ANALIZE MEDICALE DE LABORATOR
Aici gasiti analizele medicale grupate pe categorii precum si detalii generale si specifice pentru categoriile respective.
Selectati o categorie din lista de mai jos:
Solutie antistress!
Construieste poduri :)
Prinde pisica neagra :)
'Impressive' Complete Remission And 'Survival Data In Relapsed Indolent NHL Patients Identifies New Potential Registration Trial For Pixantrone
Cell Therapeutics,
Inc. (CTI) (Nasdaq: CTIC; MTAX) today announced results from a phase I/II
study of patients with relapsed indolent non-Hodgkin's lymphoma (NHL) that
may identify a potential registration trial for pixantrone. Among the 27
patients evaluable for response, study results showed the FPD-R regimen
with pixantrone produced an 89 percent overall response rate (ORR),
including 63 percent of patients experiencing a complete disappearance of
their disease (complete response, CR). The results were presented at the
48th Annual Meeting of the American Society of Hematology (ASH). The
estimated median duration of response was 25 months and the estimated
progression-free survival rate at three years was 50.4 percent. CTI plans
to request a meeting with the United States Food and Drug Administration
(FDA) to discuss a Special Protocol Assessment for a phase III trial
utilizing this regimen in indolent NHL.
"The use of pixantrone in the FPD-R combination produced impressive,
durable responses," said Luis Fayad, M.D., Associate Professor of Medicine,
Clinical Medical Director, Department of Lymphoma/Myeloma, The University
of Texas M. D. Anderson Cancer Center and principal investigator on the
study. "Given the results observed in this study, more studies with this
regimen are warranted."
Pixantrone in Combination with Fludarabine, Dexamethasone and Rituximab
(FPD-R) in the Treatment of Patients with Relapsed/Refractory Indolent NHL.
In a poster session, Dr. Fayad presented results from a phase I/II
study of pixantrone combined with fludarabine, dexamethasone, and rituximab
for treatment of patients with relapsed indolent NHL.
Of the 27 patients evaluable for response, 89 percent (24 patients)
achieved an objective response, including 70 percent (19 patients) who
achieved complete response/unconfirmed complete response (CR/uCR) and 19
percent (5 patients) achieving a partial response (PR). The estimated
median duration of response was 25 months (range 2.4 to 43 months) and the
estimated progression-free survival rate at three years was 50.4 percent.
No serious cardiotoxicity was observed. The primary toxicities (grade 3/4)
were hematologic including lymphopenia (89 percent), neutropenia (82
percent), leukopenia (79 percent), thrombocytopenia (21 percent) and
febrile neutropenia (11 percent). Preliminary results of this study were
announced in May 2006.
About the FPD-R Study
This trial examined the safety and potential efficacy for pixantrone
when substituted for mitoxantrone in the FND-R regimen (fludarabine,
mitoxantrone, dexamethasone, rituximab) for patients who had failed prior
treatment.
Patients received a median of five cycles (range 1 to 8) of therapy.
Cycles were every 28 days. Dosing was rituximab at 375 mg/m2 on day l,
fludarabine at 25 mg/m2 on days 2 through 4, dexamethasone at 20 mg per day
on days 1 through 5 and pixantrone starting at 80 mg/m2 (first three
patients) to 120 mg/m2 on day 2.
About the FND-R Regimen
The FND-R chemotherapy regimen (a combination of fludarabine,
mitoxantrone, dexamethasone, rituximab) is one of a number of regimens that
include fludarabine available to patients who relapse with low-grade NHL.
It has a notably high overall and complete response rate and is reasonably
well tolerated. Despite its impressive anti-tumor activity, FND-R often
cannot be used to re-treat patients who relapse due to the cumulative
cardiotoxicity associated with mitoxantrone. Pixantrone is a member of the
same class of compounds as mitoxantrone but in animal studies demonstrates
less cardiotoxcity when given to animals that received prior anthracycline
therapy. The current study demonstrates that substituting pixantrone for
mitoxantrone, yields a highly active therapeutic regimen with acceptable
levels of cardiotoxicity even in patients who have received prior
anthracycline therapy at close to lifetime limiting doses.
About Pixantrone
Pixantrone is an investigational agent under development for the
potential treatment of various hematological malignancies, solid tumors and
immunological disorders. It was developed to improve the activity and
safety of the anthracycline family of anti-cancer agents. Anthracyclines
have been shown to be very active clinically in a number of tumor types.
However, they are usually associated with cumulative heart damage that
prevents them from being used in a large proportion of patients. Pixantrone
has been designed to reduce the potential for these severe
cardiotoxicities, as well as to potentially increase activity and
simplified administration compared to the currently marketed
anthracyclines.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed
to developing an integrated portfolio of oncology products aimed at making
cancer more treatable. For additional information, please visit
http://www.cticseattle.com.
This press release includes forward-looking statements that involve a
number of risks and uncertainties, the outcome of which could materially
and/or adversely affect actual future results. Specifically, the risks and
uncertainties that could affect the development of pixantrone include risks
associated with preclinical and clinical developments in the
biopharmaceutical industry in general and with pixantrone in particular
including, without limitation, the potential failure of pixantrone to prove
safe and effective for treatment of non-Hodgkin's lymphoma, determinations
by regulatory, patent and administrative governmental authorities,
competitive factors, technological developments, costs of developing,
producing and selling pixantrone, and the risk factors listed or described
from time to time in the Company's filings with the Securities and Exchange
Commission including, without limitation, the Company's most recent filings
on Forms 10-K, 8-K, and 10-Q. Except as may be required by Italian law, CTI
is under no obligation to (and expressly disclaims any such obligation to)
update or alter its forward- looking statements whether as a result of new
information, future events, or otherwise.
Cell Therapeutics, Inc.
http://www.cticseattle.com
"Impresionant" remiterea completã ºi "date de supravieþuire la pacienþii cu recidivã nedureros NHL identificã potenþialele nou proces de înregistrare pentru Pixantrone - 'Impressive' Complete Remission And 'Survival Data In Relapsed Indolent NHL Patients Identifies New Potential Registration Trial For Pixantrone - articole medicale engleza - startsanatate