GermanyGermany

Micromet’ s blitumab meets study goals

15.06.2010

Martinsried/Bethesda – Micromets bifunctional monoclonal antibody drug blinatumomab (MT103) has met its study goals in two independent clinical trails. In a Phase I dose escalation study in 52 adult patients with relapsed non-Hodgkin's lymphoma (NHL), the BITE antibody which activates T- killer cells against tumour cells, achieved an objective response rate of 100% (8 of 8 patients) at a once daily dosage of 60µg/sqm. The median response duration was 21 months. However, in a sub-group of patients with an identified prognostic factor, Blinatumomab induced neurologic events that led to study discontinuation. This was avoided when starting with a low dosage of 15µg/mg ("step-dose approach"), with no grade 3 or higher neurological events occurring and five objective responses being achieved among the six patients treated with MT103. In a Phase 2 trial in adult patients with minimal residual disease (MRD) in positive acute lymphoblastic leukemia (ALL), Blinatumomab achieved 1st primary endpoint of MRD response. Of 20 evaluable patients, who received 15µg/sqm, 80% (16 out of 20) achieved a complete MRD response. Key secondary endpoints included time to hematological relapse, time to molecular relapse and overall incidence and severity of adverse events. Based on the results reported to date in ALL, Micromet plans to initiate a pivotal, non-randomized, multi-center trial intended to confirm the efficacy and safety of blinatumomab in adult patients with B precursor ALL with minimal residual disease after treatment with front-line chemotherapy. Patients will receive 15 micrograms per meter squared per day of blinatumomab for 28 days followed by two weeks off therapy over a six week treatment cycle. The primary endpoint of the study is MRD response as assessed by PCR analysis. The key secondary endpoint is time to hematological relapse (for non-transplanted patients). The Company currently plans to enroll up to 130 evaluable patients at approximately 70 leading cancer centers in Europe and the U.S.


GermanyGermany

07.03.2012

The first of February marked a milestone for Leverkusen-based Bio­frontera AG in more ways than one. It was the first day that Ameluz, the firm’s first approved product, could be sold in German pharmacies. It was also the date...

GermanyGermany

07.03.2012

Darmstadt – German pharmaceutical and chemical company Merck KGaA has set a downbeat tone for 2012. CEO Karl-Ludwig Kley said the recently launched cost-cutting programme and tough economic conditions will weigh on profits this...

GermanyGermany

05.03.2012

Mainz/Leuna – Two biotech concepts were amongst the winners of the recent third round of the Excellence Cluster initiative, which is funded by the German Ministry for Research. In Mainz the champagne corks popped especially loud...

GermanyGermany

05.03.2012

German Merck KGaA has closed a licencing agreement with US-based Threshold Pharmaceuticals Inc. The cooperation centres around the hypoxia­-activated drug TH-302, which is currently being studied in a global Phase III study....

GermanyGermany

29.02.2012

Munich – Looking back with satisfaction and bent on a prize for good behaviour, German biopharmaceutical company Wilex AG reported yesterday on the fiscal year 2011 and outlined the shores in sight. The 2011 total revenue was...

GermanyGermany

17.02.2012

Brussels – European cartilage researchers intensify their cooperation. The 'gristle network' comprises scientists from Belgium, France, Germany and Luxembourg. Its members plan to meet regularly to exchange views and information...

27.01.2012

Thousand Oaks/Munich - Bling bling for blinatumomab. It is a compliment for the European life sciences scene and sad news at the same time. Amgen Inc., the world's largest biotechnology company, agreed to buy Micromet Inc., an...

GermanyGermany

20.01.2012

Martinsried - SHELTER is responsible for the fact that the stocks of 4SC behaved like a rodeo horse on Thursday. The shares rose in several stages up to 63%, only to settle at a mere 43% rise at the end of the day. SHELTER is a...

GermanyGermany

17.01.2012

Ludwigshafen – BASF Plant Science GmbH, the agrochemistry and biotech arm of the world-largest chemistry company, thinks that it has outstayed its welcome in Europe. Over the next two years, most of the green biotechnology...

GermanyGermany

10.01.2012

Munich - It is the accolade for Micromet. The German company, which is listed on the U.S. stock exchange, announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the renowned US...

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No liability assumed, Date: 23.04.2014

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