Archive: Company News

Company News: Micromet Initiates Global Phase 2 Trial of Blinatumomab in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia

Micromet, Inc. (NASDAQ: MITI) today announced that it has initiated a phase 2 trial of its lead product candidate blinatumomab (MT103) in adult patients with relapsed or refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.

This phase 2, single-arm study will evaluate the efficacy and safety of blinatumomab in approximately 65 patients with relapsed/refractory Philadelphia-negative B-precursor ALL. Patients will receive blinatumomab daily for 28 days followed by two weeks off blinatumomab over a six week treatment cycle. Patients who achieve a complete remission (CR) or complete response without full recovery of platelets (CRh*) within two cycles of treatment will receive up to three additional cycles of consolidation treatment. The primary endpoint of the study is CR/CRh*. Secondary endpoints include duration of response and overall survival. The study will be conducted at approximately 40 leading cancer centers in the U.S. and EU. The Company currently expects to complete enrollment in this trial by year end 2012.

Additional information regarding this Phase 2 study is available at the U.S. government’s clinical trials database at http://www.clinicaltrials.gov.

Blinatumomab Clinical Experience in Adult R/R ALL

Interim results from a Phase 2 trial presented at the 2011 Meeting of the European Hematology Association show that blinatumomab produced a high CR rate in adult patients with ALL who had relapsed following treatment with standard therapy. 75% of patients (9 of 12) achieved a CR or CRh* following treatment with blinatumomab1. All nine responding patients achieved a complete molecular response, or had no evidence of leukemic cells in their bone marrow, a key prognostic factor for patient survival. Notably, four patients with genetic abnormalities typically associated with poorer outcomes all achieved a CR or CRh*. The most common clinical adverse events were fever, peripheral edema and fatigue. Treatment of two of the twelve patients was interrupted due to fully reversible and manageable central nervous system (CNS) events.

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.

Company News: Keeping an Eye on Curetis

Curetis AG’s latest closing of its series A financing round, which now amounts to a total of €34.1 million, has garnered the attention of many media – in particular, as Roche Venture Funds and Forbion were attracted as new investors.

“With Roche Venture Funds now on board, Curetis may have a leg up in wooing parent company Roche as a commercial partner,” comments Ben Butkus in PCR Insider. Oliver Schacht, CEO of Curetis, is quoted as saying that Roche’s investment came with “no strings attached”, adding that “it is a great sign of validation that, after a lot of due diligence and looking at … our first product, that the PCR multiplexing capabilities that we bring to complex infectious diseases has convinced them, and they made the investment.” Butkus also goes into detail on the technology of Curetis AG’s Unyvero™ System and the roll-out plans for Europe and the US.

The news was also taken up by many other media, including articles in Bloomberg/Businessweek, Dowjones VenturewireMedNous, Genetic Engineering & Biotechnology News, Genome Web, Tornado Insider, IVDT Insight, and transkript – just to name a few.

Already in July, Susanne Kutter had featured Curetis in Europe’s biggest German-language business magazine Wirtschaftswoche in an article on hygiene deficits in German hospitals. In the article, Ingo Autenrieth, Medical Director of the University of Tuebingen’s Institute for Medical Microbiology and Hygiene, underlined that the very important advantage of the Unyvero System is its ability to quickly not only identify a disease-causing pathogen but also the antibiotic resistance genes it carries.

Company News: Gallus Group chooses bubbles & beyond as preferred provider of printing roll cleansers

– Printing roll cleansing agent line enpurex® and surfiMAX cleaning sponges to be distributed with new printers by Gallus Group –

bubbles & beyond, a technology company focusing on customized intelligent fluids®, today announced that the company was chosen as the preferred provider for printing roll cleansing solutions by Gallus Group, St. Gallen, Switzerland. Gallus Group will recommend and distribute selected products of bubbles & beyond´s printing roll cleansing line. Samples of the enpurex® cleansers ONLINE and PRO as well as the surfiMAX cleaning sponges M-ON and M-OFF will be delivered with every printer sold by Gallus Group worldwide and are recommended as the cleansing products of choice.

enpurex® cleansers are designed to meet the criteria of sustainable green printing, while offering significant process cost savings, excellent compatibility of materials, optimum efficacy and operating safety. The cleansers are water-based, non-flammable, free from aggressive chemicals, biodegradable, and also superior to existing products in terms of efficacy. Based on bubbles & beyond´s novel, proprietary intelligent fluids® approach, the products remove all sorts of inks and lacquers used in the printing industry, including 2k lacquer, UV curing ink and calcium glazing, by a unique and fast easy-wipe effect. Thereby, down-time is reduced significantly and printing rolls can be used more versatile across different colors, reducing the need to stockpile print rolls. The enpurex® product line is completed by the surfiMAX cleaning sponges range, which are designed for use in combination with the cleansing agents to achieve optimum results.

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