Archive: Company News
Company News: New Favorable Clinical Evaluation Data for Unyvero™ P50 Pneumonia Application
– Dutch study demonstrates excellent sensitivity of Unyvero™ cartridges –
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced positive clinical data from an independent study conducted by researchers from the Department of Medical Microbiology of Maastricht University Medical Center (MUMC), Maastricht, the Netherlands. The data demonstrate the high clinical sensitivity of the Unyvero™ P50 Pneumonia application in detecting pathogens, including samples with low pathogen concentrations.
The researchers compared the performance of the Unyvero™ P50 cartridge with conventional microbiology culture in broncho-alveolar lavage fluid (BALF) samples for the diagnosis of ventilator-associated pneumonia (VAP), a common complication in intensive care patients. The most frequent causes are Pseudomonas aeruginosa, Staphylococcus aureus and Enterobacteriaceae.
Using the quantitative culture standard, Unyvero™ P50 Pneumonia correctly detected 8 different important pathogens in all VAP samples (n=44) at 100% sensitivity. The overall sensitivity of the Unyvero™ P50 panel was 88.6% at clinically relevant pathogen concentration. Unyvero™ P50 was also able to detect 8 different clinically relevant pathogens in 12 patient samples where conventional microbiology culture failed. This data confirms previous results where Unyvero™ had consistently detected pathogens missed by conventional culture.
The data were presented at the Scientific Spring Meeting of the Koninklijke Nederlandse Vereniging voor Microbiologie (Royal Dutch Society for Microbiology) KNVM and Nederlandse Vereniging voor Medische Milieukunde (Dutch Association for Environmental Medicine) NVMM 2014 in Arnhem, The Netherlands.
Company News: Anergis Completes Enrolment in the Long-Term Efficacy Trial of Lead Compound AllerT
– Results expected for Q3, 2014 –
Anergis, a company discovering and developing proprietary allergy vaccines, today announced that it has completed the enrolment of 196 subjects in the long-term efficacy trial of its birch pollen allergy vaccine AllerT, and expects to release results in the third quarter of 2014.
The long-term efficacy trial of AllerT is a double-blind, placebo-controlled, field-based clinical trial assessing the persistence of the efficacy of AllerT in post-treatment years.
All 196 patients participated in the field-based Phase IIb trial with AllerT in 2013. They all received a two-month double-blind, randomized treatment with AllerT or a placebo prior to the 2013 birch pollen season, and were then followed for efficacy during the 2013 birch pollen season, i.e. in conditions of natural pollen exposure. Last year’s Phase IIb trial had shown the efficacy of AllerT on allergy symptoms during the first post-treatment birch pollen season, based on combined symptom and medication scores, quality of life and other endpoints.
In the new long-term efficacy trial, the enrolled patients agreed to collect their daily allergy symptoms and allergy medication using electronic diaries, exactly as was done during the previous trial/season. The patients have not received any further investigational treatment since their pre-seasonal two-month treatment in early 2013.
The trial will thus provide efficacy data for AllerT during the second season post-treatment without any intervention since the initial two-month, pre-seasonal treatment. Anergis had already shown that patients from the AllerT Phase IIa trial had a persistent elevation in allergen-specific antibodies (IgG4) until at least the fourth post-treatment season.
Company News: New Clinical Data Demonstrate Strong Synergy between Cancer Vaccine ISA101 and Chemotherapy
– Data presented at the AACR Annual Meeting 2014
– Potential new treatment being developed for patients with late-stage cervical cancer
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, has announced new clinical data on its lead product candidate ISA101. ISA101 is a therapeutic cancer vaccine for the treatment of high-risk, HPV16-induced diseases, such as cervical cancer. The data were presented by principal investigator Prof. Sjoerd van der Burg, Ph.D., at this year’s American Association for Cancer Research (AACR) Annual Meeting in San Diego.
The data demonstrate strong synergy between ISA101 and chemotherapy, offering potential new treatment options for cervical cancer patients scheduled to receive standard chemotherapy with carboplatin / paclitaxel.
Prof. van der Burg and his group evaluated the immunological and clinical responses of patients with advanced cervical carcinoma in a Phase I combination trial. In this pilot trial, patients received ISA101 in combination with standard chemotherapy cycles (carboplatin / paclitaxel). Almost all patients showed a strong immune response to the ISA101 vaccine. Comprehensive immune monitoring confirmed the beneficial effect of myeloid suppressor cell depletion associated with a robust induction of HPV16-specific T-cell responses that were sustained throughout several cycles of chemotherapy.
The observation that depletion of myeloid suppressor cells by a carboplatin/paclitaxel chemotherapy regimen enhances the immune response to ISA101 is in line with prior observations that tumors promote immune tolerance starting early in the disease and that chemotherapy can restore immune competence in cancer patients.
Based on these results ISA has initiated a phase I/II study (CervISA) in October last year testing ISA101 in combination with carboplatin, paclitaxel and pegylated interferon alpha in women with advanced or recurrent cervical cancer.
The presentation titled “Synergistic effects of properly timed HPV16 SLP vaccination during standard carboplatin-paclitaxel chemotherapy in animals and patients with metastatic cervical carcinoma“ was given at the Minisymposium MS.IM02.01 “Immune-based Therapies: Responses, Biomarkers, and Mechanisms” on Monday, April 07, 2014, at 3:20 PM in Room 6CF at the San Diego Convention Center.
The abstract # 2938 is available at the AACR website www.aacr.org.
Company News: InDex Pharmaceuticals and Almirall enter into a license agreement for European rights of the phase III drug candidate Kappaproct®
InDex Pharmaceuticals and Almirall announced today that they have signed a license agreement for the European marketing rights to the drug candidate Kappaproct®. Under the terms of the agreement, InDex is eligible for an upfront payment as well as success driven milestone payments with a total deal value that could exceed EUR100M. InDex is also entitled to receive double digit royalties from Almirall on the European net sales of Kappaproct®.
InDex Pharmaceutical’s lead drug candidate Kappaproct® is a DNA-based immunomodulatory sequence (DIMS) that targets the toll-like receptor 9 (TLR9). Kappaproct is a potential treatment for severe Ulcerative Colitis (UC), a debilitating, chronic inflammation of the large intestine. The results from the ongoing Phase III trial COLLECT are expected in mid-2014.