GenoSafe : GLP certification

Evry, September 16th, 2008 – GenoSafe® SAS (the Genopole Evry-based service company specializing in evaluation of the safety and efficacy of innovative biotherapeutic products) has just obtained good laboratory practice (GLP) certification from the French Agency for Healthcare Products Safety (AFSSAPS)
An essential guarantee of quality and safety
The principles behind GLP constitute an organisational framework that covers all aspects of the planning and execution of non-clinical safety trials. Ever since GenoSafe's incorporation, customer-initiated preclinical studies have represented an ever-increasing proportion of the company's business. Following the inspection of GenoSafe's installations and an audit of its studies, the AFSSAPS has awarded the company with a GLP compliance certificate. GenoSafe obtained "A grade" compliance from the French regulatory authority in the "drugs for human use" category. GLP certification is a significant step forward for GenoSafe and will enable it to provide its customers with an internationally acknowledged guarantee of the quality, reproducibility and integrity of the regulatory data that the company generates. The certification will help GenoSafe meet its customers' needs and should attract new business in the field of GLP-compliant product safety evaluation...
... GenoSafe: From the initial steps in lab research to clinical trials, GenoSafe (a biotech company based on the Genopole Evry biopark, just south of Paris) has unique expertise in the development, validation and implementation of analytical methods for evaluating the safety and efficacy of biotherapeutic products such as gene and cell therapy products, vaccines, recombinan proteins and monoclonal antibodies. GenoSafe provides advice and project support to its customers (biotech firms, pharmaceutical companies, academic labs and research institutes) by offering them a broad range of services in complementary fields: molecular analysis (personalized qPCR, RT-qPCR and biodistribution studies), immunomonitoring, the quality control of viral vector batches and the creation and verification of custom cell lines... [PDF] GenoSafe's Press Release - PDF du Communiqué de Presse GenoSafe -

BMSystems and CEA life Sciences : patent application covering new therapeutic strategies and preclinical evaluation platform in psychiatric disorders

Paris, France, September 25, 2008 – The utilization of CADI™ (biological modeling approach and technologies) leads to a new industrial success in CNS diseases. BMSystems filed on Septembers 10, 2008, with CEA life Sciences, a patent application covering new therapeutic strategies and a preclinical evaluation platform in the field of psychiatric disorders.
This shared patent illustrates the unique efficacy of BMSystems’ proprietary CADI™ technologies, the excellence of the respective research teams and the successful application of the collaborative CADI™ four steps validation process.
After the successful launch and financing, in 2006, of its spin-off Pherecydes-Pharma (infectious diseases, 2 patents), Bio-Modeling Systems confirms the power of its business strategy to create immediate value through collaborations with partners...
...About the Company:
BMSYSTEMS is an independent research-based biotech company that creates CADI™ models of biological systems (pathologies, embryology, bacterial metabolism, etc.) to generate businesses with immediate applications... [PDF] Bio-Modeling Systems' Press Release -

About GENOMIC VISION

GENOMIC VISION develops novel diagnostic and drug discovery solutions based on its world-leading nanotechnology for DNA analysis in the areas of cancer and acute diseases. These diagnostic tests and drug discovery tools operate where genome dynamics and human disease intersect. GENOMIC VISION uses a powerful technique, Molecular Combing Technology, for the direct visualization of single DNA molecules to detect quantitative and qualitative changes in the genome landscape and establish their contribution to pathology.

GENOMIC VISION initial focus is towards early cancer detection and drug therapy monitoring. The company possesses an unrivalled capability for discovering genomic biomarkers implicated in the predisposition and development of many forms of cancer and in following and analyzing DNA replication during cell division. This provides a unique approach for evaluating the efficacy of new drugs on the cell cycle... GENOMIC VISION's Company Profile -

Magnisense : MIAplex, a unique magnetic technology to detect multiple biological agents simultaneously

Paris, May 20, 2008 —Magnisense, a diagnostics company that develops and markets magnetic immunoassays, announces MIAplex™, a new magnetic bead technology that allows simultaneous multiparametric testing of biological samples, delivering improved speed and cost-performance ratios.

MIAplex™ builds on Magnisense’s MIAtek™, a robust and versatile detection technology making possible the development of magnetic immunoassays using magnetic beads as labels for monoparametric testing. It differs from Magnisense’s existing offer and competing technology by allowing the simultaneous use of several magnetic beads with varying magnetic properties for labeling several parameters in one sample – without the need for spatial resolution of key parameters. No other company worldwide offers such ability.

