News

Co-stimulators of drug-trial disaster identified
Enlarge image

BusinessGermany

Co-stimulators of drug-trial disaster identified

14.05.2012 - German researchers found a potential co-factor that triggered the cytokine storm, which led to hospitalisation of six volunteers treated with TGN1412.

Langen – A team of German researchers from the Paul-Ehrlich-Institut (PEI) has identified an important mechanism that can explain how immunotherapy drug TGN1412 might have triggered the catastrophic immune reaction responsible for the 2006 Northwick Park trial. The drug-trial disaster left six healthy volunteers hospitalised. The team, led by Zoe Waibler, reports that TGN1412-mediated T cell proliferation and cytokine release triggered by the superagonistic CD28-specific antibody, requires an interaction of an inducible co-stimulator on T cells (ICOS) with its ligand on endothelial cells (LICOS).  The team reports in the journal Blood. "We found that co-stimulatory ICOS-LICOS interaction between T cells and endothelial cells is critically involved in TGN1412-mediated effects."

The Phase I clinical trial of TGN1412 took place at an independent clinical trials unit at Northwick Park and St Mark's Hospital, London, on 13 March 2006. TGN1412 was intended for the treatment of leukaemia, multiple sclerosis and rheumatoid arthritis. Eight volunteers were given the drug or a placebo by intravenous infusion, with an interval of about 10 minutes between patients. Within minutes of the last patient being administered the drug, the first began to complain of headache, followed by fever and pain. The five other patients to receive TGN1412, as opposed to the placebo, became seriously ill soon afterwards. All six male volunteers experienced cytokine release syndrome (cytokine storms) with effects similar to those of people suffering a severe allergic reaction. Each of the men was hospitalised for several weeks, with the worst affected requiring hospital treatment for four months.  The drug developing company, TeGenero Immuno Therapeutics from Germany, entered into insolvency proceedings later in 2006. It assets were sold to German-Russian Theramab LLC, which develops TGN1412 under the new name TAB08 as therapy for B-cell chronic lymphocytic leukaemia and rheumatoid arthritis.

http://www.european-biotechnology-news.com/news/news/2012-02/co-stimulators-of-drug-trial-disaster-identified.html

RegulationEU

21.01.2015 The EMA is asking for comments on how to implement the transparency rules of EU Clinical Trial Regulation, pointing to the new clinical trial portal and database as the main instrument.

Stock marketsEUGermany

21.01.2015 2014 was a record year for biotech companies on the European stock market, with a total of €2.4bn raised in the year - 25% more than in the year before.

ResearchEUUK

20.01.2015 Ebola research projects are set to receive €215m in funding from the European Commission’s IMI2 Ebola+ programme. Among the project partners are vaccine developers Glaxosmithkline, Johnson&Johnson and Merck. 

Stock ExchangeUKDenmarkFrance

16.01.2015 It's time to get used to weekly IPO plans by European biotechs. UK's drug discovery firm Redx Pharma Ltd, established just five years ago, has come of age with their £80m (€105m) IPO plans.

M&ASwitzerland

14.01.2015 Pharma kingpin Roche has launched a billion-dollar transaction for a total of US$1.2bn (€1bn), taking over the majority of US cancer specialist Foundation Medicine.

PoliticsEU

14.01.2015 The European Parliament has backed the legislation allowing individual countries to restrict or prohibit the cultivation of genetically modified crops that have been authorised at EU level.

M&AIrelandUK

13.01.2015 Shire beefs up its rare disease portfolio after acquiring NPS Pharma with the aim of becoming a leading biotech in a US$5.2bn deal. Part of the deal is the US biotech's lead portfolio of gastrointestinal and hormone replacement therapies.

M&ASwitzerlandFrance

09.01.2015 The excitement surrounding CRISPR genome editing shows no sign of abating. This month, Novartis and US biotech Intellia Therapeutics became the first ever biotech-pharma collaboration to use the groundbreaking technology.

PoliticsBelgium

08.01.2015 Belgian cell therapy specialist Cardio3 Biosciences joins the immuno-oncology arena with the acquisition of Celdara Medical's cancer division Oncyte for US$180m.

PoliticsIrelandEU

06.01.2015 With the aim to utilise Ireland’s many natural resources and keep abreast of the latest EU developments in bioeconomy, a multi-disciplinary team has been funded to maximise national income, exports and job creation related to Ireland’s bioeconomy.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • CYTOS0.39 CHF21.87%
  • THERAMETRICS0.07 CHF16.67%
  • SANTHERA97.50 CHF5.98%

FLOP

  • 4SC0.78 EUR-8.24%
  • ADDEX3.36 CHF-5.62%
  • BIOFRONTERA1.95 EUR-2.50%

TOP

  • CYTOS0.39 CHF77.3%
  • ADDEX3.36 CHF44.2%
  • BB BIOTECH253.50 EUR28.1%

FLOP

  • ACTELION99.25 CHF-16.3%
  • BIOFRONTERA1.95 EUR-15.2%
  • 4SC0.78 EUR-13.3%

TOP

  • SANTHERA97.50 CHF2355.9%
  • BB BIOTECH253.50 EUR110.1%
  • FORMYCON12.40 EUR60.0%

FLOP

  • CYTOS0.39 CHF-88.1%
  • 4SC0.78 EUR-51.6%
  • MOLOGEN5.79 EUR-50.1%

No liability assumed, Date: 26.01.2015