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Company News: SuppreMol Reports on pre-IND Meeting with FDA

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases, today announced that it has successfully completed a pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead compound SM101, which is being developed for the treatment of Primary Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE).

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: Weekly Wrap-Up

John Markoff reports in the New York Times about scientists who created online video game EteRNA in which players can come up with novel ways of folding RNA. The scientists claim it is “democratizing science” by attracting thousands of citizens to participate in constructing new ways to understand and use the folding of RNA.

Finally, the NYT reports about wine. While archaeologists discovered the earliest winemaking facility of the world in Armenia where wine was being made there as early as 7,400 years ago – proving that mankind must have found something positive in consuming red wine, today’s scientists still grapple at understanding the benefits. Dealing with the halt of the last resveratrol trial in which biotech company Sirtis (now GSK) tried to prove that this particular ingredient of red wine is able to extend the life span of obese Rhesus Monkeys, Nicholas Wade casts doubt about the usefulness of resveratrol and resveratrol-mimicking chemicals as anti-aging drugs.

The Economist this week deals with epigenetics in a story featuring that not only mothers but fathers as well may be able to pass on a propensity to obesity if they themselves have been starved during their life before fathering offspring. The findings are from mice.

A separate story deals with attempts by British researchers to attach glowing proteins to cancer cells so that they emit red light. However to detect it doctors would have to use a specially developed camera that scans the body slice by slice. Such cameras are expensive, and the £500,000 ($750,000) they cost may be the greatest hurdle to deploying the technique.

Djuke Veldhuis reports in New Scientist about a simple blood test for Down’s syndrome that successfully detected all 86 cases confirmed by other methods. The validation study is published in BMJ 2011; 342:c7401.

In The Scientist, Vanessa Schipani elaborates why it is not a good idea to use the usually well-fed, parasite-free and genetically similar lab animals to study immunology. Instead, she makes a case for ecoimmunology, a new field studying immunology in wild animals and still trying to attract more researchers and funding. Jef Akst reports about cancer researchers identifying an increasing number of proteins that have a dual nature in cancer: they may initially promote the development of tumors, but in the long run make them less aggressive, or vice versa. “One problem in identifying such two-faced proteins may stem from the fact that these opposing effects are rarely demonstrated in the same research paper,” Jef writes, adding that both reviewers and funding agencies do not like this kind of complex stories and rather prefer focusing on one side of the coin.

Speaking of peer reviews, Martina Lenzen-Schulte in the German Frankfurter Allgemeine Zeitung (FAZ)  reports about efforts of peer-reviewed journals like the British Medical Journal or the EMBO Journal to make the peer review process more transparent by disclosing the names of the reviewers and the review or even the complete review process. Goals are to improve the quality of the process and of reviews in general and to prevent reviewers from either stealing ideas or putting a spoke in competitors’ wheels.

Volker Stollorz in Frankfurter Allgemeine Sonntagszeitung (FAS) provides a concise review of the ongoing debate whether the chronic fatigue syndrome (CFS) is caused by the newly discovered retrovirus XMRV or whether contamination of specimens, the lab or chemicals used in experiments have produce results that could be mistaken for XMRV. The article clarifies that there are increasing doubts about the hypothesis as many independent researchers have not been able to find the virus in the blood of CFS patients and/or from blood banks.

Focus reports on new efforts to combat AIDS by learning from the about 1% of humans resistant to the virus. The article cites James Hoxie, of Penn Center for AIDS Research, who is trying to cure AIDS by removing from immune cells of AIDS patients those genes that provide entry to HIV. Subsequently, the immune cells are transferred back to the patient. Focus states the approach goes back to findings in Germany at Charité Berlin where a patient suffering from both AIDS and leukemia received a bone marrow transplant from a HIV resistant donor. Citing an article in Blood (DOI 10.1182/blood-2010-09-309591), Focus states the patient is now virus-free and off AIDS medications.

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!”

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