Tag: autoimmune disease

TolerogenixX Receives Approval to Start Phase IIb Trial for its Immune Tolerance-Inducing MIC-Lx Cell Therapy

— Multi-centric clinical study in patients with stage 5 chronic kidney disease (CKD) receiving a living donor kidney

— Study of MIC-Lx cell treatment, a potentially curative approach to achieve sustained immune tolerance in transplanted and autoimmune patients as shown in previous Phase Ib study

TolerogenixX GmbH, a biopharmaceutical company developing personalized cellular therapies aimed at achieving sustained immune tolerance to combat organ rejection and autoimmune diseases, today announced that the German regulatory authority Paul-Ehrlich-Institut has approved a Phase IIb clinical trial for TolerogenixX’s MIC-Lx cell therapy designed to induce immune tolerance. Read more…

Innovation Radar: How to Detect Increased Risk for Renal Manifestations in SLE (lupus) patients

Patients suffering from the autoimmune disease systemic lupus erythematosus (SLE) develop autoantibodies to chromatin and often to neutrophil proteins as well. As immune complexes of these antibodies can be deposited in kidneys, they contribute to the frequent and dangerous organ manifestation of lupus nephritis.

Recent studies suggest that neutrophil extracellular traps (NETs) might act as a source of autoantigens. NETs consist of chromatin as well as granule proteins and play an important role in immune defense after their release from neutrophils to sites of infection. Degradation of NETs is mainly promoted by DNase1 digestion which is impaired in a subset of SLE patients. A strong correlation between NET degradation status and lupus nephritis, e.g. glomerulonephritis, has been shown and therefore offers a new diagnostic method for detecting an increased risk of SLE patients to develop renal manifestations.

Based on these observations, scientists of the German Max Planck Society (MPG) have developed a technology for the assessment of an increased risk in SLE patients for developing renal manifestations – a finding that is not achieved by determination of anti-dsDNA antibody titers.

The technology measures a NET-degradation status upon incubation with a sample of body fluid (e.g. blood or serum) from a SLE patient, whereby a poor NET-degradation corresponds to a higher probability of developing renal manifestations. Protocols for obtaining NETs from healthy donors as well as preparing NETs artificially are provided. Degradation status is assessed by determination of released/present NET-component(s) (e.g. neutrophil elastase) after incubation with a sample from a patient and either by comparison with the results obtained from a healthy donor or a control sample (buffer). Determination of NET-degradation can be achieved by the use of fluorescence spectrometry, ELISA or EIA. An international patent application has been filed.

The technology is available for licensing via Max Planck Innovation.

 

Food for Thought: Weekly Wrap-Up

Dieter Durand and Susanne Kutter in Wirtschaftswoche feature a disputation between Alzheimer-researcher Konrad Beyreuther and author Cornelia Stolze, who has written a book claiming Alzheimer’s disease does not exist as an exactly defined disease.

While Beyreuther maintains the disease is real and can be clinically separated from other forms of dementia, he concedes that current medications are useless and that diagnosis often is inadequate. Stolze in her book “Vergiss Alzheimer” (“Forget About Alzheimer’s”) states that patients with signs of dementia often are labeled as Alzheimer’s disease patients although they are not, that they receive useless medications, that the real causes of their respective dementias, such as diabetes, depression, stroke, or dehydration, are overlooked and not treated, and that medical doctors make money with unreliable early diagnostic tests. A review of the book is to follow soon – please regularly check the akampioneer.

Joachim Müller-Jung in Frankfurter Allgemeine Zeitung (FAZ) comments on a proposal by several US stem cell researchers in the “Cell Stem Cell” journal. The manifesto calls for establishing a market for human donor egg cells so that scientists can use these cells for cloning experiments. While the purpose is not cloning humans but generating pluripotent human stem cells, Müller-Jung warns that the push will once again put the “cloning humans” debate on the table – a discussion he thinks is needed like a hole in the head. He states there are plenty of experiments already demonstrating that sooner or later it will be possible to generate pluripotent human stem cells for regenerative medicine by reprogramming human body cells.

Martina Lenzen-Schulte, also in FAZ, features the first attempts to use the mirror neuron concept for clinical purposes, e.g. for the rehabilitation of stroke patients to support regain of movement control.

Hildegard Kaulen in FAZ reminds her readers that a substantial part of the research crowned by nobel prizes never received third-party funds. She expresses sympathy with the proposal put forward in “Nature” by Stanford University’s John Ioannidis to either allocate research grants by lottery, by dividing up the money so that each applicant receives the same amount, or simply by handing out money to outstanding scientists with the only specification to use it for research. He criticizes that it has never been investigated which method to allocate research grants is the best and that the current practice consumes too much valuable time that should be spent more creatively on research.

Die Welt reports in a feature by dpa on material scientists of the Technical University Dresden who use wood for pipes that are as strong and resilient as pipes made from concrete. Wood is cut to rectangular blocks, which are heated to 140°C and compressed. Subsequently, all air – which amounts to up to two third of the wood’s volume –  is removed. The resulting panels are then bonded and formed by applying steam. The team led by Peer Haller of the university’s Institute for Steel and Wood Construction calculates that a post carrying 50 tons of weight needs 155 kg of steel but only 28 kg of wood treated with the new procedure.

Katrin Blawat in Süddeutsche Zeitung (SZ) reports that Umckaloabo, an alcoholic extract of Pelargonium sidoides roots, is under investigation by Germany’s Federal Institute for Drugs and Medical Devices (BfArM). The medication, which is sold as OTC in Germany for the treatment of acute bronchitis (with annual sales of about € 40 million), is suspected to cause inflammation of the liver, with six cases reported in 2011.

The New York Times (NYT) this week deals in-depth with the recommendation of the United States Preventive Services Task Force that men no longer should have an annual prostate-specific antigen (PSA) test. Gardiner Harris interviewed the experts involved in reviewing PSA testing, citing Dr. Roger Chou, an associate professor of medicine at the University of Oregon, as saying “the idea that knowing you have a cancer isn’t always a good thing is a very difficult concept for many people.” Chou states that the vast majority of men who have prostate cancer will never be bothered by it. Urologists however view the issue differently, stating the task force chose to focus on the wrong studies and it was wrong to throw PSA testing away.

Last not least, in preparation of the coming common cold season, Ulrike Gebhard in Neue Zürcher Zeitung (NZZ) explains that men suffer from the common cold more often than women. Reason is – according to researchers from Belgian Gent University – that women often carry extra portions of genes from the toll-like receptor (TLR) gene family. As a result, they produce more of the so-called miRNA molecules that support the body in fending off viral infections. The downside of women’s more powerful immune system is increased susceptibility to autoimmune diseases and a more violent reaction to certain vaccines.

Company News: SuppreMol Receives U.S. Orphan Drug Designation for SM101

SuppreMol GmbH, a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases, today announced that the FDA’s Office of Orphan Products Development has granted Orphan Drug Designation (ODD) for SuppreMol’s lead product SM101, a recombinant human soluble Fcγ receptor IIb, for the treatment of Idiopathic Thrombocytopenic Purpura (ITP).

At present, SM101 is in a Phase Ib/IIa clinical study in ITP, with results expected in early 2011. For the same indication, the molecule has already been granted Orphan Medicinal Product Designation in Europe by the EU Commission in 2007. Further details are available on the company’s website.