Newsgroup: it.economia.borsa
Titolo: Cell Therapeutics, Inc. (CTI) Files for Special Protocol Assessment (SPA) With FDA for XYOTAX Lung Cancer Trial in Women

      Cell Therapeutics, Inc. (CTI) Files for Special Protocol Assessment
(SPA) With FDA for XYOTAX Lung Cancer Trial in Women
       CEO Reviews 2006 Accomplishments and Milestone Targets for
2007SEATTLE, Jan. 10 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI)
(Nasdaq: CTIC; MTAX) today announced it has filed for a Special Protocol
Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for the
design of its phase III trial of XYOTAX for women with advanced lung cancer.
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 follow-on study to the PIONEER
trial.
      "Through our clinical studies in 2006, we have gained important
insights into the best lung cancer patient population to target our XYOTAX
pivotal trial effort in order to minimize end-of-trial surprises while
maximizing the probability of success. We look forward to feedback and
guidance from the FDA on our phase III trial," said James A. Bianco, M.D.,
President and CEO of CTI. "Lung cancer continues to be the number one cancer
killer of women. Better treatments are needed to combat this disease that
will kill more than 70,000 women this year."
      In addition, Bianco reviewed CTI accomplishments for 2006 and
identified important Company milestones for 2007:
    -- "In 2006 the Company made significant progress in positioning XYOTAX,
       if approved, for successful commercialization," said Bianco. "A major
       development was the establishment of a potential $285 million
       commercial and development partnership for XYOTAX with Novartis,
       providing the global expertise and resources of one of the leading
       multi-national oncology companies."
    -- In addition the Company received positive advice and agreement from
the
       EMEA's Scientific Advice Working Party (SAWP) to switch from the
       superiority endpoint in the STELLAR 4 trial to a non-inferiority
       endpoint for XYOTAX. CTI plans to file a marketing authorization
       application (MAA) in Europe in 2007 for XYOTAX as a single agent for
       first-line treatment of non-small cell lung cancer (NSCLC) in men and
       women PS2 patients. "Given the recent article in the Journal of the
       National Cancer Institute showing the economic toll of the hours lost
       to cancer care, we believe the SAWP agreement recognizes this
important
       and often overlooked reality," said Bianco.
"For our other phase III product, pixantrone, we recently presented positive
clinical data at the American Society of Hematology (ASH) meeting showing
high overall responses from two pixantrone studies. In addition, based on
interim data from the first 40 patients on the EXTEND trial, a randomized
phase III study of pixantrone for patients with aggressive non-Hodgkin's
lymphoma (NHL), the Data Monitoring Committee recommended the study
continue," Bianco added.
      "2006 was a rebuilding year for the Company, establishing an important
partnership while advancing our two lead drug candidates toward market. With
two key regulatory events for XYOTAX and pixantrone, 2007 promises to be a
pivotal transition for the Company and its products."
    Key Target Milestones for 2007
    -- Reach Special Protocol Assessment agreement with FDA on PGT306
pivotal
       trial for XYOTAX in women with lung cancer and initiate enrollment at
       approximately 200 centers worldwide
    -- Reach Special Protocol Assessment agreement with FDA on PIX303
pivotal
       trial for pixantrone in first-line and second-line indolent NHL and
       initiate enrollment at more than 100 centers worldwide
    -- File a marketing authorization application (MAA) in Europe in 2007
for
       XYOTAX as a single agent for first-line treatment of non-small cell
       lung cancer (NSCLC) in PS2 patients
    -- Conduct interim analysis on phase III pixantrone clinical trial in
       relapsed aggressive NHL (EXTEND trial) and if compelling, meet with
FDA
       to discuss potential registration strategy
    -- Maintain burn rate at 2006 level, continue to strengthen and
       de-leverage balance sheet

 ha scritto nel messaggio 
news:45a4d74a$0$22399$4faf...@reader2.news.tin.it...


10.01.07 13:38 - Cell T.: richiede a Fda Special protocol assessment per 
Xyotax
MILANO (MF-DJ)--Cell Therapeutics ha annunciato di aver richiesto alla Fda 
uno "Special protocol assessment" per il design dello studio clinico di fase 
III di Xyotax su donne con cancro al polmone in fase avanzata.
Lo studio, denominato PGT306, sara' focalizzato esclusivamente su donne con 
normali livelli di estrogeni, cioe' il sottogruppo di pazienti in cui Xyotax 
ha dimostrato il miglior risultato in termini di sopravvivenza nei 
precedenti studi Stellar.
"Grazie agli studi clinici effettuati nel 2006", ha commentato in una nota 
James A.Bianco, presidente e a.d. di Cell T., "abbiamo acquisito conoscenze 
importanti riguardo alla popolazione piu' idonea delle pazienti affette da 
cancro al polmone per focalizzare il nostro sforzo di ricerca tramite lo 
studio clinico di Xyotax, con l'obiettivo di minimizzare gli insuccessi e al 
contempo massimizzarne le probabilita' di successo. Attendiamo ora il 
riscontro e i suggerimenti della Fda sul nostro studio di fase III". Com/pl


Impara a Quotare  meglio! 

 famo 'na scalpatina veloce come in autunno??
dentro a 1,38 x una scalpatina veloce

http://i16.tinypic.com/4e1ca6q.jpg
Mascherooooooooooooooooooooooooo
Mascherooooooooooooooooooooooooo
triplice incrocio dell'australiano 

 triplice incrocio dell'australiano 
detto così sembra tosto...
non sarà un fuoco di paglia?
-- 

 ha scritto nel messaggio 
news:200701101...@mynewsgate.net...

te puoi vede'  le medie mobbbbili dal 2003  mica se paga :-))) 

 non sarà un fuoco di paglia?
appena escono news  c'è sempre volatilità ,
ma se vai a vedere il grafico di medio-lungo, gli indicatori sono tutti in 
ipervenduto e pronti a far rimablzare anche di poco il titolo, e in un 
contesto simile, anche una news qualsiasi fa salire il titolo per un paio di 
giorni....

www.ilnuovomercato.it
Riduzione del debito, mantenendo il livello dei costi del 2006. E' questo 
l'obiettivo numero uno che si è posta Cell Therapeutics nel 2007 per quanto 
riguarda i conti della società. Dopo un 2006 di ricostruzione per la 
società, spiega il presidente ed ad James A. Bianco, grazie ad un'importante 
partnership