Newsgroup: it.economia.borsa
Titolo: petizione CELL...

 saluti alleggeriti

 precisione ieri... ci risentiamo a settembre...
ok buone vacanze a tutto il POOL POMPISTI CELL   :-)))


Sei proprio convinto che, se continuano con la petizione, il titolo regga 
fino a settembre? 

 fino a settembre?
c'č addirittira chi si spinge a dire che Bianco lo voglia delistare da 
Milano avendo dichiarato che i problemi gli arrivano tutti dall'Italia, che 
faccua tosta..
senza a.d.c ha cassa proprio fino a settembre, ma l'ad.c. lo hanno deicos, 
quindi...
no so quanto possa fallire una bio che ha un fast track approvato... e un 
iterim alle porte su un secondo prodotto...
a meno che Novartis o qualcun altro se la voglia pappare a costo zero...
beh allora... 

 ok buone vacanze a tutto il POOL POMPISTI CELL   :-)))
ma quali vacanze!!! si e no una settimana a fine agosto....
... anche quest'anno estate a base di muratori, idraulici e pittori....
'tacci mia 

 fino a settembre?
Riepilogo sommario dello stato dei vari trial alla luce di:
- ricerche dei vari frequentatori di forum ecc...
- info IR
- comunicati vari
----------------------------- 
XYOTAX
1) Phase II Study of Combination of Paclitaxel Poliglumex and Alimta for 
Advanced NSCLC
http://www.clinicaltrials.gov/ct/show/NCT00487669?order=1
STATO: in fase di reclutamento
2) GOG 0212 - Paclitaxel or Polyglutamate Paclitaxel or Observation in 
Treating Patients With Stage III or Stage IV Ovarian Epithelial or 
Peritoneal Cancer (Phase III)
http://www.clinicaltrials.gov/ct/show/NCT00108745?order=2
STATO: in fase di reclutamento
INFO: probabile interim seconda metà 2008
3) Efficacy and Safety Study of Xyotax to Treat Prostate Cancer (Phase II)
http://www.clinicaltrials.gov/ct/show/NCT00446836?order=3
STATO: in fase di reclutamento
4) A Phase I Study of CT-2103 in Combination With Gemcitabine in Metastatic 
Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00270907?order=4
STATO: in fase di reclutamento
5) Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV 
Prostate Cancer (Phase II)
http://www.clinicaltrials.gov/ct/show/NCT00459810?order=5
STATO: in fase di reclutamento
6) Study of Xyotax (CT-2103) in Patients With Metastatic Breast Cancer 
(Phase II)
http://www.clinicaltrials.gov/ct/show/NCT00148707?order=1
STATO: Terminato
INFO: ATTENZIONE QUANTO SEGUE SI SUPPONE SOLO SIA RIFERITO ALLO STUDIO 
SOPRA: Summary This study evaluated the safety and efficacy of CT-2103, a 
novel conjugate of paclitaxel and poly-l-glutamate, in patients with 
HER2-negative, metastatic breast cancer who had received 0 or 1 prior lines 
of chemotherapy. Although CT-2103 had activity in this small study, 
neurotoxicity and
hypersensitivity reactions were more frequent in this patient population 
than expected, and led to early termination of the trial. Purpose To 
evaluate the safety and efficacy of CT-2103, a novel conjugate of paclitaxel 
and
poly-l-glutamate, in patients with metastatic breast cancer who had received 
0 or 1 prior lines of chemotherapy. Patients and Methods Eighteen women with
HER2-negative breast cancer were enrolled. Patients received intravenous 
CT-2103 at a dose of 175 mg/m2 of conjugated paclitaxel over 10 min every 3 
weeks, without routine premedication. Eighty-three percent of women had 
received prior
chemotherapy as part of adjuvant (39%), metastatic (17%), or both adjuvant 
and metastatic (28%) treatment. Three patients (17%) had previously received 
a taxane in the adjuvant setting. Results Objective responses were observed 
in 4 of 18 patients (overall response rate, 22%, 95% confidence interval, 6 
to 48%). Grade 3 or 4 neuropathy was observed in four patients. Grade 3 or 4 
hypersensitivity reactions (HSR) were observed in four patients; none 
occurred prior to cycle 4 of therapy. Because of the higher-than-expected 
rate of HSR, the study was terminated early. Conclusion Although CT-2103 had 
activity in this small study of women with HER2-negative metastatic breast 
cancer, neurotoxicity and hypersensitivity reactions were more frequent in 
this patient population than expected.
Hypersensitivity reactions were most likely to occur in later cycles of 
treatment, suggesting a true drug allergy, distinct from the HSR typically 
seen with standard paclitaxel.
7 ) Paclitaxel Poliglumex and Capecitabine in Treating Patients With 
Metastatic Breast Cancer (Phase II)
