Skuldtech and AB Science announce the identification of new predictive markers for pancreatic cancer survival associated with masitinib treatment

Sat Nov 3, 2012 12:08pm EDT

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Skuldtech and AB Science announce the identification of new predictive markers for pancreatic cancer survival associated with masitinib treatment

Discovered during a phase III clinical trial investigating the therapeutic efficiency of AB Science’s masitinib, these newly-discovered biological markers will pave the way for market authorization of a companion diagnostic test associated with this drug. The test developed by Skuldtech will identify patients most likely to benefit from this new treatment

Regulatory News:

Skuldtech, a genomic and pharmacogenomic company specialized in developing diagnostic tests, and AB Science (NYSE Euronext – FR0010557264 – AB), a pharmaceutical company specialized in developing tyrosine kinase inhibitors, announce the discovery of a new set of blood markers predictive of a higher survival rate in pancreatic cancer patients. Skuldtech and AB Science plan to exploit these new markers for commercialization of a future companion test associated with masitinib, a molecule developed by AB science for treating pancreatic cancer.

Based on Skuldtech’s technological approach associating gene sequencing with the company’s proprietary 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. 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 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.

Developed based on these predictive markers for survival, this diagnostic tool is of significant interest to clinicians as they will be able to characterize from a simple blood sample which patients are the most likely to benefit from this treatment. Established using highly specialized diagnostic tests, patient stratification could be integrated into future solutions by healthcare systems, which will have the benefit of managing treatment costs more effectively.

These predictive markers for survival associated with masitinib treatment and identified in this phase III clinical trial are the joint property of AB Science and Skuldtech. Patents have been filed to protect the markers, which are also associated with the masitinib Marketing Authorization Application already filed with regulatory authorities by AB Science. When masitinib obtains market authorization for treating pancreatic cancer, AB Science will retain 100% of the rights related to masitinib.

To the best of our knowledge, this is the first time that new biological markers have been discovered during a phase III clinical trial. These markers are both specific to the drug being developed and associated with positive patient response,” said Didier Ritter, CEO, Skuldtech. “Faced with the “patent cliff” and a challenging economic context, the pharmaceutical industry is seeking new solutions for achieving successful phase III clinical trials, and also new vectors for growth. The concept of personalized medicine or personalization of treatments therefore represents a source of hope both for patients and the medical industry.

About pancreatic cancer

Pancreatic cancer is an aggressive cancer with poor prognosis. The survival rate after 5 years is only 5%. The incidence of this cancer represents about 110,000 new cases per year in industrialized countries. Today, diagnostics are performed using imaging and biological tests from biopsies. Gemcitabine is the main treatment at this time. The median overall survival time is 6.9 months.

About masitinib and AB Science

Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells, important cells for immunity, as well as a limited number of kinases that play key roles in various cancers. Through its activity of inhibiting certain kinases that are essential in some oncogenic processes, masitinib may have an effect on tumor regression, alone or in combination with chemotherapy.

Masitinib received Orphan Drug designation in the treatment of pancreatic cancer from both the FDA and EMA (European Medicines Agency). Masitinib is a molecule developed by AB Science, a pharmaceutical company specializing in the research, development and commercialization of new therapies targeting the unmet medical needs of patients with cancer and other serious diseases, including inflammatory diseases and central nervous system diseases.

For more information: www.ab-science.com

About Skuldtech

Skuldtech is an innovative biotechnology company specialized in the discovery of new biological markers and the development of new diagnostic tests. Biomarkers identified and selected by the company's scientific team are derived from its technology platform. The technology platform associates high-throughput sequencing, quantitative RT-PCR, and proprietary bioinformatics and biostatistics programs and is the result of 13 years of development and technical expertise in analyzing gene expression. Leveraging its unique scientific expertise analyzing gene expression in blood cells and whole blood, Skuldtech focuses personalized medicine and the development of companion and patient stratification tests to meet the increasing need for new treatments that are better adapted to patient profiles. Founded in 1999, Skuldtech is located at the Montpellier Biopôle campus in Montpellier, France. The company is a member of the Euromediag/Eurobiomed, Cancéropole Grand Sud Ouest (Cancer Centre of Southwest France) and Biomeridies clusters.

For more information: www.skuldtech.com

Media and analyst contacts
Skuldtech
info@skuldtech.com
or
AB Science
Laurent GUY, +33 1 4720 0014
investors@ab-science.com

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