TeGenero, a German based drug firm that had manufactured TGN-1412, has now admitted that the drug had showed adverse effects//, when tested on monkeys. Four out of the six who were admitted to the intensive care unit of a London based hospital following the drug administration are recovering, according to official reports.
The controversial clinical trial had been conducted at Northwick Park Hospital in Harrow, London. Two of the six volunteers are still under a critical condition. Organ support is being provided to two other study participants. The rest two are off their support systems.
In a pre-clinical trial that involved animals, two monkeys have been reported to develop lymph node inflammation following injection of the experimental drug. The company in response to the above issue has however said that symptoms experienced by the man had no correlation with that documented in monkeys.
'There were adverse effects in a certain dosage. Some of the monkeys developed an increase in the lymph nodes,' said Prof. Johannes Loewer, President, Paul Ehrlich Institute.
The drug company had previously claimed that there had been no drug-related adverse effects. Furthermore, the study participants were told that there had been no instances of adverse effects in the prior tests. The side effect of the drug as seen in monkeys had been high enough to warrant monitoring of the immune system and function in human volunteers.
A previous study conducted in 2002 had warned about the possible risks associated with TGN-1412, much earlier. Human cells subjected to treatment with the drug under experimental conditions were found to suffer a significant level of damage.
Health officials have now questioned how the British authority, could have approved of the human clinical trials of the experimental drug despite the known health hazard. 'We assigned expert assessors to review the original decision in approving the cli
nical trial and we found nothing that would question our decision,' said Silke Thomson, spokeswoman, Medicines and Healthcare Products Regulatory Agency, in a response statement.
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