News
Company News: Curetis Presents First Data on Novel Unyvero™ i60 ITI Application for Implant and Tissue Infections
– New cartridge detects 114 targets
– Roll-out in collaboration with Heraeus Medical expected in early 2014
Curetis AG today announced first details on its new Unyvero™ i60 ITI application for the diagnosis of implant and tissue infections. The cartridge has been developed in close collaboration with Heraeus Medical GmbH, a company focused on orthopedic biomaterials. The data were presented at this year´s 65th Joint Annual Meeting of the German Society for Hygiene and Microbiology and the German Society for Infectious Diseases (DGHM/DGI 2013) in Rostock, Germany.
The new Unyvero™ System cartridge covers a broad range of infections common after abdominal as well as bone and joint surgery, trauma (e.g. burns) or skin and soft tissue infections, including diabetic foot disease. In combination with the unique Unyvero™ L4 Lysator it is also possible to process biofilm samples, an important prerequisite for the fast and reliable diagnosis of implant infections (catheters, joints etc.).
The multiplex panel of the novel i60 application covers a total of 114 targets – 91 pathogens (gram-negative & gram-positive bacteria and fungi) and 23 resistance markers – relevant for eight clinical indications. At the conference, Curetis presented data from first evaluation studies demonstrating that the panel is able to detect pathogens in orthopedic and surgically relevant fresh and frozen samples, such as synovial and sonication fluids, swabs, and tissue material. All results were confirmed by standard microbiology culture. Of note, the i60 application also detected additional pathogens not covered by standard methods, e.g. anaerobic bacteria known to be involved in biofilm-formation on orthopedic implants.
Following the successful completion of assay development, Curetis is now running validation and verification tests. The company aims to run a clinical CE performance evaluation study this fall with a goal of obtaining CE-IVD marking for the Unyvero™ i60 ITI cartridge by the end of 2013.
Company News: vasopharm Reports Endorsement of Phase III Trial Design in Traumatic Brain Injury by European Medicines Agency
– Company receives protocol assistance from the EMA
– Agreement on endpoint, dosing scheme, trial size and use of Phase II dataset
vasopharm GmbH, a privately held biopharmaceutical company focusing on novel therapeutics for the treatment of cerebro- and cardiovascular diseases, today announced the positive outcome of a scientific advice meeting with the European Medicines Agency (EMA). The EMA’s Committee for Medicinal Products for Human Use (CHMP) has agreed to all major items of vasopharm’s proposed protocol for the realisation of a European Phase III study of VAS203 in patients suffering from traumatic brain injury (TBI).
In essence, the CHMP agreed on the primary endpoint, the proposed dosing scheme and the trial size. For the final evaluation, the CHMP further agreed to include the available Phase II dataset as supportive information for a potential approval of VA203 in the treatment of TBI patients. VAS203, the company’s lead compound, is an allosteric nitric oxide synthase inhibitor and in development for the treatment of TBI patients. The compound met all clinical endpoints for safety and demonstrated strong evidence of clinical benefit in the explorative Phase IIa NOSTRA trial in TBI patients. The trial was completed in 2012.
The company is also seeking advice from the U.S. Food and Drug Administration (FDA) in order to include U.S.-based clinic trial centres in a single Phase III trial in patients with TBI.
Company News: Immunology Data Further Underline the Positive Outcome of a Phase IIb Trial of Anergis´ Birch Pollen Allergy Vaccine AllerT
– Treatment with AllerT increases allergen-specific IgG4 antibody levels by a factor of 20
– AllerT administration produces humoral immune responses similar to conventional desensitization
Anergis, a company focusing on proprietary allergy vaccines, today reported immunology data from the Phase IIb study of its lead compound AllerT. In the trial, AllerT induced a strong increase of allergen-specific IgG4, a key marker of immunological responses typically observed in successful, conventional allergy immunotherapy (AIT, previously known as allergen-specific immunotherapy, or SIT). In September 2013, Anergis had reported that the trial showed significant clinical effects of AllerT on multiple efficacy endpoints, including combined symptom and medication scores assessed daily throughout the natural birch pollen season 2013.
