Tag: Personalized Medicine
Company News: InDex Pharmaceuticals Develops Companion Diagnostic Test for New Ulcerative Colitis Therapy
– Personalized treatment option for patients with refractory ulcerative colitis –
InDex Pharmaceuticals today announced the development of a companion diagnostic test for Kappaproct®. Kappaproct, the lead product candidate of InDex, is currently in a phase III study as a treatment for chronic active, treatment refractory ulcerative colitis. In this study, the companion diagnostic test is being evaluated to demonstrate a correlation between test result and clinical response to Kappaproct.
In previous clinical trials, Kappaproct has shown positive effects for the treatment of steroid resistant ulcerative colitis patients. The companion diagnostic test aims to enable the pre-selection of steroid resistant patients that are most likely to benefit from Kappaproct. The proprietary in vitro test is based on a number of biomarkers and is performed on a blood sample prior to administration of Kappaproct.
A companion diagnostic is designed to assess whether a patient will respond favorably to a specific medical treatment or not. Companion diagnostics are a crucial element of personalized medicine, which is becoming increasingly important along with the demand for safer and more efficacious medicines. Companion diagnostics also reduce healthcare costs as the use of ineffective therapies can be avoided.
In 2009, InDex Pharmaceuticals launched the diagnostic test DiBiCol® in Sweden. DiBiCol differentiates between ulcerative colitis (UC) and Crohn’s disease (CD), the two major forms of inflammatory bowel disease (IBD).
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.
Food for Thought: Weekly Wrap-Up
Die Welt this week reports on plans by BayerCropScience, a division of Bayer AG, to develop new, heat- and drought-resistant wheat varieties. To accomplish this goal, BayerCropScience will refrain from introducing novel genes into the wheat genome for fear of protests in Europe. However, the company is cooperating, among others, with Israel-based Evogene to also develop genetically engineered crops for other markets.
Michael Simm in Focus features the latest accomplishments of synthetic biology in which researchers control artificially introduced networks of genes in cells and tissue. As an example, scientists from the Department of Biosystems Science and Engineering (D-BSSE) in Basle, Switzerland, have inserted genes for hormone production into cells. By adding genetic control elements that can be switched on by irradiation with blue light these genes can be controlled from outside. As an example, the researchers in vitro introduced a genetic network for the production of insulin into human tissue which subsequently was micro encapsulated and transplanted to the skin of diabetic mice. After a meal, blue light is applied to switch on insulin production in order to normalize blood sugar levels. The model works well so that the researchers are thinking about clinical trials. Already, the use of light to switch on genes has led to the new scientific discipline of optogenetics which is exploring light-controlled genes and cells to treat diseases such as Parkinson’s or epilepsy. D-BSSE researchers also developed cells carrying a network of genes that is able to normalize uric acid levels in gout patients.
Siegfried Hofmann in Handelsblatt is introducing various therapeutic approaches of biopharmaceutical companies in a series entitled “future lab 2020.” Topics range from personalized medicine to stem cell therapies to novel immune therapies.
David Shaywitz in Forbes provides a thoughtful article explaining why Silicon Valley failed to make a dent in the healthcare space: “most tech-savvy entrepreneurs lack an in-depth appreciation for the complexity of medicine in general, and the nuances of the doctor-patient dynamic they are confidently trying to influence or replace.” He goes on to say that management of high-tech companies needs to understand the science: “When a science-driven business is led by leaders who don’t even know what they don’t know, and who actually believe that the crisp powerpoint slides that bubble up for their review actually and adequately represent the science involved – then you risk making some very ignorant decisions.”
The New Scientist this week features a story on how cancer cells can be poisoned with 2-deoxyglucose. The sugar dislodges a protein protecting a suicide switch which subsequently can be triggered by ABT-263 navitoclax, a molecule under development at Genentech. The magazine also reports on a call for proposals by DARPA, the US military’s research arm, to develop small interfering RNA (siRNA) to fight bacteria. DARPA is seeking ideas for adaptable nanoparticles that can be reprogrammed “on the fly” by loading up specific siRNA to deal with outbreaks among troops.
