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ADVENTRX To Present Complete ANX-530 Pharmacokinetic Data At The 2008 American Association For Cancer Research Annual Meeting
ADVENTRX Pharmaceuticals,
Inc. (Amex: ANX), announced that complete pharmacokinetic data from
the Company's marketing-enabling bioequivalence clinical study of ANX-530
(vinorelbine emulsion) has been accepted for presentation at the 2008
American Association for Cancer Research (AACR) Annual Meeting, which takes
place April 12 - 16, 2008 in San Diego, CA.
The poster presentation entitled "Pharmacokinetic equivalence observed
between an emulsion formulation of vinorelbine (ANX-530) and vinorelbine
solution in a clinical study of patients with advanced cancer," is
scheduled to be presented on April 13, 2008.
ADVENTRX recently completed a marketing-enabling bioequivalence
clinical study of ANX-530. The primary endpoint in the study was met, with
pharmacokinetic equivalence observed between ANX-530 and the reference drug
Navelbine(R). Furthermore, ANX-530 demonstrated a statistically significant
reduction in injection site reactions when compared to Navelbine.
Presentation of complete safety results including injection site reactions,
have been submitted for presentation at an upcoming oncology conference.
ADVENTRX intends to submit to the U.S. Food and Drug Administration (FDA) a
Section 505(b)(2) New Drug Application (NDA) for ANX-530 in the fourth
quarter of 2008.
About ANX-530 (vinorelbine emulsion)
ANX-530 is designed to reduce the incidence and severity of injection
site reactions from intravenous delivery of vinorelbine tartrate.
Vinorelbine tartrate works by disrupting microtubule formation and is a
member of the vinca alkaloid class of antineoplastic agents. Vinorelbine is
indicated as a single agent or in combination with cisplatin for treatment
of advanced non-small cell lung cancer and has also shown activity in
breast, ovarian, and other cancers.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical research and
development company focused on commercializing proprietary product
candidates for the treatment of cancer and infectious diseases. The Company
seeks to improve the performance and safety of existing treatments by
addressing significant problems, such as drug metabolism and
bioavailability, excessive toxicity and treatment resistance. More
information can be found on ADVENTRX's web site at http://www.adventrx.com.
Forward Looking Statement
ADVENTRX cautions you that statements included in this press release
that are not a description of historical facts are forward-looking
statements that involve risks and assumptions that, if they materialize or
do not prove to be accurate, could cause ADVENTRX's results to differ
materially from historical results or those expressed or implied by such
forward-looking statements. These risks and uncertainties include, but are
not limited to: the risk of investigator bias in reporting adverse events
as a result of the study's open-label nature, including bias that increased
the reporting of adverse events associated with Navelbine and/or that
decreased the reporting of adverse events associated with ANX-530; the risk
the FDA will determine that ANX-530 and Navelbine are not bioequivalent,
including as a result of performing pharmacokinetic equivalence analysis
based a patient population other than the population on which ADVENTRX
based its analysis; difficulties or delays in manufacturing, marketing and
obtaining regulatory approval for ANX-530, including validating commercial
manufacturers and suppliers and the potential for automatic injunctions
regarding FDA approval of ANX-530 and other challenges by patent holders
during the Section 505(b)(2) process; the risk that ADVENTRX will be unable
to raise sufficient capital to fund the projects necessary to meet its
goals, including funding the continued development and commercialization of
ANX-530; the potential for regulatory authorities to require additional
preclinical work or other clinical requirements to support regulatory
filings; patent and non-patent exclusivity covering Navelbine; ADVENTRX's
lack of long-term agreements with suppliers of ANX-530 components and
contract manufacturers of ANX-530, including its inability to timely secure
commercial quantities of ANX-530 or its components on commercially
reasonable terms, or at all; uncertainty under Section 505(b)(2) resulting
from legal action against the FDA and the potential that future
interpretations of Section 505(b)(2) could delay or prevent the FDA from
approving any Section 505(b)(2) NDA; and other risks and uncertainties more
fully described in ADVENTRX's press releases and periodic filings with the
Securities and Exchange Commission. ADVENTRX's public filings with the
Securities and Exchange Commission are available at http://www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date when made. ADVENTRX does not
intend to revise or update any forward-looking statement set forth in this
press release to reflect events or circumstances arising after the date on
which it was made.
ADVENTRX Pharmaceuticals, Inc.
http://www.adventrx.com
ADVENTRX de a prezenta complet ANX-530 date de farmacocineticã la 2008 de Asociatia Americana pentru cancer de cercetare reuniuni anuale - ADVENTRX To Present Complete ANX-530 Pharmacokinetic Data At The 2008 American Association For Cancer Research Annual Meeting - articole medicale engleza - startsanatate