Protea Biosciences and Mayoly-Spindler : Human Clinical Trial for New Biopharmaceutical

June 22, 2010 - Protea Biosciences, Inc., a leading developer of new technology for pharmaceutical research, announced that the company, in partnership with Mayoly-Spindler, a European pharmaceutical company, has commenced a Phase I/IIA human clinical trial for a new recombinant Lipase.

The clinical trial will be conducted at the Hospital "la Timone" in Marseilles, France. The goal of the clinical trial is to demonstrate safety and proof-of-concept data for the recombinant lipase as treatment for chronic pancreatitis.


Lipase is an enzyme that is produced by the pancreas to digest fat. Chronic pancreatitis is defined as long term inflammation of the pancreas, characterized by irreversible changes in pancreatic cells. This chronic inflammation can lead to chronic abdominal pain and/or impairment of hormone and digestive enzyme functions of the pancreas, and can produce serious weight loss. A lack of digestive enzymes made by the pancreas, results in the inability to properly digest food and absorb nutrients, resulting in malnutrition. Vitamin absorption (A, D, E, and K) is impaired.The main clinical symptoms are fat malabsorption known as steatorrhea, diarrhea, weight loss, abdominal discomfort and abdominal swelling...

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...Laboratoires Mayoly-Spindler is a privately-owned French pharmaceutical company, founded in 1929, essentially focused on gastroenterology... [PDF] Protea Biosciences' Press Release -

Rhenovia's Epilepsy Program for the Optimization of Antiepileptic Drug Discovery & Development of Pharmaceutical and Biotechnology Companies

2 June 2010 - Official Launch of Rhenovia's Epilepsy Program for the Optimization of Antiepileptic Drug Discovery & Development of Pharmaceutical and Biotechnology Companies...

...official launch of a collaborative project - cluster RHENEPI "Platform of neuronal modeling for the discovery and validation of drug treatments for Epilepsy"

This three-year project, of a total budget of 2.5 million euros, labeled cluster of Drug Innovation Alsace Bio Valley and competitiveness cluster Lyon Biopôle was obtained under the 9th call for projects launched by the Directorate General Competitiveness of Industry and Services of the French Ministry of Economy, Industry and Employment for funding from the Single Interministerial Fund (FUI).
The project RHENEPI lead by Rhenovia Pharma brings together four partners: two industrial partners, Rhenovia, a biotechnology company located in Mulhouse and SynapCell, a biotech company from Grenoble, and two academic partners: the research team of Dr. Antoine Depaulis Grenoble Neurosciences Institute (GIN) and Dr. Laurent Fagni, Institute of Functional Genomics (IGF) in Montpellier... Rhenovia Pharma's News -

Rhenovia Pharma's General Presentation

Rhenovia Pharma is a new R&D pharmaceutical and biotechnology company created on May 3, 2007.
It is headquartered at Mulhouse, 20c rue de chemnitz, France.
It has been founded by an international team highly committed to find new solutions to treat Alzheimer's disease (AD) and other diseases of the nervous system (NS).
Rhenovia has the legal form of an SAS. At present, it is funded by the founders, the team and business angels.
Core Activity: Biosimulation for brain diseases
Biosimulation consists in the use of computational models that provide a dynamic and quantitative description of a number of biological, pathological, and pharmacokinetic processes in order to understand complex biological processes. Biosimulation is particularly appropriate for use in CNS disease research. Unmet medical needs in this field, especially for Alzheimer's disease, are mostly due to the fact that all brain pathologies are extremely complex, multifactorial and dynamic... Rhenovia Pharma's General Presentation -


About SynapCell

SynapCell is a preclinical Contract Research Organization which provides translational solutions to evaluate the therapeutic potential of CNS drug candidates in epilepsy. SynapCell provides customized solutions which cover the entire range of customers needs, from early steps to the final answer... SynapCell company -

Transgene : exclusive option agreement for the development and commercialisation of its immunotherapy product TG4010 (presentation)

