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Company News: SuppreMol Starts SM101 Dosing in the Context of SMILE Study

– Australian study center treats first systemic lupus erythematosus (SLE) patients –

SuppreMol GmbH today announced the start of dosing in the context of the international SMILE study (SM101 In Lupus Erythematosus). The phase IIa, double-blind clinical trial of SM101, the lead compound of the company, involves patients suffering from Systemic Lupus Erythematosus (SLE).

The first patient was treated last month in Australia. Additional study centers in Belgium, Germany, France, Great Britain, Italy, the Netherlands, Poland, Spain, and the Czech Republic will commence patient treatment in the coming weeks. Over the course of one month, the study participants will receive placebo or two different doses of SM101 weekly.

SM101 is a soluble version of the Fc gamma receptor IIb, which binds to autoantibody/autoantigen complexes and thereby blocks the triggering of Fc receptors on the surface of immune cells.  SM101 has been studied in the context of a clinical phase Ib/IIa trial for the indication of Primary Immune Thrombocytopenia (ITP) since 2010. For this indication, the product is designated as a drug for rare medical conditions (“orphan drug”) in the European Union and in the United States.

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Food for Thought: Trade Media Update

MedNous this week opens up with an article on FDA’s revoking the breast cancer indication for Avastin, saying that the decision did not come as a surprise after the FDA’s Oncologic Drugs Advisory Committee (ODAC) in June voted unanimously to have the indication removed. Avastin had been subject to FDA’s accelerated approval process in this indication.

In contrast, BioCentury Extra reports that FDA encouraged Genentech Inc to continue to study the drug in this indication to identify patients who may benefit and also details Genentech’s plans for Avastin in this indication. It also writes that in the previous months, the National Comprehensive Cancer Network (NCCN) continued to recommend Avastin as an option in breast cancer despite the negative ODAC vote.

The In Vivo Blog comments on the Avastin decision by saying that it introduced some predictability into the accelerated approval regulatory pathway. Companies should continue to use progression-free survival as a surrogate endpoint but not forget to that FDA has some expectations, e.g. for quality of life benefits, and that sponsors should design trials with supportive measures that can themselves turn into additional claims.

BioCentury this week in its cover story reports on the next-generation, interferon-free treatment regimes for HCV which have been in the focus of the recent Liver Meeting of the American Association for the Study of Liver Diseases (AASLD), stating that the new standard of care introduced only this year  following the approval of two HCV protease inhibitors, may be supplanted quickly by new regimes that are tailored to virus subtypes and patient populations.

SciBx is focusing on novel small molecule inhibitors of Monoacylglycerol lipase (MAGL), which regulates the levels of several compounds that signal through the endocannabinoid pathway. However, now that researchers have shown that it MAGL inhibitors reduce neuroinflammation, there is increased interest in the industry in these inhibitors. MAGL also is explored as a cancer target as reported by Derek Lowe in its “In the Pipeline” blog.

SCRIP this week deals with plans of the French health ministry to collect more than €290 million for the pharmaceutical industry in 2012 to reduce health care spending. In addition, it reports on plans to widening the tax on pharmaceutical industry promotion.In its editorial, SCRIP focuses on German media trying to scandalize the deaths attributed to Boehringer Ingelheim’s Pradaxa drug (see the akampioneer).

Food for Thought: Weekly Wrap-Up

Clemens Gleich in Die Welt reports on the development of super batteries able to power a smart phone or notebook for days without re-charging. While some researchers try to improve conventional lithium-ion batteries by modifying the carbon-based anode with silicon, others design lithium-oxygen or fluorine-oxygen batteries. Main challenges are safety, prevention of swelling and maintaining a high capacity.

Britta Verlinden in Die Zeit reports on the discovery that dimethyl fumarate, a standard drug used for the treatment of psoriasis since 1994, may also be used as a pill to treat multiple sclerosis. Preliminary results of a Phase III trial demonstrate its ability to significantly reduce the number of attacks. The drug candidate codenamed BG-12 is being developed by Biogen Idec. The paper raises the concern that BG-12 may be sold as MS medication at €15,000 a year – while based on the price of the same compound for psoriasis, costs would amount to €4,400 per year, which already “is clearly more costly than what might be expected based on the cheap basic material”.

The Economist this week features the discovery of Oxford University scientists that a small marine organism produces a water-resistant, flexible material which has the adhesive characteristics of barnacle glue and the structural properties of spider-silk fibres. Already, spider silk is being used for novel materials. A salt water tolerant silk might open up medical uses for silk where it would come in contact with salty body liquids. The paper also looks into the prospects of stem cell therapies. While Geron’s pulling out of the stem cell business is viewed as bad news for the field, the paper highlights good news coming from a Lancet paper describing how stem cells can be used to repair hearts. The injection of autologous heart stem cells into damaged heart muscles of patients which underwent coronary bypass surgery led to “remarkable” results, improving pumping volume and other parameters.

Linda Geddes in The New Scientist raises hopes that partial wave spectroscopic (PWS) microscopy some day may be used to screen the general population for diseases like cancer, Alzheimer’s Disease or autoimmune diseases. PWS microscopy can detect changes in the chromatin density of cells, and researchers already have shown that cancer patients even in apparently healthy cells have unusual chromatin densities not seen in cancer-free people.

Finally, Alex Knapp in Forbes proclaims the end is in sight: we may be approaching the day where coffee is both rare and expensive. For one, the demand is growing all over the world at an enormous rate, and second, at the same time yields are diminishing because of pests, climate changes and political instabilities. So enjoy your coffee while it lasts!

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