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Vion Pharmaceuticals Announces FDA Lift Of Clinical Hold On Phase III Study Of Cloretazine(R) (VNP40101M) And Cytarabine In Relapsed AML
VION
PHARMACEUTICALS, INC. (Nasdaq: VION) announced that the U.S. Food and
Drug Administration (FDA) had lifted the clinical hold on the Phase III
trial (Vion Study CLI-037) of its lead anti-cancer agent, Cloretazine(R)
(VNP40101M), in combination with cytarabine in relapsed acute myelogenous
leukemia (AML).
Alan Kessman, Chief Executive Officer, said, "We are pleased with the
FDA's decision to lift the clinical hold on Cloretazine(R) (VNP40101M) in
combination with cytarabine in relapsed AML, and are now poised to move
forward with the clinical development of Cloretazine(R) (VNP40101M) in the
relapsed setting."
While this trial remains blinded overall, a portion of data on 210
patients was unblinded for review at interim analysis. The Company's
medical consultants and external independent reviewers performed a
comprehensive safety analysis of Vion Study CLI-037. This analysis
concluded that the combined myelosuppressive effects of Cloretazine(R)
(VNP40101M) and cytarabine given at the dose and schedule at which they
were combined in the trial, in conjunction with the poor hematologic
reserve of patients with relapsed AML, were major factors in the difference
in mortality seen between the two arms of the study. A review of records
from patients who died did not suggest any previously unreported toxicity
for Cloretazine(R) or cytarabine.
There was an increase in the response rate observed on the
Cloretazine(R) (VNP40101M) and cytarabine arm of the trial relative to the
cytarabine and placebo arm, despite the difference in deaths between the
two arms. Given this observed increase in response rate, the Company has
proposed an amended trial to continue its interest in the relapsed setting.
An agreement has been reached with the FDA on modifications to Vion
Study CLI-037. The revised study includes a lower dose of Cloretazine(R)
(VNP40101M) in the experimental arm of the trial and prophylactic therapy
with antibiotics, antifungals and growth factors for all patients. In order
to maintain the Special Protocol Assessment (SPA) with the FDA for this
trial, the next step is to submit an SPA to the FDA with these
modifications before recommencing the trial.
Dr. Frank Giles, Chief of the Division of Hematology and Medical
Oncology at the University of Texas Health Science Center at San Antonio,
and lead investigator on the Cloretazine(R) clinical program stated,
"Cloretazine(R) has recently shown very significant single agent activity
in a the difficult to treat elderly AML patient population. It is important
that we now establish the optimal dosing schedule in combination with other
chemotherapeutic agents, such as cytarabine." He concluded, "Modifications
to this Phase III trial in patients with relapsed AML will allow us to
examine a combination schedule that should maintain the activity observed
in the initial portion of the study with an acceptable marrow toxicity
profile."
The Company also announced plans to file an abstract on data from Vion
Study CLI-037 for the Annual Meeting of the American Society of Clinical
Oncology (ASCO(R)) in June 2008.
Ann Cahill, Vice President, Clinical Development, commented,
"Cloretazine(R) (VNP40101M) is an active agent in AML, and we continue to
believe that it will have clinical utility in both the frontline and second
line settings, as either a single agent or in combination with other
therapies."
The Company has announced previously that it plans to file a New Drug
Application with the FDA in 2008 based on a pivotal Phase II study of
Cloretazine(R) (VNP40101M) as a single agent in elderly patients with de
novo poor-risk AML. Preliminary data from this study were presented at the
2007 Annual Meeting of the American Society of Hematology (ASH(R)) in
December 2007.
Vion Pharmaceuticals, Inc. is committed to extending the lives and
improving the quality of life of cancer patients worldwide by developing
and commercializing innovative cancer therapeutics. Vion has two agents in
clinical trials. Cloretazine(R) (VNP40101M), a unique alkylating agent, is
being evaluated in a Phase II pivotal trial as a single agent in elderly
patients with previously untreated de novo poor-risk acute myelogenous
leukemia. Clinical trials of Cloretazine(R) (VNP40101M) as a single agent
in small cell lung cancer, with temozolomide in brain tumors, and with stem
cell transplantation in advanced hematologic malignancies, are also being
conducted. Triapine(R), a potent inhibitor of a key step in DNA synthesis,
is being evaluated in clinical trials sponsored by the National Cancer
Institute. For additional information on Vion and its product development
programs, visit the Company's Internet web site at http://www.vionpharm.com.
This news release contains forward-looking statements. Such statements
are subject to certain risk factors which may cause Vion's plans to differ
or results to vary from those expected, including Vion's potential
inability to obtain regulatory approval for its products, delayed or
unfavorable results of drug trials, the possibility that favorable results
of earlier preclinical studies or clinical trials are not predictive of
safety and efficacy results in later clinical trials, the need for
additional research and testing, the potential inability to secure external
sources of funding to continue operations, the inability to access capital
and funding on favorable terms, continued operating losses and the
inability to continue operations as a result, and a variety of other risks
set forth from time to time in Vion's filings with the Securities and
Exchange Commission, including but not limited to the risks attendant to
the forward-looking statements included under Item 1A, "Risk Factors" in
Vion's Form 10-K for the year ended December 31, 2006 and the Company's
Form 10-Q for the quarter ended September 30, 2007. In particular, there
can be no assurance as to the results of any of the Company's clinical
trials, that any of these trials will continue to full accrual, or that any
of these trials will not be discontinued, modified, delayed or ceased
altogether. Except in special circumstances in which a duty to update
arises under law when prior disclosure becomes materially misleading in
light of subsequent events, Vion does not intend to update any of these
forward-looking statements to reflect events or circumstances after the
date hereof or to reflect the occurrence of unanticipated events.
Vion Pharmaceuticals, Inc.
http://www.vionpharm.com
Vion Pharmaceuticals Announces FDA Ridicaþi Hold On clinice de fazã III de studiu Din Cloretazine (R) (VNP40101M) ªi Cytarabine În Relapsed AML - Vion Pharmaceuticals Announces FDA Lift Of Clinical Hold On Phase III Study Of Cloretazine(R) (VNP40101M) And Cytarabine In Relapsed AML - articole medicale engleza - startsanatate