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

Clinical ResearchFrancePortugalEU

05.02.2016 It is not yet clear why a man died during a first-in-man clinical trial in January. However, a preliminary report found several “major shortcomings” by responsible CRO Biotrial. However, all regulations were complied with.

M&ASwitzerland

04.02.2016 After having dodged multiple takeover attempts by Monsanto last year, agrobusiness giant Syngenta has now agreed to be acquired by chemical corporation ChemChina. The Swiss company also announced plans to go public within a few years.

FinancingEUUKBelgium

01.02.2016 Newly formed Medicxi Ventures, a life sciences-dedicated VC firm based in London, Geneva and Jersey, has closed a €210m investment fund to reinvest in European early-stage assets.

ResearchUKEU

01.02.2016 Altering human DNA with the efficient gene editing method CRISPR/Cas9, especially germline modifications, was long considered a taboo. Now, however, UK scientists have received official approval to tinker with embryo DNA.

M&ASwedenIceland

28.01.2016 Swedish infectious disease specialist Enzymatica has bagged Icelandic company Zymetech, who produces the patent-protected enzyme used in Enzymatica’s own common cold blocker ColdZyme.

R&DUK

27.01.2016 Three UK universities have teamed up with three pharma companies to create the Apollo Therapeutics Fund. With the tech transfer fund, the consortium aims to develop scientific research into medicines.

Clinical TrialsGermany

25.01.2016 Affimed means to put a promising drug combination to the test. With support from MSD, the German biopharma will carry out clinical trials for an immunotherapy combining treatments of both companies.

AMREU

21.01.2016 Stop squandering antibiotics and make research profitable again: at the World Economic Forum in Swiss Davos, 83 pharmaceutical companies have called for a unified approach towards the threat of antimicrobial resistance.

M&AFinland

19.01.2016 Biotie Therapies has long been expanding its business in the US. Now, the Finnish company is set to be taken over by US company Acorda Therapeutics, which is paying €321m for the shares.

Drug AssessmentPortugalFrance

18.01.2016 A Phase I clinical trial for a drug developed by Portuguese pharma company Bial has ended in disaster. One man died, five others may have irreversible neurological damage.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • SAREUM HOLDINGS (UK)0.25 GBP8.70%
  • MAGFORCE (D)5.25 EUR5.00%
  • SUMMIT (UK)4.03 GBP3.87%

FLOP

  • SWEDISH ORPHAN BIOVITRUM (S)12.45 USD-23.38%
  • BIOTIE THERAPEUTICS (FI)0.14 EUR-22.22%
  • EVOCUTIS (UK)0.07 GBP-12.50%

TOP

  • VERONA PHARMA (UK)3.50 GBP32.1%
  • WILEX (D)2.09 EUR22.9%
  • IXICO (UK)34.00 GBP15.3%

FLOP

  • BIONOR PHARMA (N)0.88 NOK-43.6%
  • PROTHENA PLC (IE)34.27 USD-36.4%
  • PLETHORA (UK)2.75 GBP-33.3%

TOP

  • KARO BIO (S)26.80 SEK3728.6%
  • CHRONTECH PHARMA (S)0.34 SEK3300.0%
  • 4SC (D)3.33 EUR291.8%

FLOP

  • NEUROVIVE PHARMACEUTICAL AB (S)8.80 SEK-85.6%
  • BIOTEST (D)14.11 EUR-84.5%
  • EVOCUTIS (UK)0.07 GBP-75.0%

No liability assumed, Date: 07.02.2016