ANX-530 Demonstrates Statistically Significant Reduction in Injection Site
Reactions
SAN DIEGO, Jan. 14 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals,
Inc. (Amex: ANX) today announced safety results from its marketing-enabling
bioequivalence clinical study of ANX-530 (vinorelbine emulsion). ANX-530
demonstrated a statistically significant reduction in injection site
reactions when compared to Navelbine(R) (p<0.05). The incidence of
injection site reactions attributed to Navelbine was consistent with its
product label. Furthermore, ANX-530 was determined to be safe and
well-tolerated with no significant differences observed in any other safety
parameters. In November 2007, ADVENTRX announced that it met the primary
endpoint in this study, with pharmacokinetic equivalence observed between
ANX-530 and Navelbine. Full results from this study have been submitted for
presentation at an upcoming oncology conference.
ADVENTRX also announced that it 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. In December 2007, ADVENTRX met
with the FDA to discuss its commercial manufacturing plans for ANX-530. The
Company reached agreement with the FDA regarding commercial manufacturing
requirements for ANX-530, as well as requisites for the Chemistry
Manufacturing and Controls (CMC) section of the NDA. As a follow up,
ADVENTRX anticipates holding a pre-NDA meeting with the FDA in the second
quarter of 2008.
"We are extremely encouraged by these data, and pleased that our goal
to improve the safety of vinorelbine was observed in the clinic.
Particularly compelling is that even in a small study we were able to
observe a statistical difference in injection site reactions," stated Evan
M. Levine, chief executive officer of ADVENTRX. "We are excited by the
continued progress of ANX-530 and look forward to our NDA submission later
this year."
ANX-530 is a novel emulsion formulation of vinorelbine. Vinorelbine,
marketed under the brand name Navelbine and available in generic versions,
is an anti-cancer agent approved to treat advanced non-small cell lung
cancer as a single agent or in combination with cisplatin. Worldwide sales
of Navelbine and generic vinorelbine in 2006 were in excess of $200
million.
The bioequivalence study of ANX-530 was an open-label crossover
comparison of ANX-530 and Navelbine in 31 patients, with a primary
objective of demonstrating the pharmacokinetic equivalence of ANX-530 and
Navelbine. Determining the safety of a single dose of ANX-530 was a
secondary objective. In the first week, patients were dosed with either
ANX-530 or Navelbine, and after a washout period, were dosed with the
opposite drug during the second week of treatment. The FDA has indicated
that this single clinical study, should it demonstrate pharmacokinetic
equivalence between ANX-530 and Navelbine, would provide sufficient
clinical data to support a Section 505(b)(2) NDA.
Adverse events in the study were analyzed by logistic regression models
with factors for treatment (ANX-530 vs. Navelbine), phase (days 1-7 vs.
days 8-14), sequence (ANX-530 followed by Navelbine vs. Navelbine followed
by ANX-530) and subject within a sequence. The most common adverse events
were neutropenia, leucopenia, injection site phlebitis, and constipation.
Injection site reactions were the only adverse events that were
statistically different between the control arm and the study arm.
About ANX-530 (vinorelbine emulsion)
ANX-530 is designed to reduce the incidence and severity of injection
site reaction 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 Section 505(b)(2)
Section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act (FDCA) allows
the 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 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.
SOURCE ADVENTRX Pharmaceuticals, Inc.
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Related links:
http://www.adventrx.com
CONTACT:
Ioana C. Hone of ADVENTRX Pharmaceuticals,
Inc., +1-858-552-0866
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