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Company News: SuppreMol Employs Protagen Biomarkers in SLE Study

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases and allergies, and Protagen AG, a specialist in in-vitro diagnostics and GMP-compliant protein analysis, today announced a collaboration to identify therapy-related biomarkers in patients with Systemic Lupus Erythematosus (SLE).

SuppreMol will use the biomarkers for the rapid identification of autoantibody signatures in the serum of SLE patients enrolled in the current phase IIa study of its lead product SM101. Thereby, the company hopes to identify patients who are most likely to respond favorable to SM101. Since SLE is a disease with very diverse manifestations, the findings may also allow for the classification of patients into subgroups .

Financial details of the collaboration are not disclosed. The cooperation as well as SuppreMol’s phase IIa SLE study are supported by the German Federal Ministry for Education and Research (BMBF) as part of the Leading Edge Cluster m4.

Food for Thought: Weekly Wrap-Up

The EHEC epidemic in Germany with 4,300 patients and 50 deaths has changed the way public health institutions will deal with future epidemics, writes Christina Hucklenbroich in Frankfurter Allgemeine Zeitung (FAZ). She cites microbiologists involved in the rapid sequencing of the EHEC strain who think that the epidemic gave birth to the new discipline of “prospective genomic epidemiology”. To date, sequencing has been performed retrospectively only. However, using the novel Ion Torrent PGM HGS platform, scientists from the University of Münster were able to sequence the EHEC strain responsible for the outbreak within 62 hours. The scientists now think of a software generating a plain language report interpreting the genome and analyzing for toxins and antibiotics resistances of the germ in question so that immediate therapeutic and prophylactic consequences are possible.

Gas, electricity and hydrogen from algae are in the focus of a story by Susanne Kutter in Wirtschaftswoche. She features Sven Kerzenmacher and Johannes Gescher from the University of Freiburg and their efforts to produce electrical current directly from bacteria. The technology is based on the Shewanella bacterium which can transfer electrons generated by breakdown of sugar or other nutrients from the cell surface to conductive materials. Shewanella lives in fresh-, brack- and seawater and thrives on organic waste. The researchers are now trying to design a Shewanella-based mini-powerplant the size of a refrigerator which is able to produce 5-10 Watts of electricity per day – sufficient to meet the demand of a four-person household. Among others, Kutter also features a dual-chamber solar module developed by researchers from Leipzig, Karlsruhe and Bremen. In the first chamber, algae are forced by an excess of oxygen to produce hydrocarbons (“photorespiration”). The hydrocarbons enter the second chamber via a membrane and are used by bacteria to produce methane under anaerobic conditions. Readers interested in learning more about Shewanella may find regular updates on Shewanella Blogger.

While algae seem to be an ideal biofuel replacement for gasoline in the first place, it has turned out that the economics is a problem, writes Erica Gies in Forbes. Gies revisits former biofuel-from-algae startups that are now turning to more profitable products, using “green” chemistry to replace petrochemicals or unsustainable bio-based oils.

Also in Forbes, Matthew Herper deals with an op-ed in Nature Reviews Drug Discovery by John L. LaMattina, ex-CEO of Pfizer, Inc. LaMattina writes the pharma’s M&A activities have had a “devastating” effect of research and development efforts which will impact the industry over the next decade. The comment is all the more telling as LaMattina was pivotal in Pfizer’s acquisitions of Warner-Lambert, Pharmacia, Wyeth and many other companies. LaMattina summarizes that the consolidation by M&A led to fewer companies pursuing novel ideas and disruptions in research processes. Friction is caused, among others, by the need to streamline computer systems, procedures to track side-effects and others. Usually, a merger delays the start of any new research project by nine months. LaMattina’s comment can be accessed here.

Brandon Keim in Wired explains that most genetic differences in people are not caused by mutations but by variations in the genome’s architecture. At present, sequencing is designed to identify SNPs and as every sequencing method is breaking down the DNA in smaller pieces most genomic studies a blind to larger variations. First sequencing studies looking at larger DNA pieces now revealed that individuals seem to be distinguished less by their SNPs than by their structural variations, i.e. wholesale duplications and reversals, or unexpected additions and omissions of long DNA sequences.

Finally, Catherine de Lange in the New Scientist features the first car plugging into the driver’s brain to cut response times in case the car needs to stop suddenly. The invention of Stefan Haufe from the Berlin Institute of Technology uses an EEG headset and sensors on the leg to detect neuronal patterns and muscle tension to find out that the driver intends to apply the brakes. The system improves response times by 130 milliseconds which translates into the length of a small car when stopping from a speed of 100 km/h.

Food for Thought: IQWiG Updates Report on Alzheimer Drugs

Galantamine and transdermal rivastigmine plaster can delay loss of cognitive function in Alzheimer’s disease (AD) patients, Germany’s Institute for Quality and Efficacy in Health Care (IQWiG) said in a preliminary report published on its website. In 2007, IQWiG had issued a negative report on the benefit of donezepil, galantamine and rivastigmine, however in 2009 the institute initiated an update, adding additional published and unpublished studies for the appraisal of galantamine and including the rivastigmine plaster which entered the German market in 2007.

