Cell Therapeutics ha deciso di chiudere lo studio clinico PGT305 PIONEER
sul cancro al polmone e di sospendere il trattamento di entrambi i
gruppi di pazienti. La scelta - riporta la nota - si deve in parte
all'utilita della sperimentazione in corso, data che la CTI ha in
programma di presentare all'FDA, l'ente statunitense per il controllo su
alimentari e farmaci, un nuovo protocollo, oltre che al numero
anormalmente basso di decessi nel gruppo di controllo. La CTI ha in
previsione di proporre all'FDA entro la fine dell'anno, tramite Special
Protocol Assessment, una revisione del protocollo definito PGT306.

Cell Therapeutics Closing Trial

By Althea Chang
TheStreet.com Staff Reporter
12/8/2006 11:02 AM EST


Cell Therapeutics' (CTIC - commentary - Cramer's Take - Rating) shares
rose Friday after the company announced plans to close a trial on its
drug Xyotax in the treatment of lung cancer.


Shares gained 2.8% to $1.87.
The decision was due, in part, to the company's plans to submit a new
study design to the Food and Drug Administration in light of the
aberrantly low rate of deaths in a certain group of patients during the
study, dubbed PGT305.

The company now plans to focus exclusively on women with normal
estrogen levels, a subgroup of patients that have already demonstrated
the greatest survival advantage when treated with the drug in previous
trials.

"While the patients in the Pioneer PGT305 study will not count toward
our final pivotal trial results, the data from this trial will be
instrumental in helping us understand the unique properties of this
biologically enhanced chemotherapeutic and its potential as a
gender-specific therapy for women with lung cancer and other tumors
where estrogen can influence the uptake and metabolism of Xyotax," said
CEO Dr. James Bianco.