Archive: Company News
Company News: InDex Pharmaceuticals announces results from COLLECT, a clinical trial of Kappaproct® in the treatment of moderate to severe Ulcerative Colitis
InDex Pharmaceuticals today reported top-line results from the double blind, placebo-controlled clinical study COLLECT. The aim of the COLLECT study was to investigate the therapeutic potential of the Toll-like receptor 9 agonist Kappaproct as an add-on therapy for patients with moderate to severe, chronic active Ulcerative Colitis.
Patients treated with Kappaproct showed statistically significant improvement on symptomatic remission (blood in stool, number of stools), registration remission (clinical remission with concurrent endoscopic remission) and the rate of colectomy. The rate of clinical remission (Rachmilewitz Index) was high in both the Kappaproct and the control group and no statistically significant difference was observed on this measure. Kappaproct was well tolerated and no safety signals compared to the standard of care treatment group were evident.
In the COLLECT study, 131 patients with moderate to severe Ulcerative Colitis with inadequate response to conventional therapy received either Kappaproct or placebo as an add-on to conventional treatment. Concominant use of TNF-α inhibitors was excluded. The study was conducted at 40 sites in seven European countries.
Kappaproct was administrated as two single rectal doses, given at week 0 and week 4. The primary endpoint was clinical remission (Rachmilewitz/CAI score of ≤4) measured at week 12. There was an unexpectedly high remission rate in the control group and there was no statistically significant difference observed on this measure. Statistically significant effects were demonstrated on the secondary endpoints symptomatic remission (blood in stool = none, number of stools weekly <35) at week 4 and 8, on registration remission (Rachmilewitz/CAI score of ≤4, plus an endoscopic Mayo score of 0 or 1) at week 4 as well as on the rate of colectomy at week 22. The patients were followed for one year from the first dose to evaluate long-term efficacy and safety. More information about the study can be found on clinicaltrials.gov.
Company News: Anergis Appoints Dr. Vanya Beltrami as Director Product Development
– Former Merck Serono Director brings strong expertise in drug development, product launches and life cycle management –
Anergis, a company discovering and developing proprietary allergy vaccines, today announced that Vanya Beltrami, PhD, has joined the company as Director Product Development.
Dr. Beltrami brings over 20 years of experience in the pharmaceutical industry with Ares-Serono, Laboratoires Serono SA and Merck Serono SA, where he held several positions with direct product development responsibility (e.g. somatropin), acting as final dosage forms project director and manufacturing product director. Most recently, he was Global Product Team Leader at the Global Product Unit Endocrinology, where he substantially expanded his cross-functional pharmaceutical development experience.
Dr. Beltrami has a long-standing track record in drug product and medical devices development as well as drug launches in multiple countries. His expertise also includes the life cycle management of a brand product generating € 250 M sales per year. Vanya Beltrami was trained as a pharmacist and holds a PhD in Formulation from the University of Geneva.
Company News: BRAIN Publication Demonstrates Significantly Improved Therapeutic Window of Deep Brain Stimulation Using directSTIM™ Directional Electrode
– Study confirms proof-of-concept for innovative DBS lead developed by Aleva Neurotherapeutics
Aleva Neurotherapeutics, a company developing next-generation implants for Deep Brain Stimulation (DBS) in major neurological indications such as Parkinson´s disease, today announced the publication of the results of an intraoperative study with its novel directSTIM™ directional lead. Data were published in the peer-reviewed journal Brain – A Journal of Neurology.*
The data presented in Brain are based on 11 patients with Parkinson´s Disease and 2 patients with essential tremor. In the study, clinical investigators assessed the intraoperative clinical effect of directional stimulation using Aleva’s directSTIM™ lead. This device features two rings consisting of three independent electrodes each. The angular position of the electrodes allows stimulation at 0°, 120° and 240° directions Directional stimulation was tested at the target determined for the permanent lead. The clinical investigators compared the therapeutic window (defined as the electrical current at which side-effects occur minus the current at which a significant therapeutic effect is observed) of directional and classical stimulation. Compared to omnidirectional stimulation, the therapeutic window in the best direction was 41% wider. Furthermore, the current threshold producing meaningful therapeutic effects in the best direction was 43% lower than in omnidirectional stimulation. No complication was observed due to the insertion and removal of the directional lead or during testing.
* Reference:
Pollo C, Kaelin-Lang A, Oertel MF, Stieglitz L, Taub E, Fuhr P, Lozano AM, Raabe A, Schüpbach M – Directional deep brain stimulation: an intraoperative double-blind pilot study. Brain 2014; doi:10.1093/brain/awu102.
Company News: Anergis to Present New COP Allergy Vaccine Data at EAACI Conference 2014 in Copenhagen
– Four scientific communications scheduled for June 8, 9 and 10, 2014 –
Anergis, a company discovering and developing proprietary allergy vaccines, today announced it will present four scientific communications on its Contiguous Overlapping Peptides (COP) allergy vaccines at this year’s European Academy of Allergy and Clinical Immunology Congress 2014 (EAACI) in Copenhagen, Denmark. The presentations focus on Anergis´ lead compound AllerT against birch pollen allergies, its house dust mite vaccine candidate AllerDM, and a general economic evaluation of allergen immunotherapy for seasonal allergies.
The following scientific communications will be presented at the EAACI Conference 2014:
Presentation Title: “AllerT™, Safety and efficacy of a birch pollen allergy vaccine based on contiguous overlapping peptides in a phase IIb study”
Presenter: Prof. Dr. Marek Jutel
Time and Date: Sunday, June 8, 2014, at 03:30pm CET
Session: Oral Abstract Session OAS12: Novel Vaccines for AIT
Abstract #: 481
Presentation Title: “Development of a hypoallergenic formulation for immunotherapy against house dust mite allergy based on Contiguous Overlapping Peptides”
Presenter: Dr. Alexander Kettner
Time and Date: Monday, June 9, 2014, at 03:45pm CET
Session: Poster Discussion Session PDS 12: AIT Mechanisms
Abstract #: 347
Presentation Title: “Effect of AllerT™ ultra-fast immunotherapy on Bet v 1 specific IgG4 and IgE levels; results from a phase IIb study”
Presenter: Prof. Dr. Christophe Reymond
Time and Date: Monday, June 9, 2014, at 03:45pm CET
Session: Poster Discussion Session PDS 12: AIT Mechanisms
Abstract #: 559
Presentation Title: “Economic evaluation of allergen immunotherapy for seasonal allergic rhinitis”
Presenter: Jean-Paul Rohmer
Time and Date: Tuesday, June 10, 2014, at 12:00pm CET
Session: Thematic Poster Session TPS64: Immunotherapy – AIT Clinics IV
Abstract #: 1411