateral Sclerosis Efficacy Experiments with Masitinib
Wednesday, 6 Nov 2013 01:00pm EST 

AB Science SA announced that the acceleration of the clinical development program in Amyothropic Lateral Sclerosis (ALS) is in line with proof of efficacy experiments with masitinib, conducted in two different models that generated positive results of increased survival. One experiment was aimed at evaluation the effect of masitinib in mice models of ALS. Administration of masitinib significantly delayed age of symptoms onset, improved grip strength and weight loss compared to control animals. Other experiment was aimed at evaluating the effect of masitinib in a transgenic rat model of ALS. Compared to control, masitinib prolonged the survival of ALS rats, delaying the progression of paralytic symptoms and weight loss, suggesting a protective effect of masitinib in motor neuron diseases.  Full Article

AB Science SA Announces Transformation of Masitinib in Treatment of Amyotrophic Lateral Sclerosis Study from Phase 2 into Phase 3
Monday, 4 Nov 2013 12:03pm EST 

AB Science SA announced the initiation of a clinical development program with masitinib in the treatment of Amyotrophic Lateral Sclerosis (ALS). The clinical development program of masitinib in ALS started with a phase 2 clinical study, which involved the recruitment of 45 patients. Health authorities agreed to transform the phase 2 study into phase 3, with prospective recruitment of 210 patients. The readout of this study is expected by the end of 2015. This study is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).  Full Article

AB Science SA to Receive EUR 5.9 Million Subsidy as Leader of Consortium Created for Development of New Alzheimer's Disease Therapy
Tuesday, 23 Jul 2013 02:46am EDT 

AB Science SA announced the creation of a partnership in the development of a new targeted therapy in Alzheimer's disease. The consortium will receive EUR 8.6 million from Bpifrance, the French state innovation agency, within the framework of the Industrial Strategic Innovation (ISI) program, and gathers together ABScience, the Brain and Spine Institute (ICM), MIRCen from the Atomic Energy Commission (CEA), the National Institute of Health and Medical Research (INSERM), Imagine Foundation and Skuldtech, a biotechnology company specialized in the discovery of biomarkers and development of diagnostic and testing tools companions. AB Science SA, initiator and leader of this project entitled ROMANE (Role of Mast Cells in Neurology), will receive a total amount of EUR 5.9 million from Bpifrance in the form of grants and repayable advances.  Full Article

AB Science SA Issues Two Convertible Bonds for a Total Amount of EUR 12.5 Million
Monday, 10 Jun 2013 01:00pm EDT 

AB Science SA announced that it issued to existing shareholders two bond loan agreements, convertible or repayable in ordinary shares, for the nominal amount of EUR 12,508,268 in a private arrangement. The amount of these bonds has been fully subscribed and issued. The bonds bear 0.00% or 0.25% interest to be paid annually, representing for the four bond loans an average annual interest rate of 0.18%. They also bear 2.50% accrued interest to be paid only in case of repayment of the loan in cash. The bonds are convertible into shares at any time at the initiative of the bondholder at the price of EUR 23.53 or EUR 29.30 per share, i.e. an average price of EUR 24.38 per share for both bond loans. The bonds may be repaid by anticipation in cash at the option of AB Science under certain conditions. They will be repayable in full on the seventh anniversary of the issue date at their nominal value. If so, the conversion of the bonds will represent the issuance of a maximum of 516,104 ordinary shares, representing a maximum dilution of 1.6%.  Full Article

AB Science SA Announces Launch of a Phase 3 Clinical Trial in Alzheimer's Disease
Monday, 20 May 2013 11:35am EDT 

AB Science SA announced the launch of a phase 3 clinical trial in the treatment of Alzheimer's disease with masitinib, as well as the recruitment of the first patients in this study in several countries. This is an international, multicenter, randomized (1:1:1 ratio), double-blind, placebo controlled, three parallel group phase 3 study to compare the efficacy and safety of masitinib at two different doses in the treatment of patients with mild to moderate Alzheimer's disease. This study, for which recruitment has started in Europe and other countries, will enroll approximately 400 patients.  Full Article

AB Science SA and Skuldtech Announce the Identification of New Predictive Markers for Pancreatic Cancer Survival Associated with Masitinib Treatment
Monday, 5 Nov 2012 02:30am EST 

AB Science SA and Skuldtech announced the discovery of a new set of blood markers predictive of a higher survival rate in pancreatic cancer patients. Skuldtech and AB Science SA plan to exploit these new markers for commercialization of a future companion test associated with masitinib, a molecule developed by AB Science SA for treating pancreatic cancer. Based on Skuldtech’s technological approach associating gene sequencing with the company’s bioinformatics tools and gene profiling studies (transcriptome), these findings were made during a phase III clinical trial focusing on pancreatic cancer and managed by AB Science SA. The purpose of the phase III study was to evaluate the therapeutic efficiency of a new treatment combining masitinib and gemcitabine as compared with the current standard pancreatic cancer treatment of gemcitabine only. From a simple drop of blood, Skuldtech and AB Science SA were able to identify specific markers – transcriptomic markers – that can distinguish between the different populations treated during the phase III study and select the predictive markers for pancreatic cancer survival associated with masitinib treatment.  Full Article

AB Science SA Reports Phase Three Study Results of Masitinib in Combination with Gemzar for Treatment of Pancreatic Cancer
Tuesday, 30 Oct 2012 02:40pm EDT 

AB Science SA (AB Science) announced on October 30, 2012 the results from a phase three study evaluating the effect of masitinib in combination with Gemzar on overall survival (OS) in patients with pancreatic cancer. Briefly, masitinib in combination with Gemzar extended median OS by six and 2.7 months in two independent patient populations, representing 65% and 45% of the overall population; namely, patients with a genetic biomarker - collected from simple blood sample - indicative of aggressive disease progression, and patients with cancer pain. Pain intensity and the discovered genetic biomarker were shown to be of prognostic value for survival under Gemzar alone and at the same time predictive of increased survival with masitinib in combination with Gemzar for those patients identified as having a poor prognosis with Gemzar alone. AB Science also announced that the European Medicines Agency (EMA) has accepted to review a Marketing Authorization Application (MAA) for conditional approval of masitinib in combination with Gemzar in the treatment of pancreatic cancer, following filing of this dossier.  Full Article

AB Science SA Announces that European Medicines Agency Accepts Marketing Application for Masitinib in the Treatment of Gleevec resistant Gastro-Intestinal Stromal Tumor
Thursday, 4 Oct 2012 11:42am EDT 

AB Science SA announced that the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for masitinib in the treatment of patients with Gleevec-resistant gastro-intestinal stromal tumors (GIST). Filing for the Marketing Authorization of masitinib in GIST resistant to Gleevec was accepted by EMA on the basis of results from a phase II study that showed masitinib to improve overall survival in patients with Gleevec-resistant GIST as compared with Sutent (sunitinib) from Pfizer, which is currently the standard of care for second-line treatment of GIST.  Full Article

AB Science loses appeal over EU rejection of cancer drug

LONDON - French biotech company AB Science has lost an appeal to get the London-based European Medicines Agency to reconsider its rejection of the company's cancer drug Masican, originally handed down in November.

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