News
Food for Thought: Weekly Wrap-Up
Ulrike von Leszczynski in Die Welt introduces a novel submersible which can dive up to 6 kilometers deep but weighs only 500 kg. The 3,5 meter long “autonomous underwater vehicle” named DNS Pegel does not need a pressure chamber as it is being flooded when diving. Instruments and electronics have been developed to withstand the conditions and most are protected by silicone.
In Der Spiegel, Steve Ayan, editor-in-chief of Gehirn & Geist, interviews Florian Holsboer, director of the Max Planck Institute of Psychiatry who explains how and why psychiatry will be revolutionized by tailor-made, personalized medicine to treat conditions such as anxiety, depression and others. Holsboer explains that psychiatric diseases are caused by a complex interplay between genes and environment in which the environment also influences the pattern of genes involved in a certain condition at a certain point in time. In the future, he predicts, “we will be able to generate biochemical snapshots using genetic tests and biomarkers.”
Marc-Denis Weitze in Neue Zürcher Zeitung (NZZ) introduces efforts by scientists from the Max Planck Institute for Biochemistry in Martinsried, the Natural and Medical Sciences Institute (NMI) at the University of Tuebingen and the Department of Biosystems Science and Engineering of ETH Zurich in Basle to record the activity of neurons in neuronal networks – a challenging task as chips and electronics elements need to withstand salty solutions for months. The latest innovation is a chip providing 32,000 contact points on a 2.6 square millimeter area. Nicola von Lutterotti, also in NZZ, reports on US and Swiss studies looking into the causes of hospitalizations. In Switzerland, up to 7% were due to overdosing of medications (either by doctors or accidentally by patients) or prescriptions of medications without observing warnings on potential interactions given on the label.
In the New York Times (NYT), Nicholas Wade reports on the successful genetic therapy of six patients with hemophilia B. The disease was corrected by transferring a working version of the factor IX gene via the adeno-associated virus-8 (AAV-8). The article points out that the therapy did not work or ceased to work in some of the patients. In other patients, the factor IX is produced in sufficient quantities for up to 22 months so that they can live without medications.
The New Scientist this week features a study by researchers from the University of Freiburg, Germany, in which symptoms of multiple sclerosis (MS) have been reverted in mice by injecting RNA oligonucleotides that stimulate the expression of interferon-B (IFNb). IFNb is known to be efficacious in humans with MS. However, 80% of people treated with IFNb injections develop antibodies against IFNb. If produced by the body itself the problem might be avoided.
And finally, “self-hacking” can be dangerous to your health, reports Klaus Vogt in Die Welt. Self hackers are promoting the “Quantified Self” movement and are recording, rating and sharing a wealth of body functions – from weight and blood pressure to feelings and data on sex and meditation – on a daily or even more frequent basis. While the movement already finds interest among medtech companies and data providers, medical professionals now warn that the underlying condition can become addictive. The akampioneer recommends software developers should program a meta app analyzing the quantified self data so that an addiction value can be posted on top.
Keeping an Eye on … Nanobiotix
French nanomedicine company Nanobiotix is featured in a one-page article by Susanne Kutter in this week’s Wirtschaftswoche. The article (not yet online) features the technology by Nanobiotix and its NBTXR3 compound which has been developed to enhance the local destruction of tumor mass during radiotherapy.
NBTXR3 is a nanoparticle consisting of hafnium oxide crystals. Once injected into the tumor, NBTXR3 accumulates in the cancer cells. Due to the physical properties of hafnium oxide, the particles emit huge amounts of electrons upon radiation. This leads to the formation of radicals within the tumor cell, which in turn damage the cancer cells and cause their targeted destruction. NBTXR3 particles are inert and emit electrons only during their exposure to radiotherapy. As a result, the destructive power of standard radiation therapy could be locally and selectively enhanced within the tumor cells.
In September, the company started a clinical trial of the compound which is regulated in the EU as a medical device.
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.
Company News: MediGene Presents Overall Survival Data from a Phase II Trial of EndoTAG®-1 in Triple-Negative Breast Cancer (TNBC)
– Positive efficacy trend of EndoTAG®-1/Paclitaxel combination therapy confirmed
– Subgroup analysis reveals encouraging overall survival data with EndoTAG®-1 plus paclitaxel combination therapy
MediGene AG today announced median overall survival data from its phase II trial of EndoTAG®-1 for the treatment of triple-negative breast cancer (TNBC), which was presented at the San Antonio Breast Cancer Symposium in San Antonio, USA. The secondary endpoint data confirm the positive efficacy trend of EndoTAG®-1 in combination therapy with standard weekly paclitaxel, which was previously reported by the primary endpoint data (progression-free survival rate at 16 weeks). Furthermore, an additional analysis of a subgroup of patients not predefined in the study protocol (119 of 140 patients: ECOG 0/1, first-line therapy for advanced cancer) showed encouraging overall survival data with EndoTAG®-1/paclitaxel combination therapy. The data were presented by Prof. Dr. Ahmad Awada, principal investigator of this trial and Head of the Medical Oncology Clinic at Jules Bordet Institute in Brussels, Belgium.
140 patients diagnosed with TNBC participated in the phase II clinical trial. Patients were randomized to three groups and received either EndoTAG®-1 in combination with weekly paclitaxel (55 patients) or EndoTAG®-1 monotherapy (57 patients). The third group (28 patients) only received weekly paclitaxel. The patients treated with combination therapy received 22 mg/m2 EndoTAG®-1 plus 70 mg/m2 paclitaxel once per week. EndoTAG®-1 monotherapy was administered twice per week, in a dosage of 44 mg/m2 per treatment. The paclitaxel monotherapy consisted of a once weekly 90 mg/m2 dose. The clinical trial was conducted in more than 30 centers in several European countries and in India. The study was not powered for intergroup comparisons.
Median overall survival time (as at reference date “visit week 41” of the last patient treated) for those 133 patients with TNBC status confirmed by central lab was 13.0 months in the EndoTAG®-1/paclitaxel combination therapy arm (51 patients), 11.9 months in the EndoTAG®-1 monotherapy arm (57 patients), and 10.1 months in the paclitaxel monotherapy arm (25 patients). Further data analysis of this group was done for those 124 patients treated per protocol. Median overall survival in this group was 15.1 months in the EndoTAG®-1 combination therapy arm (48 patients), 12.5 months in the EndoTAG®-1 monotherapy arm (52 patients), and 8.9 months in the paclitaxel monotherapy arm (24 patients).
Additionally, MediGene analyzed a subgroup of patients that was not predefined in the study protocol. This included patients with centrally confirmed TNBC status, ECOG performance status of 0/1 at the start of the clinical trial and who received first-line treatment after tumor relapse (119 patients). Median overall survival in this group was 17.8 months in the EndoTAG®-1 combination therapy arm (45 patients), 11.7 months in the EndoTAG®-1 monotherapy arm (50 patients), and 10.1 months in the paclitaxel monotherapy arm (24 patients).
Data regarding the primary endpoint of the trial (progression-free survival rate at week 16), the secondary endpoints progression-free survival rate, clinical benefit rate, and best overall response, as well as safety and tolerability of EndoTAG®-1 have previously been published and are available at http://www.medigene.de/presse_en/endotagTNBC.