By Patricia Reaney
LONDON (Reuters) – Tragic results from a clinical study of
a new drug which has left six men in Britain seriously ill
could be a setback for other trials, at least in the
short-term, an industry expert said on Friday.
Two of the paid volunteers who were given the drug designed
to treat chronic inflammatory conditions and leukemia remained
in critical condition despite being given blood transfusions.
Four others being treated at Northwick Park Hospital in
northwest London where they were given the drug TGN 1412 early
this week were listed as serious but showing signs of
improvement.
Doctors and family members have pleaded for international
help from scientists to help save the lives of the men, who
suffered multiple organ failure.
Aisling Burnand, chief executive of the Bioindustry
Association in Britain, expressed her concern.
“It is shocking because of its severity,” she told Reuters.
Burnand said the industry will do everything it can to work
with regulators to implement whatever comes out of an inquiry
by the Medicines Healthcare products Regulatory Agency (MHRA),
which is looking at why the men suffered such a reaction.
Burnand anticipated the tragedy will deter volunteers from
taking part in drug trials.
“There may be initial reticence to actually get involved in
clinical trials,” she said. “I think it will have a short-term
impact, albeit hopefully small.”
British police are talking to the MHRA and German
prosecutors said on Friday they were considering whether to
start a formal investigation into the private German
biopharmaceutical company TeGenero AG that makes the drug.
EXTREMELY RARE EVENT
Serious side effects are extremely rare in so-called Phase
1 clinical studies that test the safety of experimental
compounds on healthy people.
Doctors treating the men in the trial run by U.S. drug
research company Parexel International Corp. on behalf of
TeGenero, said they do not known what went wrong.
Parexel said it had operated within regulatory guidelines.
A volunteer who was given a placebo, or dummy drug,
described how the other men were writhing in agony, vomiting
and screaming about the pain in their heads after taking the
drug.
TGN 1412 belongs to a class of drugs known as monoclonal
antibodies which target specific proteins on the surface of
cells.
Industry analysts said the tragedy had not impacted
biotechnology stocks in Europe, with investors so far viewing
it as a one-off event.
“It hasn’t had a knock-on impact as far as we can tell,”
said Mike Booth of stockbroker Canaccord Adams, adding that it
had highlighted the inherent risks involved in new medicines.
A total of 18 antibody products have been approved for sale
and their combined worldwide sales reached $14 billion last
year. They include a number of promising anti-cancer
treatments, such as Roche’s Herceptin, as well medicines to
fight rheumatoid arthritis.
(Additional reporting by Ben Hirschler in London)
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