Tag: Personalized Medicine

Food for Thought: Weekly Wrap-Up

In Frankfurter Allgemeine Zeitung (FAZ), Manfred Lindinger takes up the issue whether nanotechnology poses danger to human health and the environment in an article and an interview with Jochen Flasbarth, president of the German Federal Environment Agency (Umweltbundesamt – UBA). Flasbarth points out that UBA’s nanotechnology study published last year, highlighting gaps in knowledge about potential health hazards, was misunderstood by the media and the public as a sweeping warning of all things nano. He also dismisses calls for introducing a label for products containing nanotechnology: “If there is no risk, we don’t need to put up a warning sign.”

Several German papers feature and discuss an ad-hoc statement on preimplantation diagnosis  issued January 18 by the German National Academy of Sciences Leopoldina and Berlin-Brandenburgische Akademie der Wissenschaften. It was drafted by 13 eminent German academians from biology, medicine, law and philosophy & ethics, among them nobelist Christiane Nuesslein-Volhard. The statement calls for admission of PID under narrowly defined circumstances (high risk of serious monogenic disorder, chromosomal dysfunction, miscarriage or stillbirth). The parliament needs to to regulate PID after the German Federal Supreme Court last year ruled that Germany’s ban on PID was based on misinterpretation of the country’s Embryo Protection Law.

John Tierney in The New York Times provides new insights on people who underwent personal genetic testing to learn about their risk for conditions from obesity to cancer and Alzheimer’s. It is widespread belief among experts and politicians that personal DNA testing needs careful supervision and cannot be offered without expert guidance. The NYT introduces two studies – one follow-up study of about 2,000 people who had a genomewide scan by Navigenics  and one representative sample of 1,500 people – and found that the medical field overestimates the level of psychological anxiety or trauma caused by the results and is way too paternalistic about the tests. One researcher is quoted by saying: “We should recognize that consumers might reasonably want the information for nonmedical reasons. People value it for its own sake, and because they feel more in control of their lives.”

Gardiner Harris reports that the Obama administration has become so concerned about the slowing pace of new drugs coming out of the pharma industry that it has decided to start a federal billion-dollar drug development center. The “National Center for Advancing Translational Sciences” will open in October this year and will beef up early research results by finding leads against new targets or even perform preclinical studies so that projects become attractive to the pharma industry. NIH director Francis S. Collins who is behind the idea, is quoted by NYT as saying: “I am a little frustrated to see how many of the discoveries that do look as though they have therapeutic implications are waiting for the pharmaceutical industry to follow through with them.” In a first step, more than $700 million in research projects from other NIH institutes will be brought together at the new center.

Gina Kolata reports on an FDA advisory committee recommending approval of a new brain scan that can detect the typical plaques in the brains of living Alzheimer disease patients. The test has been developed by Avid Radiopharmaceuticals, now a subsidiary of Eli Lilly (see akampioneer, June 24, 2010).

In the New Scientist, Anil Ananthaswamy features findings from Australian researchers suggesting that Parkinson’s disease, Multiple Sclerosis and maybe other, more common diseases such as rheumatoid arthritis or diabetes, might be cured by antibiotics and subsequent (re-)colonization of the colon with bacteria from healthy people. The hypothesis was derived from case studies of Parkinson’s patients treated for colon infections, in which the treatment also abated the Parkinson’s symptoms. The researchers from the Center of Digestive Diseases in New South Wales are now planning a pilot study in Parkinson’s patients. Already, neuroanatomists from German Ulm University have suggested in 2003 that Parkinson’s might be caused by a bug that breaks through the mucosal barrier of the GI tract and enters the central nervous system via the vagus nerve (Journal of Neural Transmission, DOI: 10.1007/s00702-002-0808-2).

Linda Geddes reports on how cytokines associated with inflammation can enter the brain under certain circumstances and cause depression. Unfortunately, the article fails to mention German biotech company Affectis which already has Cimicoxib, an anti-inflammatory COX-2 inhibitor, in Phase II trials for the treatment of depression, after researchers discovered that COX-2 inhibitors can alleviate depression.

Food for Thought: What Would You Do With a Personal Sequencer?

Basically, it is the smallest pH meter in the world, but its impact on science, medicine, and even daily life is likely to be huge. The pH meter developed by Ion Torrent sits on a semiconductor chip beneath very tiny wells containing a single-stranded DNA probe and DNA polymerase in a buffer. The wells are flooded by the nucleotides A, T, G and C in a sequential manner, and incorporation is recorded by measuring the proton released in the reaction. Thereby, the pH meter can be used to sequence DNA. The chip contains 1.3 million wells, the device measures about 60x50x55 cm (24x20x21 inches), costs $50,000 and is named  PGM – Personal Genome Machine.

Already on the market, it puts DNA sequencing within the reach of nearly every lab, doctor’s practice, clinic, and even college. While it still has certain limitations – it can read only 20 genes at once at present – DNA sequencing never has been easier and less error-prone. Other devices with similar elegance and even more speed are around the corner – as an example, scientists from Imperial College of London last month demonstrated in NanoLetters that they can sequence genes by propelling a DNA strand at high speed through a tiny 50 nanometre (nm) hole cut in a silicon chip, using an electrical charge. As the strand emerges from the nanopore, its coding sequence is read by a ‘tunnelling electrode junction’. This 2 nm gap between two wires supports an electrical current that interacts with the distinct electrical signal from each base code. The speed is unbelievable and translates into sequencing an entire human genome in 5 minutes.