Parc d’Innovation d’Illkirch, France, March 10, 2010 – Transgene S.A. (Euronext Paris: FR0005175080) announced the signing of an exclusive option agreement with Novartis for the development and commercialisation of Transgene’s targeted immunotherapy product, TG4010 (MVA-MUC1-IL2), for the first-line treatment of non-small cell lung cancer (NSCLC) and other potential cancer indications.
Pursuant to the agreement, Transgene has granted Novartis an option to acquire an exclusive worldwide license for TG4010 and Novartis will pay Transgene a $10 million non-refundable option fee. Contingent upon the exercise of the option by Novartis and the achievement of successful development, regulatory and commercial milestones in various indications, Transgene is eligible to receive up to a total of approximately €700 million.
According to the agreement, Transgene will initially fund and retain control over the next clinical development phase of TG4010, which is a pivotal, global phase IIb/III clinical trial that Transgene currently anticipates starting by the end of 2010. This study will involve approximately 1,000 patients with MUC1-positive NSCLC who have normal levels of activated Natural Killer (NK) cells at time of trial entry1. The final results are expected to become available by the end of 2013...

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...About Transgene
Transgene is a France-based biopharmaceutical company dedicated to the development of
therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases.
The company has three compounds in phase II trials (TG4001/R3484, TG4010 and TG1042)
and two compounds in phase I studies (TG4040 and TG4023)... [PDF] Transgene's Press Release - PDF du communiqué de presse de Transgene -

Stentys' drug-eluting self-expanding stent : CE Marking

PRINCETON, N.J., and PARIS, May 24, 2010 — Stentys announced that it has received CE Marking for its drug-eluting self-expanding stent.
The unique self-expanding Stentys stent is designed to ensure optimal apposition of a stent in the critical initial hours and days after an AMI (acute myocardial infarction) procedure, by being continuously applied to the vessel‟s internal wall even during thrombus resolution and vessel spasm relief—thereby avoiding malapposition, a major predictor of stent thrombosis...

...About Stentys
Based in Princeton, N.J., and Paris, Stentys intends to make treatment of complex blocked coronary arteries as simple and effective as a conventional stenting procedure. The Company announced in December 2009 that it has started enrolling patients in the randomized APPOSITION II clinical trial to compare the Stentys self expanding stent against conventional stents in treating AMI patients, looking specifically at stent apposition and adaptation to vessel growth... [PDF] Stentys' Press Release -

IntegraGen : publication of the Results of a Study Assessing the Impact of a Combined Analysis of Four Genetic Variants on Autism Risk

Evry, France, April 13, 2010 - IntegraGen SA, a French biotechnology company dedicated to gene discovery, announced the publication of the results of a collaborative study reporting the use of a combined analysis of multiple genetic variants in a genetic score to help identify individuals at high risk of developing autism.
The study, entitled “Assessing the Impact of a Combined Analysis of Four Common Low-risk Genetic Variants on Autism Risk” appears in Molecular Autism, a peer-reviewed journal that publishes research on the molecular basis of autism and related neurodevelopmental conditions.
Based on an analysis of samples from two separate genetic sample collections which included over 450 families and nearly 1,000 children affected by autism, the authors report that the accumulation of multiple risk alleles in a genetic score is a useful strategy for assessing the risk of autism in children who have older siblings affected by autism. The authors suggest that this approach may be better than studying single polymorphisms for identifying subgroups of individuals with significantly greater risk of autism...

