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20/03/2006
Company admits trial drug caused side effects in monkeys
The drug which has left six men seriously ill in hospital during a trial caused glands in two monkeys to swell during earlier tests, it has been revealed.
However, TeGenero, the German company that manufactured the TGN1412 drug, said that the symptoms shown by the monkeys differed from those suffered by the men during the trial last week.
Six men fell ill during the trial of the drug - an anti-inflammatory designed to treat rheumatoid arthritis, leukaemia and multiple sclerosis - at Northwick Park Hospital last Monday.
TeGenero said two of 20 monkeys used in earlier tests in Germany had shown an increase in the size of lymph nodes, but the company said that this information had been given to the men and submitted to the test regulators.
The condition of four of the volunteers from the drug trial is understood to be improving. Doctors at Northwick Park Hospital confirmed that three of the patients had now been taken off organ support. However, two men still remain in a critical condition and doctors said that it was too early to comment on their prognosis.
Two men who participated in the trial were given placebos and suffered no ill effects. In a newspaper interview last week, one of the men described the horrific scenes at the research unit as the other patients began vomiting, fainting and screaming in agony after taking the drug.
The drug trial, which was conducted by American firm Parexel, has been suspended by the Medical and Healthcare Products Regulatory Agency and an investigation has been launched into the testing procedures to see what caused the severe reaction.
(KMcA/CL)
However, TeGenero, the German company that manufactured the TGN1412 drug, said that the symptoms shown by the monkeys differed from those suffered by the men during the trial last week.
Six men fell ill during the trial of the drug - an anti-inflammatory designed to treat rheumatoid arthritis, leukaemia and multiple sclerosis - at Northwick Park Hospital last Monday.
TeGenero said two of 20 monkeys used in earlier tests in Germany had shown an increase in the size of lymph nodes, but the company said that this information had been given to the men and submitted to the test regulators.
The condition of four of the volunteers from the drug trial is understood to be improving. Doctors at Northwick Park Hospital confirmed that three of the patients had now been taken off organ support. However, two men still remain in a critical condition and doctors said that it was too early to comment on their prognosis.
Two men who participated in the trial were given placebos and suffered no ill effects. In a newspaper interview last week, one of the men described the horrific scenes at the research unit as the other patients began vomiting, fainting and screaming in agony after taking the drug.
The drug trial, which was conducted by American firm Parexel, has been suspended by the Medical and Healthcare Products Regulatory Agency and an investigation has been launched into the testing procedures to see what caused the severe reaction.
(KMcA/CL)
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28 March 2006
Drug trial pair released from hospital
Two of the six men who were hospitalised after a drugs trial went wrong have been allowed to return home. Doctors at Northwick Park Hospital said that the two men had responded "very well" to treatment and had made an "excellent recovery". However, four men remain in hospital.
Drug trial pair released from hospital
Two of the six men who were hospitalised after a drugs trial went wrong have been allowed to return home. Doctors at Northwick Park Hospital said that the two men had responded "very well" to treatment and had made an "excellent recovery". However, four men remain in hospital.
16 March 2006
Drug trial men remain seriously ill
Two volunteers who fell ill after participating in the trial of a new drug remain in a critical condition. Six men fell ill after participating in the trial of anti-inflammatory drug TGN 1412 at a research unit at the Northwick Park Hospital on Monday. Four of the men are now understood to be improving, although they are still seriously ill.
Drug trial men remain seriously ill
Two volunteers who fell ill after participating in the trial of a new drug remain in a critical condition. Six men fell ill after participating in the trial of anti-inflammatory drug TGN 1412 at a research unit at the Northwick Park Hospital on Monday. Four of the men are now understood to be improving, although they are still seriously ill.
15 March 2006
Six men hospitalised after drug trial
Six men are in intensive care after falling ill during trials of a new anti-inflammatory drug.
Six men hospitalised after drug trial
Six men are in intensive care after falling ill during trials of a new anti-inflammatory drug.
08 December 2006
Transfusion risk for vCJD 'substantial'
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People given blood transfusions contaminated with the agent that causes variant Creutzfeldt-Jakob Disease (vCJD) are now considered to be at substantial risk.
19 April 2006
Drug trial victims offered £5,000
Six volunteers who participated in a drug trial which left them seriously ill have been offered interim payments of £5,000 if they agree not to sue. Lawyers for four of the six men said that the manufacturer of the drug, TeGenero, had agreed to pay the men compensation on the condition that they accepted a “no-fault” procedure.
Drug trial victims offered £5,000
Six volunteers who participated in a drug trial which left them seriously ill have been offered interim payments of £5,000 if they agree not to sue. Lawyers for four of the six men said that the manufacturer of the drug, TeGenero, had agreed to pay the men compensation on the condition that they accepted a “no-fault” procedure.
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