Newsgroup: it.economia.borsa
Titolo: CELL NEWS

      Cell Therapeutics, Inc. (CTI) Announces XYOTAX(TM) Has Fast Track
Designation for Women With Advanced Lung Cancer Who Are Performance Status 2
(PS2)
    PGT306 Trial Will Focus on Female PS2 Lung Cancer Patients With Normal
                               Estrogen LevelsSEATTLE, April 11
/PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX)
announced today that XYOTAX, a novel biologically- enhanced version of one
of the most used cancer drugs, Taxol(R), qualifies for fast track
designation for the treatment of PS2 (poor performance status) women with
first-line advanced non-small cell lung cancer (NSCLC). The Company recently
filed a Special Protocol Assessment (SPA) with the United States Food and
Drug Administration (FDA) for the design of its phase III trial of XYOTAX
for women with advanced NSCLC. The trial, PGT306, will focus exclusively on
women with normal estrogen levels, the subset where XYOTAX demonstrated the
greatest survival advantage in the STELLAR trials. The trial is expected to
enroll 300 poor performance status (PS2) women who have advanced stage non-
small cell lung cancer (NSCLC) and have not received prior chemotherapy.
Only women with normal estrogen levels either as a result of pre-menopausal
age or hormone replacement therapy will be randomized in the trial.
      Fast track designation was initially granted on June 11, 2003 for
XYOTAX for NSCLC PS2 patients (male and female). Confirmation from the FDA
was obtained on January 24, 2006 that the existing fast track designation
encompasses the treatment of female patients with advanced NSCLC with PS2.
Fast track designation was granted because NSCLC in PS2 patients is
incurable with available therapy offering only modest benefit, and XYOTAX
has the potential to demonstrate improvement over available therapy in these
patients.
      "We also submitted a SPA to the FDA for PGT307, a phase III trial of
combination therapy for women with advanced lung cancer. The trial will
study XYOTAX in combination with carboplatin versus paclitaxel/carboplatin
in female NSCLC patients with performance status of 0, 1 or 2," said James
A. Bianco, M.D., President and CEO of CTI. "Pending FDA feedback, we
anticipate that one or both of these trials would begin enrollment in the
second quarter of 2007 with a targeted interim analysis in the first half of
2008."
      Fast Track Designation
      Fast track designation means the FDA will facilitate and expedite the
development and review of the application for the approval of a new drug if
it is intended for the treatment of a serious or life-threatening condition
and demonstrates the potential to address an unmet medical need. An
expedited review as defined by the FDA user fee performance goals provides
for a review within six months.

appena arrivato dal ponte di pasqua neanche fatto intempo a collegarmi che
boooooooooom mi vedo la mega news ahahahah tutto scritto mio caro maschero'
prenota pure il ristornate stavolta non se
fermaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa!!

 ha scritto nel messaggio 
news:Uw4Th.28015$tx6....@tornado.fastwebnet.it...

Purtroppo per voi, in un altro forum, è entrato un contrarian su Cell, 
dicendo quello che stai dicendo tu.
Grattatevi.
Saluti mauro342
apuo