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...About IntegraGen
IntegraGen is a biotechnology company dedicated to gene discovery with the goal of developing molecular diagnostic products and services that provide clinicians with new tools to personalize diagnosis, treatment, and therapy. IntegraGen, and its wholly owned U.S. subsidiary IntegraGen, Inc., are focused on the prevention and proactive management of complex debilitating diseases, and dedicated to addressing the needs of patients, clinicians, and advocacy groups. IntegraGen’s Genetic Services Business, based in Evry, France, also provides state of the art Genotyping Services to the research community. With discovery and intellectual property focused on Autism, Oncology, IntegraGen’s Core Strategy is to deliver a portfolio of high-value molecular diagnostic products and services that drive personalized healthcare solutions for complex diseases... [PDF] IntegraGen's Press Release -

Vaxon Biotech successfully completes its Phase I/II trial of Vx-001 cancer vaccine,Phase III ready to start in NSCLC

Paris, May 19, 2010—Vaxon Biotech, a specialist in tumor immunotherapy, announces the successful conclusion of the Phase I/II trial of its Vx-001 therapeutic cancer vaccine. As a result, Vaxon is pursuing the clinical development of Vx-001 by launching a pivotal phase III trial in non-small cell lung cancer (NSCLC) in 2010, and in hepatocellular carcinoma and breast cancer in 2012-2013.

The phase I/II trial was conducted among 116 patients with different types of cancer including 33 patients with NSCLC. The primary objective was to evaluate safety of Vx-001, with a secondary objective to evaluate immune response and clinical response. Results showed that Vx-001 is safe (only grade I vaccine related toxicity was observed) and well tolerated by the patients, that it induces a long lasting vaccine specific immune response in 70 percent of patients, and that it has a significant clinical activity: four patients experienced objective response and 33 patients stabilized their disease for more than six months. Survival of vaccinated patients was related to the immune response; patients who developed immune response had a longer survival than patients who failed to do so. Analysis focused on the thirty-three NSCLC showed that Vx-001 induces long lasting disease control, including objective responses, in more than 42% of patients. Survival of NSCLC vaccinated with Vx-001 was close to 19 months, at least 50 per cent longer than normal in this patient population...

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...About Vaxon Biotech

Vaxon Biotech is specialized in tumor immunotherapy, a therapeutic approach that consists in stimulating the immune system to target and destroy tumor cells, thus preventing the tumor from progressing. Vaxon Biotech’s innovative and unique vaccine technology (“Optimised Cryptic Peptides”) significantly improves immune response and hence makes vaccines more effective. Vaccines using this technology target cryptic peptides/antigens present on the tumor cell surface. Cryptic peptides do not induce tolerance of the immune system, unlike dominant peptides, which are tolerated by the immune system and therefore generate a weak immune response.
Vaxon Biotech’s most advanced product, Vx-001, is slated to enter a pivotal Phase III clinical trial in non-small cell lung cancer (NSCLC) in 2010 with the aim of a marketing authorization in 2014-2015... [PDF] Vaxon Biotech's Press Release -

Arterial Remodeling Technologies : data from in vivo study that its stent’s biodegradability is quantifiable while preserving its mechanical...

PARIS, May 20, 2010 — Arterial Remodeling Technologies (“ART”) disclosed the results of an in vivo study of 48 porcine arteries implanted with its biodegradable stent. The study demonstrated that (1) the ART stent’s biodegradation is measurable and begins at the first day of implant; (2) that the ART stent retains high radial strength, thus maintaining its structural integrity during biodegradation; and, (3) that the ART stent causes virtually no inflammation of the blood vessel wall.
Previous validating data regarding ART’s next-generation bioresorbable stent approach has been published in the January 2010 special supplement of EuroIntervention, a peerreviewed journal. The paper was authored by Antoine Lafont, M.D., Ph.D., Head, Interventional Cardiology Department, Georges Pompidou Hospital (Paris); Past Chairman, Interventional Cardiology Group, European Society of Cardiology (ESC)...

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...About Arterial Remodeling Technologies (“ART”)
Arterial Remodeling Technologies (“ART”) is developing bioresorbable coronary
polymer stents that promote the natural remodeling of an injured artery after angioplasty.
The Company’s technology is based on intellectual property originating from three
esteemed institutions: the Cleveland Clinic; the French national research institute,
CNRS (Centre National de Recherche Scientifique), Montpellier, France; and, Descartes
University, Paris... [PDF] Arterial Remodeling Technologies' Press Release -