Certainly, these machines will have a huge impact on the amount of data generated for the development of personalized medicine and individualized therapies. But now that DNA sequencing is approaching a mass market, it will inevitably reach anyone, just like cameras, computers and mobile phones that turned from “professional only” machines into commodities. The statement that no one needs such a machine is refuted by history: when the telephone was invented, US president Rutherford B. Hayes could not think of anyone wanting to use it, XEROX once was sure that the world market for photocopiers would be around 50 machines, and even Intel’s founder Gordon Moore could not think of using personal computers at home for anything meaningful other than “maybe filing cooking recipes”.

What would you do with a personal sequencer at home? Screen your blood for disease on a daily basis? Check your food for microbial contamination? Classify the bugs and shrubs in your garden to find new ones? Secretly sequence the DNA of you neighbors, boss or affair to find out about genetic weaknesses? In a decade, ads might state once again: “There is an APP for that!”

Company News: SuppreMol closes C round, receives grant

Munich-based biotech company SuppreMol this month announced the closing of a EUR15.5 M C round as well as receiving a EUR1.6 M public research grant.

The money will be used for the GMP production and further clinical studies of its lead candidate SM101, a recombinant, soluble, non-glycosylated version of the Fc gamma receptor IIb. SM101, which has been granted orphan drug designation in the European Union and in the US, has already entered Phase Ib/IIa clinical studies in Primary Immune Thrombocytopenia (ITP), with interim results anticipated for next year. In addition, the company plans to initiate a Phase IIa study in Systemic Lupus Erythematosus (SLE) mid next year.

Moreover, SuppreMol will explore the therapeutic potential of  SM101 in Lupus Nephritis, a subcategory of this autoimmune disease affecting primarily the kidneys, and evaluate the compound in animal models for the treatment of Chronic Obstructive Pulmonary Disease (COPD). Last not least, the funds will be used for the preclinical development of an anti-FcgRIIb monoclonal antibody, which, due to the different properties of this molecule compared to SM101, may have beneficial therapeutic potential in certain autoimmune diseases.

The C round was led by MIG AG with BioMedPartners AG  as co-lead. The other existing investors Santo Holding GmbH, KfW Mittelstandsbank, Bayern Kapital GmbH and Max-Planck-Gesellschaft also participated in the round which was joined by FCP Biotech Holding GmbH as new investor.

Food for Thought: Why tissue sample quality matters for personalized medicine

“We now have the technical ability to get the wrong answers with unprecedented speed.” Carolyn Compton, Director, Office of Biorepositories and Biospecimen Research

When the U.S. National Cancer Institute recently started its Cancer Genome Atlas initiative and asked biobanks all over the world for cancer biopsy samples, it was puzzled to find that the quality of the donated samples was so poor that the NCI was unable to meet the moderate target of collecting 1,500 biopsy samples per cancer. In a telling article in “Wired magazin”, Steve Silberman gives the example of a university biobank, which claimed to have more than 12,000 samples of glioblastoma in its collection. However, the initiative judged only 18 of those as good enough to use. After contacting biobanks on a global scale, the researchers did not even get to 500 glioblastoma samples of satisfactory quality and barely got to 500 in ovarian cancer, the 5th most common cancer in women. In lung cancer, the initiative was unable to start because it simply could not obtain the minimum number of biopsy samples of adequate quality. „However, all biobanks thought they were doing a superb job,“ resumed Carolyn Compton, director of NCI‘s Office of Biorepositories and Biospecimen Research OBBR and responsible for the biopsy sampling part.
The reason for the poor quality is simple: minutes after cutting tissue off from blood supply, cells start to react with massive changes in gene methylation patterns, gene expression and translation, proteome composition, enzymatic activities, surface protein patterns, etc. The changes affect hundreds of genes, and it is reality in many hospitals that the resected cancer tissue lies around for hours at room temperature in the operation theater before it is put in the freezer to get formalin-fixed a few days later.
Even more, the medication the patient has been given prior to or during operation (sedatives, anesthetics, etc.) has a profound impact on these parameters as well.
Therefore, very often it is impossible to judge whether the changes observed between individual patients is a result of their inherently different metabolisms/genetic makeup or a consequence of different sampling and handling of the biopsies and medications.
“We now have the technical ability to get the wrong answers with unprecedented speed,” Compton says. “If we put the wrong stuff into the front end of our analytical pipeline, we will not only lose the war on cancer, we’ll pollute the scientific literature with incorrect data that will take us a long time to sort out. This is a crisis that requires disruptive innovation.”
OBBR is now systematically looking into the problem and has chosen one company to perform the first systematic studies: Hamburg-based Indivumed GmbH. The company did pioneering research and devised standards for cancer biopsy samplings that are applied in a network of clinics Indivumed is collaborating with in the Hamburg and the Washington DC area. The company runs the only ISO-certified biobank in the world and is offering biospecimens, related patient data, and services including biomarker development for the purpose of developing personalized cancer therapies. By employing specially trained nurses, the company guarantees that each sample is frozen or fixed within 12 minutes, and each sample comes with a data package comprising several hundred data on the patient‘s medical history and life style. Further information about Indivumed, a client of akampion, can be found here.

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