And finally, the Economist features people pioneering the backyard generation of fuel to power their diesel cars. The recipe starts with collecting used kitchen oil, which after some filtering is broken down into esters and glycerol by adding sodium hydroxide and methanol and heating. Glycerol is drained away and the remainder is washed with water to get rid of impurities. Removing residual water and moisture is done with an aquarium bubbler. The resulting biodiesel, the article states, can be used in diesel cars without any modification. Already, British company Oilybits is selling devices to produce 120 liter batches of biodiesel in a more professional way.
Food for Thought: Weekly Wrap-Up
Joining the recent denunciation of personalized medicine in Süddeutsche Zeitung (SZ), Der Spiegel this week follows suit. Markus Grill and Veronika Hackenbroch cite Dr. Baerbel Huesing, Coordinator of Business Unit Biotechnology and Life Sciences of Fraunhofer ISI, as saying that the concept of personalized medicine is a “battle cry” of public relations: “Whoever invented it needs to be congratulated.” She added: “It is not a paradigm change. There is not that much in it. However, it is very well suited to justify to Jane Doe the enormous investments made in genomics – similar to the teflon-coated frying pan which was used as an excuse for manned space research.” As an example, Grill and Hackenbroch cite a study from 2009 in colon cancer patients, stating that adding Erbitux to the treatment scheme of patients selected by a concomitant Qiagen test resulted in a survival improvement of 4 months: “Is this a medical breakthrough? Is this what progress looks like, bought by spending billions?” Instead, Grill and Hackenbroch recommend spending money on better care at home and better palliative treatment. The article ends with a quote from Wolf-Dieter Ludwig, head of the clinic for hematology, oncology and tumor immunology at Robert-Roessle-Klinik in Berlin: “Up to date, the concept of personalized medicine is an empty promise in the first place.”
Harro Albrecht and Sven Stockrahm in Die Zeit feature the suspicion expressed by medical doctors and competent authorities in the EU that the flu vaccine Pandemrix might cause narcolepsy, in particular in children and young adults. Already, EMEA issued a recommendation to use Pandemrix in children and adults under 20 in exceptional cases only. While there were only two reported cases of narcolepsy among children in the US, there were more than 300 in the EU, with 70% of those cases coming from Scandinavia. Narcolepsy is an autoimmune disease, predominantly in humans with a certain genetic modification, and the authors feature the theory that the adjuvant used in the vaccine might have induced the disease in these patients. However, the genetic variant known does not have a bigger frequency in Scandinavia.
Sven Stockrahm, also in Die Zeit, features miniature, flexible electronic devices that stick to the skin by physical means. They can be hid by a tattoo motif and are able to measure and transmit physiological data for medical purposes. One company developing these devices is mc10 Inc. in Cambridge, Mass.
Martina Lenzen-Schulte in Frankfurter Allgemeine Zeitung (FAZ) gives an overview on the arrival of maggot therapy as a means to clean wounds, stating it has become standard therapy in many German clinics already. Maggots not only remove dead tissue and eschar, they also kill bacteria. Therefore, they are increasingly being used in infections with bacteria carrying multiple resistance to antibiotics. However, maggot therapy is not yet approved in Germany (in contrast to the US).
Sebastian Matthes in Wirtschaftswoche interviews Jackie Fenn, analyst at Gartner and co-author of Gartner’s Hype Cycle Report. Fenn forecasts computers with the ability to understand spoken questions and to put out spoken answers as well as printing of organs and arteries.
Roland Fischer in Neue Zürcher Zeitung (NZZ) looks back at 50 years of the influential Science Citation Index SCI. Originally founded to make the identification of relevant scientific papers easier, it soon became a tool for sociologists of science and led to the birth of scientometry as a new discipline. However, SCI also was used to take quantity for quality, measuring quality of science as number of citations, and it is a well-known episode that in the UK funding of clinical research was cut because preclinical research generates more citations. While this controversy is still ongoing, the taking of quantity for quality is already spilling over into search engines, Fischer describes.
Alex Knapp in Forbes describes a novel approach to broad spectrum antivirals. It is based on a bi-specific drug: one arm binds to double-stranded RNA which is specific for viruses. Once bound, a second arm triggers a mechanism that leads to the destruction of the cell it is in. The experimental drug named DRACO has been successful at eliminating cells infected by 15 different viruses from the common cold to polio in vitro and in vivo (mice).