Archive: Company News
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.
Company News: Curetis Presents New Clinical Validation Data on its Unyvero™ P50 Pneumonia / LRT Application
– Clinical studies from U.S. and Switzerland confirm previous performance data
– Findings presented at DGHM/DGI 2013 and ICAAC 2013
Curetis AG today announced the presentation of additional clinical validation data on its Unyvero™ P50 / LRT application at two international conferences. The cartridge is designed to detect 16 respiratory bacteria and one fungus responsible for about 80% of severe non-viral pneumonia cases. In addition, it is able to simultaneously identify 22 antibiotic resistance markers.
At this year’s 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2013) in Denver, CO, researchers from the Northwestern Memorial Hospital (Chicago, IL) and Curetis presented data generated during the initial familiarization and training phase for the FDA trial of the Unyvero™ LRT application, an investigational device. It is based on the panel of the P50 cartridge, which is already marketed outside the U.S. In the small cohort using native clinical samples, the Unyvero™ LRT application achieved an overall sensitivity of 89% and an overall specificity of 98% for pathogen identification. Moreover, it detected 6 additional pathogens not discovered by routine microbiological culture. The resistance markers showed an overall sensitivity of 87% at an overall specificity of 97%. The authors conclude that “this data indicates that the system can significantly contribute to patient management by providing rapid pathogen identification and antimicrobial resistance profiling.”
At the 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, clinicians from the University Hospital Basel, Switzerland, presented data comparing the Unyvero™ P50 cartridge with standard microbiological culture, including anti-microbial susceptibility testing. While in 104 cases microbiology culture detected 96 pathogens evaluable by the Unyvero™ P50 cartridge, P50 detected 73 pathogens (76%). However, Unyvero™ P50 detected 68 microorganisms that were not listed in the culture report. Of these, 46% were S. pneumoniae and 10% were H. influenzae – pathogens difficult to culture or part of the oral flora for which clinical significance is not yet determined. The discrepancies are still under investigation. Phenotypic antimicrobial susceptibility or resistance was predicted correctly in 82% of cases by Unyvero™ P50. While standard culture and anti-microbial susceptibility testing took 2 to 4 days, the Unyvero™ results were obtained in less than 4.5 hours. The Basel microbiology team concluded that the “Unyvero™ Pneumonia P50 assay is able to provide fast and clinically useful results on the most prevalent pathogens causing pneumonia and their antibiotic resistance genes.”
A previous study testing more than 1,000 samples in Europe showed an overall sensitivity of 81% and an overall specificity of 96%.