News
Company News: Curetis AG Initiates Clinical Trial in the U.S. Towards FDA Clearance
– Prospective Multi-Center Trial to Enroll Over 2,000 Clinical Samples –
Curetis AG today announced the start of a clinical trial of its Unyvero™ System and the corresponding LRT (lower respiratory tract) application in the U.S. The company expects enrollment completion within the next 12-15 months, followed by a 510(k) submission to the FDA in 2014.
The prospective, multicenter trial will include samples collected from more than 2,000 hospitalized patients suspected to have a lower respiratory tract infection and several hundred retrospective samples with known microbiology culture results for rare pathogens. Samples will be processed by the Unyvero™ Lysator, transferred to the LRT cartridge, and tested by the Unyvero™ Analyzer.
Primary endpoint of the study will be assay performance defined as clinical sensitivity and specificity compared to microbiology culture (today’s diagnostics standard of care) and to a composite reference diagnosis that incorporates PCR and sequencing to determine clinical truth whenever microbiology culture results are negative.
Trial sites include Northwestern University (Chicago, IL) and North Shore-LIJ Health System (Lake Success, NY), among others. The Principal Investigator is Prof. Christine C. Ginocchio, Senior Medical Director and Chief, Division of Infectious Disease Diagnostics, North Shore-LIJ Health System. Curetis has contracted Aptiv Solutions as its CRO and Neil Mucci of GlobalBioclinical as project manager in the US.
The LRT application analyzes 39 DNA targets simultaneously from a single patient sample. Results are available within about 4 hours. The pathogen panel has been selected for clinical relevance based on current international clinical guidelines and has been reviewed by clinical experts in Europe and the USA. Resistance genes were chosen by frequency and clinical significance. A similar product, the Unyvero™ P50 pneumonia cartridge is CE-marked and currently marketed in Europe and the Middle East.
Company News: Curetis and Scholz Collaborate to Industrialize and Scale-Up Production of Unyvero(TM) Cartridge Plastics Parts
– German family firm ‘Scholz-HTIK – High Tech in Kunststoff’ has been selected by Curetis based on systematic benchmarking process –
Curetis AG today announced a strategic supply chain partnership with German family business Horst Scholz GmbH + Co. KG for the production of high-quality plastics parts for its Unyvero™ Cartridge.
Under the agreement, Curetis will invest more than € 2 million in multi-cavity tools for all Unyvero™ Cartridge plastics parts. Curetis has already ordered several multi-cavity tools from Scholz. The first tools will be delivered in early 2013.
Scholz has been chosen by Curetis due to its unrivalled experience and expertise in medical device-grade injection molding, its state-of-the-art facilities and equipment as well as its cleanroom manufacturing infrastructure.
Scholz has a long track record and outstanding commitment to total quality management, e.g. regarding the use of CT scanners for quality control of parts. Curetis expects a smooth transition from its previous R&D phase supplier to the serial production and scale-up run by its new partner Scholz.
Company News: akampion’s Clients Featured in Major Trade and Economics Media
akampion has successfully positioned its clients in various international trade and economics media during the last weeks.
Among others, Surgical Process Institute, a provider of all-in-one solutions for surgery-focused clinics, has been introduced in a four-page article in Wirtschaftswoche 47 (Nov. 19, 2012). Wirtschaftswoche is the world’s largest German-language economics magazine with a circulation of >173,000 copies, reaching 0.9 million readers.
bubbles & beyond, which is developing intelligent fluids for a variety of industrial and other applications, has been introduced in a two-page article in brand eins (12/2012), Germany’s most prestigiuos monthly economics magazine (circulation of nearly 110,000 copies).
European Hospital (Vol. 21, Issue 5/12) in November reported on the collaboration of molecular diagnostics company Curetis AG with Heraeus Medical to develop a novel Unyvero(TM) cartridge to detect pathogens and antibiotic resistances in implant and tissue infections (ITT). The same issue is introducing French company Nanobiotix SA which is developing a revolutionary new approach for cancer radiotherapy. The company went public in France earlier this month. European Hospital has a circulation of 30,000 copies and is read widely across Europe (majority of copies sold in Germany, UK, France, Russia, Spain, Italy) – mostly by hospital managers and chief physicians.
L’Agefi, Switzerland’s leading business and financial newspaper (readership: 115,000), on November 7 reported on the start of a European Phase IIb trial of the company’s birch pollen allergy vaccine. The news was also picked up by BioWorld and BioCentury.
Company News: Long-Term Immunomodulation Induced by Anergis´ COP Allergy Vaccine AllerT Now Extends to the 4th Year After Treatment
Patients with birch pollen allergy who received an ultra-fast allergy vaccine four years ago maintain an elevated level of antibodies against the allergen, reports Swiss biopharmaceutical company Anergis.
The company, which is developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, today announced new data on the immune-regulatory effect of its AllerT vaccine.
In 2008/2009, twenty patients suffering from moderate to severe allergies to birch pollen were enrolled in a double-blind, randomized, placebo-controlled Phase I/IIa trial and received 5 subcutaneous injections over 2 months of either AllerT (N=15) or placebo (N=5). Four years later, all subjects were invited to return to the trial center. In subjects who had received AllerT, blood levels of so-called IgG4 antibodies against specific birch pollen allergens were similar to those reported after 2 years (in 2010) and still 4.5 times higher than the pre-treatment baseline level (p< 0.001). Placebo-treated patients showed no median change from baseline in allergen-specific IgG4 at any time during the trial treatment period, nor after the 2010 and 2012 birch pollen seasons.
Earlier this week, Anergis also announced the start of a large, 300-patient real-life seasonal efficacy phase IIb trial with AllerT in patients allergic to birch pollen. This trial is being conducted in multiple European countries [NCT01720251].