In the placebo-controlled, double-blind, multicenter trial, a total of 240 patients from 24 European trial centers were randomized to receive 5 pre-seasonal injections of AllerT 50 μg, AllerT 100 μg, or placebo over a period of 2 months between November 2012 and March 2013.
Allergen-specific IgG4 antibody blood levels were similar in all three groups before treatment. Four weeks after completion of treatment and prior to the birch pollen season, the IgG4 levels were markedly and similarly increased in both AllerT dose groups by a factor of about 20 compared to baseline and to placebo (all tests p < 0.0001). During the subsequent birch pollen season, the IgG4 levels remained similarly elevated in both dose groups, showing that a plateau of IgG4 had been reached. By contrast, IgG4 levels remained unchanged in the placebo group during treatment and during the pollen season.
Anergis’ COP (Contiguous Overlapping Peptide) technology can be applied to a broad spectrum of allergy indications. At present, Anergis is developing AllerT for the treatment of birch pollen allergy, AllerR for ragweed pollen allergies and AllerDM for dust mite allergies.
Company News: ISA Pharmaceuticals Establishes Advisory Board
– Renowned Specialists to Support Development of ISA’s Advancing Pipeline –
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced the establishment of an advisory board of seasoned executives and scientists. Five world-renowned specialists will bring strong clinical, regulatory, scientific and business expertise to assist ISA in developing and implementing its corporate and R&D strategy.
The members of ISA’s advisory board are:
Alex Eggermont, M.D., Ph.D., is General Director of the Institut de Cancérologie Gustave Roussy (IGR, Villejuif) and a Professor of Surgical Oncology at Rotterdam’s Erasmus University (Netherlands). Prof. Eggermont specializes in preclinical and clinical / translational oncology, and is a specialist in immunotherapy research and the treatment of melanomas and sarcomas.
Ulrich Granzer, Ph.D., is a pharmacist and founder of Granzer Regulatory Consulting & Services. In addition, he is a founding member and President of the Board of the German Association of Regulatory Affairs (DGRA). He has long-standing experience in all regulatory aspects of the pharmaceutical industry from his time at Glaxo (now GSK), BASF, Pharma / Knoll, and Bayer. At Bayer, as Vice President of Global Regulatory Affairs he was responsible for all regulatory aspects of the development and submission of projects worldwide. Dr. Granzer’s expertise in regulatory affairs extends to both U.S. (FDA) and European (EMA) regulatory authorities.
Drew M. Pardoll, M.D., Ph.D., is a cancer immunologist and an Abeloff Professor of Oncology, Medicine, Pathology and Molecular Biology and Genetics at the Johns Hopkins University School of Medicine. He is also Director of Cancer Immunology at the Sidney Kimmel Comprehensive Cancer Center. Dr. Pardoll specializes in cancer immunology and cancer immunotherapy and has contributed to the development of many immunotherapies.
Sjoerd H. van der Burg, Ph.D., is a Professor in Experimental Cancer Immunology and Therapy at the Department of Clinical Oncology of the Leiden University Medical Center. He has extensive experience in tumor immunology and the immunotherapy of cancer, in particular the development of therapeutic vaccine strategies and the adoptive transfer of ex-vivo expanded T cells. He is specialized in the immunomonitoring of human T cell responses and is the current Chair of the Association for Cancer Immunotherapy Immunoguiding Program (CIP).
Mark Krul, Ph.D., is a co-founder of ISA Pharmaceuticals and a co-founder and Managing Partner at Aglaia BioMedical Ventures, a Dutch venture firm focusing on oncology. He is a molecular biologist and immunologist with over 20 years of experience in anti-cancer drug development, among others as a Research Manager at the European Cancer Center and as Head of the Department of Molecular Virology at the National Institute of Public Health and Environmental Protection in the Netherlands. Mark Krul has a strong track record in founding, managing and financing early-stage oncology companies. Mark Krul will chair ISA’s advisory board.