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

To: nigel bates who wrote (19314)	3/16/2006 9:26:09 AM
From: Biomaven	Respond to of 52153

So as Rick indicated, that timing makes the pathway I suggested yesterday pretty unlikely. Peter

To: nigel bates who wrote (19314)	3/16/2006 9:51:07 AM
From: John Metcalf	Read Replies (1) \| Respond to of 52153

This account from ITV says the reaction, for at least one patient, occured 80 to 90 minutes after drug administration. If it had been just a few seconds, they would probably have stopped dosing. Some doctors are finding fault with dosing all the subjects at the same time. Drug trial men remain seriously ill 11.22AM, Thu Mar 16 2006 Six men remain seriously ill in hospital after a clinical drugs trial went disastrously wrong. Two of the men are critically ill and the other four are still in a "serious" condition in the intensive-care unit of Northwick Park. The drugs company involved has apologised but the families of the men are bitter and angry. They claim their inquiries into exactly what went wrong at the Northwick Park Hospital in London have not been answered satisfactorily. Ann Alexander, who is representing a 29-year-old man on a life-support machine after taking the drug, said his prognosis was unclear at this stage. She said: "The family are very distraught and very scared because they do not know what the future is going to hold. "They have had two meetings with the drug company and questions have been asked which in their view have not been satisfactorily answered. "The doctors are treating the symptoms but because they do not know what has gone wrong it is difficult." Ms Alexander added that she believed that the drugs firm had pledged to give the young man's family all the financial support they required. Myfanwy Marshall, 35, said her boyfriend, one of the six patients, fell ill 80 or 90 minutes after being given an oral or injected dose on Monday. She said: "He is like a shell of who he is and this machine is pumping out his lungs. "His chest is puffed out. He is already a big kind of guy but his face is out here, like Elephant Man, it's completely puffed." The drug, known as TGN1412, is made by pharmaceutical company TeGenero AG, based in Wurzburg, Germany. It is intended to fight leukaemia, rheumatoid arthritis and multiple sclerosis. One of two trial volunteers who escaped unscathed after being given a placebo has described the horror as the drugs began to have their devastating effect on the other six men, who "went down like dominoes". Raste Khan, 23, said: "First they began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were going to explode. "It was terrifying because I kept expecting it to happen to me at any moment. But I felt fine and I didn't know why." Senior doctors are understood to be concerned that all six victims had been given the experimental drug at the same time - which it said went against guidance in The Textbook of Pharmaceutical Medicine which says such practices can be "very difficult to manage" and "put subjects at unnecessary risk." Scotland Yard confirmed it was talking to the UK medicines watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), about the incident. A police spokesman said: "We are liaising with the MHRA to establish the circumstances around the clinical trial of the drug." Chief scientific officer of TeGenero AG, Thomas Hanke, said he was "devastated" at the "shocking developments" in the testing of a new medicine which had showed no safety problems in previous trials. Initial research into the new medicine started in 1997 and it has been in development since 2000, but testing has now been halted.