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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (19295)	3/15/2006 1:43:56 PM
From: Biomaven	Read Replies (1) \| Respond to of 52153

Thanks for the comment - I'm out of my depth here. Just based on the fact that there are multiple subjects involved I'd have to guess that a delayed reaction is more likely - seems like they wouldn't (shouldn't) dose everyone at once, and so a quick reaction should be enough to give them warning before the next subject. CTLA4-Ig might be an interesting treatment if this in fact is what's going on. Peter

To: scaram(o)uche who wrote (19295)	3/15/2006 1:56:29 PM
From: zeta1961	Read Replies (1) \| Respond to of 52153

One patient got sick within 3 hours according to this report..this and bio-krunchers post leave me even more hopeful Ryan Flanagan, a 21-year-old student, was taken to intensive care three hours after taking the tablets, the Sun reported. His family was told he could not breathe and his head and neck had swollen considerably guardian.co.uk Two men are in a critical condition and four are seriously ill after suffering an extreme reaction to a drug during a trial. The six men are in an intensive care unit at Northwick Park hospital, in north-west London, where the trial was conducted. Government inspectors started an urgent investigation into the trial, and are keeping the police informed about what they find. The drug is being developed for the German company TeGenero to treat chronic inflammatory conditions and leukaemia. The trial was set up by the US firm Parexel. Article continues -------------------------------------------------------------------------------- -------------------------------------------------------------------------------- The girlfriend of one of the men said his head had swollen beyond recognition. Myfanwy Marshall told BBC News 24: "He is already a big kind of guy, but his face is out here, like Elephant Man. It's completely puffed." Ryan Flanagan, a 21-year-old student, was taken to intensive care three hours after taking the tablets, the Sun reported. His family was told he could not breathe and his head and neck had swollen considerably. Family friend Sarah Brown, 27, told the newspaper: "Ryan was a healthy young man and he saw the trial advertised on the internet. He told us he would be paid £2,000 and did not think there would be any problems." Ganesh Suntharalingam, clinical director of intensive care at the hospital, said: "Two patients remain critical and four patients are serious but showing some signs of improvement. "The drug, which is untested and therefore unused by doctors, has caused an inflammatory response that affects some organs of the body. Representatives of all the families concerned had a meeting with Parexel and TeGenero. The government regulator that oversees drug tests has suspended the trial and is sending in investigators to find out what went wrong. The Medicines and Healthcare Products Regulatory Agency said eight men were taking part in the trial. Six were given the drug and two a placebo. Those who took the drug fell ill. Kent Woods, the agency's chief executive, said: "Our immediate priority has been to ensure that no further patients are harmed. "We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken." Parexel, the clinical research company running the trial, said it had operated within regulatory guidelines and that such adverse reactions to drugs were extremely rare. The Daily Mail reported that the drug was known as TGN1412 and was made by the pharmaceutical company TeGenero AG, based in Wurzburg, Germany. Richard Ley, spokesman for the Association of the British Pharmaceutical Industry, said: "This is an absolutely exceptional occurrence. I cannot remember anything comparable. "People taking part in clinical trials are carefully monitored at all stages of the trial. "Phase-one trials use healthy volunteers and are designed to test the safety of the drug. These go on to further tests with people who have the condition to determine whether the drug works." Scientists said they feared publicity of the bungled trial would make it difficult to attract members of the public to take part in future trials. Professor Richard Gray, director of the University of Birmingham clinical trials unit, said: "It is very, very rare indeed for something as catastrophic as this to happen." He added: "What alarms people like me, who organise clinical trials as part of my research activity, is that the next person might think that clinical trials are really dangerous whereas they just mimic normal clinical practice." Liberal Democrat MP Evan Harris, who took part in a safety study of a potential Aids vaccine in 2000, urged people to keep taking part in clinical trials. He said: "Such trials are a critical step in the generation of new treatments for human disease. Both patients and volunteers should be further reassured that there is tight regulation of clinical trials." "I would have no hesitation in volunteering for another clinical trial." Professor Herman Scholtz, from Parexel, insisted that the company had stuck to regulatory guidelines when conducting the trial.