ADVENTRX Presents Results at 2007 AACR-NCI-EORTC International Conference
SAN DIEGO, Oct. 25 /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 it presented preclinical
results demonstrating that ANX-514, the company's docetaxel emulsion
product candidate, reduced hypersensitivity reactions without impacting
pharmacokinetics or antitumor activity when compared to Taxotere(R)
(docetaxel). The results were presented at the American Association of
Cancer Research (AACR), National Cancer Institute (NCI) and European
Organization and Treatment of Cancer (EORTC) International Conference
"Molecular Targets and Cancer Therapeutics" in San Francisco on October 25,
2007 by Mark J. Cantwell, Ph.D., vice president, research and development.
Docetaxel is an anti-cancer agent that is approved to treat breast,
non-small cell lung, prostate, gastric and head and neck cancers, and is
marketed under the brand name Taxotere(R). Annual sales of Taxotere in 2006
were approximately $2.2 billion.
"We feel the reduced hypersensitivity reactions associated with ANX-514
would be a benefit to patients and a way to differentiate ANX-514," stated
Evan M. Levine, chief executive officer of ADVENTRX. "We remain focused on
initiating a marketing-enabling clinical trial of ANX-514 later this year,
pending appropriate regulatory clearances."
In an established animal model, anaphylactoid clinical reactions were
observed following Taxotere administration, including decreased
respiration, swelling and tremors. Furthermore, decreases in blood pressure
and increases in histamine levels were observed within 10-20 minutes of
Taxotere administration. In contrast, hypersensitivity reactions were not
observed following administration of ANX-514; specifically, no
treatment-related change in blood pressure and no increase in histamine
levels were observed. In this crossover design study, even on re-challenge
at 3 weeks, hypersensitivity reactions were observed only in the Taxotere
treated animals. In two separate studies in different animal species,
ANX-514 showed bioequivalent pharmacokinetics to Taxotere. Moreover, in an
established in vivo model, ANX-514 demonstrated dose-dependent inhibition
of tumor growth with equivalent antitumor activity when compared to
Taxotere at equal dose levels.
A copy of the poster presentation is available for download from the
"Resources" section of the Company's web site at http://www.adventrx.com
under "Publications".
About ANX-514 (docetaxel emulsion)
ANX-514 is a novel nano-emulsion formulation of the chemotherapy drug
docetaxel, which is marketed under the brand name Taxotere. ANX-514 is
formulated without polysorbate 80 or other detergents and is intended to
reduce the severity and/or incidence of hypersensitivity reactions.
Docetaxel is an anti-cancer agent that acts by disrupting the cellular
microtubular network that is essential for cell division. Immunosuppressant
premedication is recommended for docetaxel therapy to reduce the incidence
and severity of hypersensitivity reactions. Docetaxel is approved to treat
breast, non-small cell lung, prostate, gastric and head and neck cancers.
ADVENTRX recently received confirmation from the U.S. Food and Drug
Administration (FDA) regarding its proposed 505(b)(2) New Drug Application
(NDA) regulatory plan for ANX-514. The FDA indicated that data from a
single study of approximately 28 patients that demonstrates the
bioequivalence of ANX-514 and Taxotere is sufficient clinical data to
support filing an NDA.
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 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 that preclinical results are not indicative of the
success of subsequent clinical trials and that products will not perform as
preclinical data suggests or as otherwise anticipated; 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-514; the FDA's views on the
appropriateness of seeking marketing approval of ANX-514 under Section
505(b)(2); difficulties or delays in developing, testing, manufacturing and
marketing and obtaining regulatory approval for ANX-514, including
receiving necessary regulatory approvals for clinical trials of ANX-514, in
a timely manner or at all, and the potential for automatic injunctions
regarding FDA approval of ANX-514 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 docetaxel; 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.
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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