http://www.clinicaltrials.gov/ct/show/NCT00265733?order=4
STATO: chiuso l'arruolamento a metà aprile 2007
INFO: probabile interim fine 2007
8 ) Phase II CT-2103/Carboplatin in Ovarian Cancer
http://www.clinicaltrials.gov/ct/show/NCT00148707?order=1
STATO: chiuso
INFO: il report clinico è atteso per il trimestre in corso.
9) A Survival Study for Women With Advanced Lung Cancer Who Have Not 
Previously Received Chemotherapy (Phase III - PGT305 - Pioneer)
http://www.clinicaltrials.gov/ct/show/NCT00269828?order=16
STATO: Terminato
INFO: In December 2006, in agreement with the Data Safety Monitoring Board, 
we closed the PIONEER trial and took patients off both treatment arms. Our 
decision was due in part to the diminishing utility of the PIONEER trial 
given our plans to submit a new protocol to the U.S. Food and Drug 
Administration (FDA).
Clinical Trials for Women with Lung Cancer
As a follow-up to the PIONEER trial, we have submitted under Special 
Protocol Assessment (SPA) with the FDA protocols for two trials for women 
with normal estrogen levels, the subset where XYOTAX™ demonstrated the 
greatest survival advantage in the STELLAR trials.
In March 2007, we submitted a SPA for a phase III trial of combination 
therapy for women with advanced NSCLC. This trial, PGT307, will study 
first-line XYOTAX™ in combination with carboplatin versus 
paclitaxel/carboplatin in female patients with performance status of 0, 1, 
or 2.
In January 2007, we submitted a SPA for a phase III trial of single-agent 
XYOTAX™ for women with advanced NSCLC. This trial, PGT306, will focus on 
poor performance status (PS2) women who have not received prior 
chemotherapy.
10) A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and 
Carboplatin in Stage III Non-Small
http://www.clinicaltrials.gov/ct/show/NCT00352690?order=5
STATO: Sospeso
INFO: probabile sospensione per consentire follow-up prima della ripresa 
arruolamento
PIXANTRONE
1) Pixantrone or Other Chemotherapy Drugs in Treating Patients With Relapsed
Non-Hodgkin's Lymphoma (Phase III - Extend)
http://www.clinicaltrials.gov/ct/show/NCT00088530?order=1
STATO: in fase di reclutamento
INFO: probabile interim entro settembre 2007
2) A Trial in Patients With Diffuse Large-B-Cell Lymphoma Comparing 
Pixantrone Against Doxorubicin (Phase III - RAPID)
http://www.clinicaltrials.gov/ct/show/NCT00268853?order=3
STATO: in fase di reclutamento
INFO: probabile interim autunno 2007
3) A Phase I/II Study of Pixantrone (BBR 2778) in Patients With Refractory 
Acute Myelogenous Leukemia (AML)
http://www.clinicaltrials.gov/ct/show/NCT00106600?order=1
STATO: chiuso
INFO: stiamo preparando il relativo report di
analisi dei dati. Inoltre, dato che lo sperimentatore di questo trial ha
troppi studi simili in corso, prevediamo di fare un altro trial
"investigational" su AML a Chicago.
4) Pixantrone and rituximab (FP-R) compared to the combination of 
fludarabine and rituximab (F-R) (Phase III)
STATO: CTI is awaiting feedback from the FDA on the design of its PIX303
trial, which will examine the time to disease progression for the
combination regimen of fludarabine, pixantrone and rituximab (FP-R)
compared to the combination of fludarabine and rituximab (F-R) in the
treatment of patients who have failed up to five prior treatments for
relapsed or refractory NHL. The trial, submitted under the FDA's Special
Protocol Assessment procedure, is expected to enroll 300 patients beginning
in the second quarter with interim data by mid-2008
INFO: fast track
CT-2106
1) CT-2106 for the Second Line Treatment of Ovarian Cancer (Phase II)
http://www.clinicaltrials.gov/ct/show/NCT00291837?order=1
STATO: database chiuso
INFO: il report clinico è atteso per il quarto trimestre 2007
2) Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer
http://www.clinicaltrials.gov/ct/show/NCT00291785?order=2
STATO: chiuso
INFO: Prevediamo la chiusura del database (quindi con i dati definitivi) per 
il Q1 2008
Una precisazione: a causa della mancanza di finanziamenti, allo stato
attuale non sono previsti altri studi per CT-2106.
_______________________________________
Domande:
- perchè MOSTRUOSO ritardo EMEA?
- perchè Novartis ci mette tanto a decidere di spendere per il pgt306 quando 
invece butta miliardi su altre decine di trials?
- perchè la FDA ci mette tanto sui pgt? cosa è andato per le lunghe dato che 
JB diceva che entro il primo trimestre sarebbe partito l'arruolamento?