MIAplex™ has wide-ranging application potential, including medical and veterinary diagnostics, food inspection, environmental and security monitoring. The MIAplex™ approach is especially suited to biosensing of samples with practically unlimited volume. It can be used for example for testing drugs of abuse in drivers or occupational medicine, for infectious agents in blood, or for bacteria in foodstuffs...

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About Magnisense

Magnisense develops and markets magnetic immunoassays. These next-generation bioassays improve rapid diagnostic performance for human and animal diagnostics, food safety and environmental protection testing. They are based on magnetic bead markers, which can be used to achieve the accuracy of laboratory testing with the ease of use of rapid test methods.

Exploiting a unique feature of magnetic bead markers, Magnisense’s MIAtek™ technology provides true quantification of a large volume sample. The magnetic signal is free of interference from environmental factors, permitting a more sensitive and reproducible detection than possible with other surface-restricted approaches common in lateral flow rapid testing.

Magnisense is developing two test formats for different application areas:
MIAstrip™: Point of care testing with a single dose, producing objective, quantifiable and traceable results via a portable reader. MIAstrip enables the identification of a target via detection of known markers for a number of diseases including avian flu, cardiac disease, tetanus, and bacterial, viral, parasitic or mycotic infections.
MIAflo™: Disposable cartridges for detection of targets, such as bacterial contamination in food products, e.g. Listeria and Salmonella, or in water, e.g. Legionella, with a sensitivity that brings a significant reduction in testing time... Magnisense's Press Release - Communiqué de Presse Magnisense -

MAT Biopharma : completion of enrollment for Ferritarg

Evry, France, September 11 2008 - MAT Biopharma announced the completion of enrollment in the Phase I/II clinical trial for Ferritarg® in patients with relapsed or refractory Hodgkin’s disease. The objective of this study is to assess the safety and determine the MTD. Results from this study are expected in Q4 08 and MAT Biopharma projects to initiate the pivotal phase III in 2009...
...About MAT Biopharma.
MAT Biopharma is a privately held biopharmaceutical company focused on the development and commercialization of antibody based therapeutics for the treatment of haematological cancers and some solid tumors... [PDF] MAT Biopharma's Press Release -

CERENIS THERAPEUTICS : PHASE I CLINICAL TRIAL OF CER-002 FOR TREATMENT OF CARDIOVASCULAR DISEASE

Ann Arbor, Michigan & Toulouse, France, May 15, 2008—Cerenis Therapeutics SA (Cerenis), a privately held pharmaceutical company developing HDL-related compounds for the treatment of cardiovascular and metabolic diseases, announced that it has completed a Phase I clinical trial for CER-002, one of the company’s lead product candidates. CER-002 is a peroxisome proliferator-activated receptor (PPAR) delta specific agonist in development for the treatment of cardiovascular diseases.

CER-002 is the most advanced small molecule HDL candidate in Cerenis' portfolio. It was developed from new chemical entities that are specific agonists for human PPAR delta, a multifaceted therapeutic target with broad potential for the treatment of cardiovascular and metabolic diseases. In preclinical models, CER-002 has demonstrated strong efficacy in elevating HDL and in halting the progression of atherosclerosis. It was selected for clinical development from a series of small molecule compounds available to Cerenis through a licensing agreement with Nippon Chemiphar Co., Ltd....

...About Cerenis Therapeutics

Cerenis Therapeutics is a pharmaceutical company focused on the discovery, development and commercialization of breakthrough HDL-related therapies for the treatment of cardiovascular and metabolic diseases. Based on pioneering research conducted by the Cerenis team of world leaders in HDL therapy, the company is pursuing a range of HDL product candidates that are positioned to represent major advances in patient care and significant commercial opportunities in the treatment of cardiovascular and metabolic diseases. Cerenis has operations in Ann Arbor, Michigan and Toulouse, France.

Cerenis Therapeutics' Press Release -

Biomnis : Laboratory Pathology Handbook

April 7 2008 - Biomnis presents the Medical Pathology Handbook.The first edition of a reference work on medical pathology.
Major advances in medical pathology have contributed to the remarkable development of medicine in recent years. The number of tests available has continually increased, as has their complexity.
Pathologists are daily confronted not only with the need for precise measurements (which necessitates an understanding of the sensitivity and specificity of the technique being used) but also an appreciation of their relevance and how to interpret the results in terms of the disease in question. This means understanding current physiological knowledge and the relevant pathology...
...About Biomnis
The leading French specialised medical pathology laboratory which resulted from the merger of Marcel Mérieux and LCL, Biomnis has more than 1,000 employees in France and performs nearly 40,000 tests a day, including highly specialised procedures for which it has all the required accreditations.... Biomnis' Press Releases - Communiqués de Presse Biomnis -