Newsgroup: it.economia.borsa
Titolo: cell

14.04.09 09:49 - Cell T.: avviata application presso FDA per pixantrone
BRESSO (MF-DJ)--Cell T. ha avviato una richiesta per l'autorizzazione al 
commercio di un nuovo farmaco presentata in piu' fasi ("rolling" New Drug 
Application o NDA) presso l'ente statunitens Food and Drug Administration 
(FDA), relativa a pixantrone impiegato per il trattamento del linfoma 
non-Hodgkin (NHL) aggressivo recidivato o refrattario.
Cell T., si legge in una nota, prevede di completare la presentazione della 
richiesta entro il trimestre corrente e richiedera' una valutazione 
prioritaria, che, se concessa, dovrebbe condurre alla decisione in merito 
all'approvazione entro il quarto trimestre di quest'anno.
"La commercializzazione di pixantrone accrescera' il valore per gli 
azionisti, visto il vasto mercato potenziale per questo prodotto" ha 
dichiarato James A. Bianco, CEO di Cell Therapeutics. com/kam
(END) Dow Jones Newswires
April 14, 2009 03:49 ET (07:49 GMT)
© 2009 MF-Dow Jones News Srl. 

SEATTLE, April 14 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) 
(Nasdaq and MTA: CTIC) announced today that it began a rolling submission of 
a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) 
for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's 
lymphoma (NHL). CTI expects to complete the submission this quarter and will 
request priority review which if granted could lead to an approval decision 
from the FDA in Q4 2009.
"This is a significant milestone for CTI as we move pixantrone closer to 
addressing a truly significant unmet medical need for relapsed or refractory 
aggressive NHL patients," said James A. Bianco, M.D., CEO of CTI. "The 
commercialization of pixantrone will drive shareholder value as a result of 
the large market potential for this product. We believe that the recent 
significant investment in CTI by a single institutional investor reflects a 
growing interest in CTI and in particular in pixantrone by the investment 
community. With added financial resources, CTI can advance pixantrone 
through the NDA review process while we continue our progress on strategic 
business development opportunities and relationships."
CTI previously announced that its pivotal phase III (PIX 301) EXTEND trial 
had achieved its primary endpoint with patients randomized to treatment with 
pixantrone achieving a significantly higher rate of confirmed (CR) and 
unconfirmed complete remissions (CRu) compared to patients treated with 
standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 
(5.7%) for the standard chemotherapy arm, p = 0.02) with no patients in the 
standard chemotherapy arm achieving a confirmed complete remission. 
Additionally, progression-free survival (PFS) results from this study show 
patients treated with pixantrone experienced a statistically significant 
improvement in median progression-free survival, compared with other 
single-agent chemotherapeutic agents (4.7 months vs. 2.6 months, p < 0.01, 
pixantrone vs. standard chemotherapy) based on an intent to treat analysis. 
Pixantrone treatment also significantly increased the overall response rate 
(CR/CRu+PR) (26/70 (37.1%) for pixantrone arm compared to 10/70 (14.3%) for 
the control arm, p = 0.003).
Pixantrone recipients had a low incidence of severe neutropenia complicated 
by either fever or documented infections, or severe vomiting or diarrhea. 
Pixantrone patients also experienced a low incidence of hair loss, a very 
common side effect of other drugs in this class. Overall, the incidence of 
serious adverse events was similar between pixantrone and the control arm. 
The pixantrone patients had a higher incidence of leucopenia and neutropenia 
and numerically more severe cardiac events (5 vs. 2) with only 1 considered 
related to the study drug by the investigator. Disease progression reported 
as an adverse event was less frequent in the pixantrone than in the control 
arm (1.5% vs. 13.4%).
The pixantrone study received Special Protocol Assessment approval from the 
FDA in 2004, and pixantrone has received fast track designation for this 
indication. The FDA's fast track programs are intended to expedite the 
review of drugs that treat serious or life-threatening conditions and 
demonstrate the potential to address unmet medical needs. The rolling 
submission process enables companies that have been granted fast track 
designation to submit sections of the NDA to the FDA as they become 
available, allowing the review process to begin before the complete dossier 
has been submitted.
About Pixantrone
Pixantrone (BBR 2778), is a novel major groove binder with an 
aza-anthracenedione molecular structure that differentiates it from the 
anthracyclines and other related chemotherapy agents. Anthracyclines are the 
cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast 
cancer. Although they are sufficiently effective to be used as first-line 
(initial) treatment, they cause cumulative heart damage that may result in 
congestive heart failure many years later. As a result, there is a lifetime 
limit of anthracycline doses and most patients who previously have been 
treated with an anthracycline are not able to receive further anthracycline 
treatment if their disease returns. Pixantrone has been designed to reduce 
the potential for these severe cardiotoxicities without sacrificing 
anti-cancer activity. It also can be administered through a peripheral vein 
rather than a central implanted catheter as required for other drugs in this 
class. 

Cell Therapeutics, Inc. annuncia la sottoscrizione di azioni privilegiate
per USD 15 milioni da parte di un singolo investitore istituzionale
"Ciascuna azione privilegiata di Serie 1 è convertibile, in qualsiasi
momento durante il corso della sua esistenza, in 3.333,33 azioni ordinarie
ad un prezzo di conversione di USD 0,30, per un impatto complessivo di circa
50.000.000 azioni ordinarie."
ecc
solita solfa

"mascheroni®" <matrix@reload> ha scritto nel messaggio 
news:49e4467e$0$1129$4faf...@reader1.news.tin.it...

Cell Therapeutics, avviata richiesta per commercializzare nuovo farmaco
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Cell Therapeutics ha annunciato oggi di aver avviato la richiesta presso 
l'ente statunitense Food and Drug Administration per l'autorizzazione al 
commercio di un nuovo farmaco. Si tratta del pixantrone, impiegato contro il 
linfoma non-Hodgkin aggressivo recidivato o refrattario. Il gruppo 
biofarmaceutico prevede di completare la richiesta entro questo trimestre e 
di ottenere il responso entro il quarto trimestre.
Sembrerebbe la solita solfa....ma le cose sono mooolto cambiate invece..... 

 solita solfa
cioč?? 

 cioč??
fanno uscire la notizia sulla domanda di registrazione del pix (tra l'altro
a step,quindi vendereanno piů volte la stessa notizia)
intanto convertono le priv in ordnarie(altra carta sul mercato )
a 0,30 dollari ad azione (calcolatevi il prezzo in euro)
ricordiamoci che se tutto andrŕ bene l'approvazione del pix č per fine anno

 anno
a NY è scesa molto ieri (essendo la borsa Usa aperta il lunedi dopo Pasqua) 
e forse da noi oggi è scesa slo per seguire quel calo usa di ieri;
invece stasera a NY è risalita abbastanza (+13%)
io la tengo monitorata, secondo me l'era delle grandi discese è finita e 
forse sta riaccumulando in vista di una possibile esplosione al rialzo che 
potrebbe avvenire anche mesi prima dell'approvazione del pix