MYOSIX : Afssaps Authorization

2 Sept 2008 - MYOSIX is please to announce that the French Agency for Therapeutic Product (Afssaps) certified its cell therapy laboratory as an authorized center to prepare Cell Therapy Product for clinical use.
About MYOSIX:
Myosix dedicates its strong expertise in muscle cell technology to the development of cell-based therapies for diseases with unmet medical needs, such as myopathies. Myosix has developed an innovative technique for culturing adult skeletal muscle cells. This unique technique generates very large quantities of muscle precursor cells (myoblasts) from a small muscular biopsy sample... MYOSIX' Press Releases -

Immutep : IMP321 IND Allowance in Pancreatic Cancer

Orsay, October 16, 2008 - Immutep S.A. announced that the FDA, after review of the Investigational New Drug Application (IND), has allowed the administration of IMP321 in cancer patients in a Phase I trial conducted by Dr. William G. Hawkins at the Washington University School of Medicine in Saint Louis (MO).
IMP321 is a first-in-class immunopotentiator that agonizes MHC class II molecules thereby stimulating antigen-presenting cells (APC), such as dendritic cells and monocytes, leading to markedly improved cytotoxic CD8 T cells responses against tumours in patients with metastatic kidney or breast cancer. More than 500 s.c. injections have been administered to date at doses up to 30 mg.
The phase I study is an open-label, two-arm, dose escalation trial in advanced pancreatic cancer treated by first-line gemcitabine alone or associated with increasing doses of IMP321. Investigators will assess the safety and tolerability of this new chemo-immunotherapy combination protocol. The other points to be studied include IMP321's pharmacokinetics, pharmacodynamics and immunogenicity, as well as the exploration of the molecule's mechanism of action. IMP321 will be given s.c. q14 for a 6-month period the day after gemcitabine injection, with an option for additional months of therapy if disease improvement or stabilization is observed. The first two dose levels will be 3 and 6.5 mg followed by 13 and 26 mg if safety at higher doses is confirmed. At least 27 patients are expected to be enrolled...
...Immutep S.A.
Immutep S.A. is a biopharmaceutical company developing immunostimulatory factors for the treatment of cancer and chronic infectious diseases and immunomodulatory therapeutic antibodies for the treatment of cancer or autoimmune disease. The Company's technologies are based on the LAG-3 immune control mechanism that mediates T cell immune responses... Immutep's Press Release -

Imagine Eyes : mirao™ 52-e for retinal imaging and vision science applications

Orsay France, September 3, 2008 – After unveiling the prototype at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), Imagine Eyes is proud to announce that mirao™ 52-e Electromagnetic Deformable Mirror is now commercially available. This latest evolution of the award winning mirao product line follows on the success of the mirao 52-d by offering users several important new hardware and software features that make integrating and using the device even easier than before.

Key enhancements include:

• USB2 connectivity
• Space saving design
• Improved temporal behavior
• All-new Application Programming Interface
• Trigger output signal for TTL device synchronization

Perhaps the most easily visible improvement is that mirao 52-e’s electronic driver unit has been totally redesigned. The unit’s new compact size, half that of its predecessor and now one of the smallest on the market, incorporates several important enhancements and, even more, is fully plug-and-play compatible via a standard USB2 interface. On the software front, mirao 52-e is delivered with an all-new Application Programming Interface (API) that was painstakingly developed to provide easy access to mirao’s powerful wavefront correction abilities and ensure backwards compatibility as the product continues to evolve. Of course, mirao 52-e is CE marked and conforms to international electromagnetic and electrical safety standards... Imagine Eyes' Press Release -

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 -