Tag: Clinical Data
Company News: Aleva Neurotherapeutics Announces Promising Clinical Data on Directional Deep Brain Stimulation with directSTIM™
– Data Presented at the 2013 Quadrennial Meeting of the World Society for Stereotactic and Functional Neurosurgery (WSSFN) –
Tokyo, Japan, May 30, 2013 – Aleva Neurotherapeutics, a company developing next-generation implants for Deep Brain Stimulation (DBS) in major neurological indications such as Parkinson´s disease or depression, today announced interim clinical data of an interventional, intraoperative pilot study of its novel directSTIM™ electrode. Data were presented at the 2013 Quadrennial Meeting of the World Society for Stereotactic and Functional Neurosurgery (WSSFN) in Tokyo, Japan, on May 30.
In the ongoing pilot study, clinical investigators assessed the intraoperative clinical effect of directional stimulation using the directSTIM™ lead. It features two rings consisting of three independent electrodes each. The angular position of the electrodes allows stimulation at 0°, 120° and 240° directions. After assessment, directSTIM™ was removed and replaced by a classical, ring-shaped permanent DBS lead.
The data reported in Tokyo are based on 5 males with Parkinson Disease, which underwent Subthalamic Nucleus (STN) DBS, and 2 males with essential tremor, which underwent Ventral Intermediate Nucleus of the Thalamus (Vim) DBS. Directional stimulation was tested at the target determined for the permanent lead. The clinical investigators compared the therapeutic window (TW, defined as the electrical current threshold at which side effects occur minus the current threshold at which a significant therapeutic effect is observed) of directional and classical stimulation. Directional stimulation resulted in an improved therapeutic window in five of six patients (the ratio could not be measured in one of seven patients). No adverse event took place.
“This is a real breakthrough in the field of DBS. At present, DBS is carried out using ring-shaped electrodes,” said Claudio Pollo, MD, Head of Functional Neurosurgery at the University Hospital, Bern, Switzerland and Principal Investigator of the study. “This intraoperative study is the first to investigate the proof-of-concept of directional stimulation in humans. The increased therapeutic window demonstrated in the study suggests that directional stimulation is more selective for beneficial effects while avoiding side effects. Moreover, the observed side effects were consistent with what we expected given the anatomical structures surrounding the stimulated area.”
“We are very pleased with the data, as we have proof-of-concept in an intraoperative setting that directional stimulation is measurable and that it is different from classical stimulation,“ said Jean-Pierre Rosat, CEO of Aleva Neurotherapeutics. “This is very promising as it indicates that the effectiveness of DBS may be improved by our novel electrodes.”
Alain Dransart, Aleva’s Clinical and Regulatory Director, concluded: “We are delighted by the way the study is conducted and by the excellent collaboration with the investigators. The pilot study will be completed by the end of this year and we believe its results will pave the way for a future directSTIMTM chronic study.”
Company News: Curetis to Present Clinical Unyvero™ Data at ECCMID 2013 in Berlin
– Company to host medical symposium on molecular antibiotic resistance testing in standard care
Curetis AG today announced the presentation of top-line clinical data from various European cohorts and performance evaluation studies of the Unyvero™ System and the Unyvero™ P50 pneumonia cartridge at the European Conference of Clinical Microbiology and Infectious Diseases (ECCMID) 2013 in Berlin. Data from the analysis of more than 1,000 patient samples and case reports will be presented in the poster session “Molecular diagnosis of bacterial pneumonia” on Monday, April 29, from 12:30-1:30pm.*
As an ECCMID silver sponsor, Curetis will also host a medical symposium on Saturday, April 27 (1:30-3:30pm) in Hall B (P.32). The symposium entitled “Does molecular antibiotic resistance testing improve diagnostics and standard of care?” will be chaired by Professors Carl-Erik Nord and Christian G. Giske (both Stockholm/Sweden). Featured presentations will be “Genotypes and phenotypes of emerging resistance” (Prof. David Livermore, Norwich/UK) and “Correlation between genotypes and phenotypes: clinical implications” (Prof. Gian Maria Rossolini, Siena/Italy). The session will conclude with the discussion of case studies in pneumonia (Prof. Antonio Torres, Barcelona/Spain, Prof. Eiman Mokaddas, Kuwait) and implant & tissue infection (Prof. Andrej Trampuz, Berlin/Germany and Prof. Olivier Borens, Lausanne/Switzerland).
Curetis will be exhibiting its CE-marked Unyvero™ System at booth no. 323 in hall 15. Several international distribution partners of Curetis will also attend ECCMID.
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*Abstract Nr. 2360: M. Klein et al., First clinical validation of a rapid molecular test (Unyvero™ P50 Pneumonia Application) detecting microorganisms and antibiotic resistances in patients suspected with severe pneumonia.
Company News: Micromet Presents Promising New Data on Anti-Cancer BiTE® Antibody Blinatumomab
Micromet has presented promising new data from two clinical trials with its lead BiTE® antibody, blinatumomab, at the 53rd American Society of Hematology (ASH) Annual Meeting in San Diego, CA. Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells. The compound is being developed for the treatment of leukemia and B cell lymhoma.
The data show that Micromet’s blinatumomab more than doubled the complete remission rate produced by current standard therapies used to treat adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).
In a phase 2 single-arm dose-ranging trial, 68% of evaluable patients (17/25) across all tested doses and schedules achieved a complete response (CR) or complete response with partial hematologic recovery (CRh*) following treatment with blinatumomab. Of the 12 evaluable patients who received the selected dose and schedule 75% (9 of 12) achieved a CR or CRh*. Notably, all responders also achieved a molecular response, or in other words, had no evidence of remaining leukemic cells detectable in the blood or bone marrow.
A first interim analysis of the time impact of blinatumomab treatment was conducted for the initial 18 patients enrolled to the trial. The median survival had not been reached, with a median follow-up period of 9.7 months. With combination chemotherapy, median survival typically ranges from 3 – 6 months1-5. 12 of the initial 18 patients had a CR or CRh* with a median duration of response of 7.1 months. Based on the results of this study, the Company initiated a global phase 2 study in this patient population in November 2011.
Moreover, new findings from a phase 1 trial presented at the meeting demonstrate Micromet’s blinatumomab induces durable responses in patients with extensively pre-treated diffuse large B cell lymphoma (DLBCL).
Data focused on a cohort of 13 patients with DLBCL, of which 11 received the target dose and were evaluable for response. Of these 11 patients, 6 (55%) achieved an objective response following treatment with blinatumomab. 4 of 11 patients (38%) achieved a complete response. Patients were treated with a single course of blinatumomab induction therapy for up to eight weeks. As of October 2011, 5 of 6 patients had ongoing responses for up to 16.6 months. The median duration of response had not been reached with a median observation time of 7.1 months.
All patients enrolled in this study had received prior rituximab-containing regimens. Most had received three or more prior lines of therapy, including 8 of 13 patients with prior autologous stem cell transplant.