Tag: Clinical Data
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: New Clinical Data on Cancer Vaccine ISA101 to Be Presented at the AACR Annual Meeting 2014
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced that principal investigator Prof. Sjoerd van der Burg, Ph.D., will present new clinical data on ISA101 at this year’s American Association for Cancer Research (AACR) Annual Meeting. ISA101 is a therapeutic cancer vaccine for the treatment of high-risk, HPV16-induced diseases.
The presentation titled “Synergistic effects of properly timed HPV16 SLP vaccination during standard carboplatin-paclitaxel chemotherapy in animals and patients with metastatic cervical carcinoma“ will be 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: Curetis to Present Clinical Unyvero™ Data at Major Scientific Conferences
– Lower Respiratory Tract application: initial clinical evaluation data from U.S. center will be presented at ICAAC 2013 (USA)
– New application Implant and Tissue Infections: first data will be presented at DGHM/DGI meeting (Germany)
Curetis AG today announced the upcoming presentation of new clinical data on two Unyvero™ applications at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2013) in Denver, CO (Sept. 10-13) and 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 (Sept. 22-25).
Curetis will introduce clinical data from a U.S. pre-FDA trial phase of its Unyvero™ LRT (Lower Respiratory Tract) infection application at the ICAAC conference. The poster ‘Evaluation of a Molecular Multiplex Test For Detection of Respiratory Microorganism and Antibiotic Resistance Genes in Clinical Specimens’[1] will present data generated at Northwestern Memorial Hospital (Chicago, IL) during the initial familiarization and training phase for the FDA trial. The FDA trial is now being conducted at four sites; all clinical data are blinded until completion of this ongoing trial which is expected for 2014. The LRT application is already marketed and branded outside the U.S. as the Unyvero™ P50 pneumonia application. During ICAAC, Curetis will also showcase its Unyvero™ Solution at booth no. 822 in the exhibition hall.
Moreover, Curetis will present data of its novel Unyvero™ i60 ITI application for the diagnosis of implant and tissue infections detecting pathogens and resistance markers at the annual DGHM/DGI meeting. The poster presentation ‘A new Multiplex PCR-Panel for the Detection of Pathogens Related to Implant and Tissue Infection’[2] will introduce the panel chosen for the diagnosis of eight indication areas and present initial validation and verification data with clinical samples. Curetis will also host the industry symposium ‘Implant and Tissue Infections – A Diagnostic Challenge’ (Sept. 24, 12:15-1:15pm, Auditorium 2) featuring talks and case studies by Prof. Petra Gastmeier (Berlin, Germany), Dr. Anne Thews (Holzgerlingen, Germany), Prof. Andrej Trampuz (Berlin, Germany), and Dr. Olivier Borens (Lausanne, Switzerland). A second poster based on data independently generated at the University Hospital in Basel, Switzerland will present a ‘Comparison of the Unyvero™ Pneumonia P50 Assay with standard culture and antimicrobial susceptibility testing’.[3]
[1] Presentation D-1655a, Session: #214 – Diagnosis and Epidemiology of Respiratory Infections, Sept. 13, 8:30-10:30am, Exhibit Hall A.
[2] Presentation DVP02, Postersession I (StAG Diagnostic Microbiology and Microbiology Procedures Quality Standards), Sept. 23, 3:00pm, Auditorium 1
[3] Presentation KMP14, Postersession II (StAG Clinical Microbiology and Infectious Diseases), Sept. 24, 3:00pm, Room HS323.