ADVENTRX Announces Completion of Patient Enrollment in ANX-530 Marketing-Enabling Clinical Study
October 10 2007 - 6:00AM
PR Newswire (US)
SAN DIEGO, Oct. 10 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (AMEX:ANX), a biopharmaceutical research and
development company focused on commercializing proprietary product
candidates for the treatment of cancer and infectious diseases,
announced today that it has completed patient enrollment in its
marketing-enabling clinical study of ANX-530 (vinorelbine
emulsion), a novel, emulsion formulation of vinorelbine tartrate.
Vinorelbine tartrate, marketed under the brand name Navelbine(R),
is an anti-cancer agent that is approved to treat advanced
non-small cell lung cancer as a single agent or in combination with
cisplatin. Worldwide annual sales of Navelbine and generic
vinorelbine in 2006 were approximately $200 million. "Completing
enrollment keeps us on schedule to announce results from this study
next month and, if the results are succesful, to submit an NDA as
early as next year," said Evan M. Levine, chief executive officer
of ADVENTRX. "Advancing ANX-530 is a key value-driver for this
company and we are taking the steps to help ensure its success. We
are preparing for a meeting with the FDA later this year and plan
to provide an update regarding our NDA timeline for ANX-530
following that meeting." ANX-530 is currently being tested in a
28-patient bioequivalence study. The study is a crossover
comparison of ANX-530 and Navelbine, also available as generic
vinorelbine, with a primary endpoint of pharmacokinetic equivalence
of ANX-530 and Navelbine. The safety of a single dose of ANX-530 is
being evaluated as a secondary endpoint. The FDA has indicated that
this single clinical study, should it demonstrate bioequivalence
between ANX-530 and Navelbine, would provide sufficient clinical
data to support the submission of an NDA. About ANX-530
(vinorelbine emulsion) ANX-530 is a novel emulsion formulation of
vinorelbine tartrate, a generic chemotherapy agent. ANX-530 is
designed to reduce the incidence and severity of vein irritation
from IV-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 Section
505(b)(2) Section 505(b)(2) of the U.S. Food, Drug & Cosmetic
Act (FDCA) allows the Food and Drug Administration (FDA) to approve
a follow-on drug on the basis of data in the scientific literature
or conclusions regarding safety or effectiveness made by the FDA in
the approval of other drugs. This regulatory pathway potentially
makes it easier for drug manufacturers to obtain rapid approval of
new forms of drugs based on the FDA's approval of the original
drug. Some examples of products that may be allowed to follow a
505(b)(2) path to approval are drugs that have a new dosage form,
strength, route of administration, formulation or indication. Upon
approval, a drug may be marketed only for the FDA-approved
indications in the approved dosage forms. Further clinical trials
are necessary to gain approval for the use of the product for any
additional indications or dosage forms. To the extent a Section
505(b)(2) applicant is relying on the FDA's findings for an
already-approved drug, the applicant is required to certify to the
FDA concerning any patents listed for the approved drug in the
FDA's Orange Book publication, which may include a certification
that listed patents are invalid or will not be infringed by the
manufacture, use or sale of the new drug. 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, bioavailability, excessive
toxicity and treatment resistance. More information can be found on
the Company'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, uncertainties,
assumptions and other factors that, if they do not materialize or
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 that results from
ADVENTRX's on-going marketing-enabling study will not indicate
bioequivalence of ANX-530 and Navelbine; the FDA's views on the
appropriateness of seeking marketing approval of ANX-530 under
Section 505(b)(2); 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; 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; 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; the risk that ADVENTRX
will be unable to raise sufficient capital to fund the projects
necessary to meet its anticipated or stated goals and milestones,
including funding the continued development of ANX-530; 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,
including as set forth in this press release, to reflect events or
circumstances arising after the date on which it was made.
DATASOURCE: ADVENTRX Pharmaceuticals CONTACT: Ioana C. Hone of
ADVENTRX Pharmaceuticals, +1-858-552-0866 Web site:
http://www.adventrx.com/
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