Re: Phase I Trial Of Biologic Drug Being Tested For Rheumatoid Arthritis Halted Beca

[Guest guest]

Toni,

It sounds as if what these men in the TBN1412 trial suffered was the product

of a " cytokine storm. "

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

[ ] Phase I Trial Of Biologic Drug Being Tested For

Rheumatoid Arthritis Halted Beca

_http://arthritis.about.com/b/a/252365.htm_

(http://arthritis.about.com/b/a/252365.htm)

Phase I Trial Of Biologic Drug Being Tested For Rheumatoid Arthritis Halted

Because Unexpected Adverse Event Lands Volunteers In Intensive Care Unit

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March 15, 2006

_Phase I Trial Of Biologic Drug Being Tested For Rheumatoid Arthritis

Halted

Because Unexpected Adverse Event Lands Volunteers In Intensive Care Unit_

(http://arthritis.about.com/b/a/252365.htm)

In the first clinical trial on humans of TBN1412, a drug being developed to

treat inflammatory and autoimmune diseases such as _rheumatoid arthritis_

(http://arthritis.about.com/od/rheumatoidarthritis/) and leukemia, six

healthy

volunteers became ill within hours of taking the drug on Monday. Two of the

six men are critically ill, while the other four are in serious condition,

_according to BBC News_

(http://arthritis.about.com/gi/dynamic/offsite.htm?site=http://news.bbc.co.uk/2/\

hi/uk_news/england/london/4808836.stm)

Two other

volunteers who were given a placebo did not become ill. The six volunteers

who

became ill are in the intensive care unit of Northwick Park Hospital in

northwest London.

TBN1412 is manufactured by TeGenero AG and the trial was being conducted by

U.S. company Parexel. The cause of the disastrous result is being

investigated

while speculation has spiraled around possibilities including manufacturing

problems, contamination, dosing error, or an unknown side effect specific to

humans. TGN1412 is an immunomodulatory humanized agonistic anti-CD28

monoclonal antibody. The trial was a _Phase I clinical trial_

(http://arthritis.about.com/od/trials/a/clinicaltrials.htm) .

_Statement Regarding Clinical Volunteers and TGN 1412, from Te Genero_

(http://arthritis.about.com/gi/dynamic/offsite.htm?site=http://www.tegenero.com/\

news

/statement_re_tgn1412/index.php) _International Statement Regarding

Tegenero AG Phase I Trial , from Parexel_

(http://arthritis.about.com/gi/dynamic/offsite.htm?site=http://www.parexel.com/n\

ews_and_events/press_releasesSingle.asp?i

d=233) _UPDATE 3/16/06 from BBC News - What Actually Happened?_

(http://arthritis.about.com/gi/dynamic/offsite.htm?site=http://news.bbc.co.uk/2/\

hi/health/

4813478.stm) _UPDATE 3/17/06 from BBC News - Four Men Have Regained

Consciousness_

(http://arthritis.about.com/gi/dynamic/offsite.htm?site=http://news.bbc.co.uk/2/\

hi/uk_news/england/london/4815780.stm)