IQWiG now states that galantamine at higher doses has a positive effect on cogitation and retentiveness of female patients with mild and moderate AD. However, it added that there was no evidence of improvement of daily routine abilities or psychopathological symptoms such as unrest and depression in both male and female patients. In addition, IQWiG notes that patients often dropped out of the study because of side effects such as nausea, vomitus or diarrhea. It also states that it did not find evidence supporting a galantamine treatment for more than 12 months.

For the rivastigmine plaster, IQWiG said it found hints that the 10 square centimeter plaster improves cognition of patients under 75 years of age; however it states that the data were not resilient enough to support an assessment as “proof of efficacy.”

IQWiG said that both manufacturers, the pharma companies Janssen-Cilag and Novartis, provided all study data requested by IQWiG, including unpublished data comprising 48% of study patients. Juergen Windeler, head of IQWiG said in a statement that this was further underlining the necessity to introduce mandatory publication of clinical study data.

 

Food for Thought: Weekly Wrap-Up

Andreas Sentker in Die ZEIT takes up the issue of rising eco-terrorism in Germany directed against field trials of genetically modified plants. These plants are an easy target as trial sites have to be disclosed to the public in registers following legislation initiated by the former red-green coalition in Germany. While in the past years opponents of genetically modified plants only targeted the plants they dub as “Gen-Dreck”, violence is now also directed against security firms and guards watching the fields. Last week, a masked gang assaulted security guards, looted their mobile phones and destroyed different plants of research projects from the University of Rostock. The plants were carrying genes for the production of biopolymers and for a vaccine against viral diseases.

In Süddeutsche Zeitung (SZ), Hanno Charisius introduces efforts to create artificial leaves mimicking photosynthesis to create hydrogen which can be used as fuel or energy source. Daniel Nocera from the Massachusetts Institute of Technology (MIT) is just using the principle: water molecules are split using electrical current produced by solar cells – an ages-old principle. Noceras new twist, however, is the use of a mix of cobalt and phosphate as a catalyst. The mix is accumulating at the electrodes, but after a while it is crumbling and thereby regenerating. The reaction is not the most effective one, but prototypes are already running for months without efficiency drop. First machines will now be installed in India for tests in realistic  conditions; the goal is to meet the daily power demand of an Indian family by using just 4 liters of water and sunlight. Nocera is now trying to combine his catalyst with solar cells to a single device.

Katrin Blawat, also in SZ, in a somewhat pessimistic article deals with the many failures to develop a drug to combat Alzheimer’s disease. Given that there are neither cures nor effective therapies to prevent or delay the onset of AD, she cautions against tests for early diagnosis.

Another negative outlook is given by Werner Bartens in the same paper. Bartens deals with personalized medicine, calling the concept a “set phrase” invented to disguise that personalized medicine is a mere “PR strategy by the pharma industry and stakeholders from academia” invented to lay a smoke screen on the failure to develop new blockbuster drugs. For Bartens, the “niche buster concept” is “science fiction” allowing the pharma industry to obtain approval without any proof of patient benefit. As an example, Bartens interestingly mentions the introduction of personalized cancer drugs of which only a fraction of the patients is benefitting.

In contrast, Ronald D. Gerste in Neue Zürcher Zeitung (NZZ) writes about how cancer patients have profited from targeted therapies, e.g. in terms of decreasing cancer mortality and improved survival. Gerste features a trial by the MD Anderson Center in Houston/Texas in which 460 cancer patients underwent detailed molecular genetic analysis. Subsequently, they were treated by a matching therapy addressing the most promising molecular mechanism. Without applying any experimental drugs, this procedure increased survival from 9 to 13.4 months on average.

Also in NZZ, Stefan Betschon makes the case for better science communication, introducing an article by Dirk Helbing and Stefano Bialetti on “how to create an innovation accelerator“. They propose to improve the academic publication system by publishing articles ahead of peer review finalization and call for review by crowd sourcing. Rejected publications should also be made public, alongside with comments.

The Economist this week casts doubt on whether the goal to eradicate polio by the end of 2012 can be met. The disease is still endemic in four countries (Afghanistan, Pakistan, India and Nigeria), however re-emerged in African and Asian countries in recent years. Reasons are political (war, refugees, etc.), socioeconomic (poor sanitation) and medical (vaccines needs cold chain, virus can hide in asymptomatic carriers) factors.

Another article in The Economist deals with epigenetics findings by a German research group from the University of Konstanz. The team found that stress during pregnancy (abuse, violence, famine, death of a relative etc.) can lead to a change in the DNA methylation patterns of the unborn child, e.g. of the gene coding for glucocorticoid receptors which relay signals from stress hormones in the blood to cells of the brain regions controlling behavior. The findings may explain why children of stressed mothers show higher-than-normal rates of psychological and behavioral disorders and may lead to insights about how and when interventions are possible and promising.

Andrew Pollack in the New York Times features discussions on changing the rules for research in human subjects. The US government claims that changes are needed in the light of genomics studies using patients’ DNA samples, the use of the Internet and a growing reliance on studies that take place at many sites at once. Among the proposed changes are adding informed consent rules to donors of blood, DNA or tissue samples and allowing a single institutional review board for multiple-site clinical studies.

And finally, for all of us struggling daily with the touchscreen keyboards of our iPads and iPhones, IBM comes with a solution: a keyboard that morphs to fit an individual’s finger anatomy and typing style. Paul Marks in Wired dug out an IBM patent describing keyboards in which buttons are automatically resized, reshaped and repositioned according to the users typing style.

 

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