ADVENTRX Announces Positive Data From Preclinical Pharmacokinetic Testing of ANX-514 (Docetaxel Emulsion)
April 25 2007 - 7:00AM
PR Newswire (US)
Results Indicate Bioequivalent Pharmacokinetics With Reduced Risk
of Hypersensitivity Reactions With ANX-514 SAN DIEGO, April 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, today announced
positive results from preclinical pharmacokinetic testing of
ANX-514 (docetaxel emulsion) in a well recognized animal model. The
study results indicate bioequivalent pharmacokinetics between
ANX-514 and the FDA-approved version of docetaxel, marketed under
the brand name Taxotere(R). Furthermore, ANX-514, administered
intravenously, did not cause hypersensitivity reactions in this
study, as opposed to acute hypersensivity reactions observed
following intravenous treatment with Taxotere. ANX-514 is a novel
emulsion formulation of docetaxel, an agent for the treatment of
breast, non-small cell lung, prostate and gastric cancers. "These
preclinical results are important and strengthen our belief that
ANX-514 is an appropriate candidate for marketing approval under
the shorter timelines available under Section 505(b)(2)," said Evan
M. Levine, chief executive officer for ADVENTRX. "In addition,
these results suggest that treatment with ANX-514 may eliminate the
need for multi-day premedication with corticosteroids prior to
treatment, which is currently recommended prior to treatment with
Taxotere." In this study, docetaxel concentration in plasma was
sequentially measured over 24 hours following intravenous
injections with either ANX-514 or Taxotere. Pharmacokinetic
analysis indicated no statistically significant (p < 0.05)
differences in docetaxel maximum concentration (Cmax) or area under
the curve (AUC) between ANX-514 and Taxotere. In addition, less
toxicity was observed following dosing with ANX-514 than dosing
with Taxotere. Taxotere induced an anaphylactoid type reaction
consistent with hypersensitivity reactions, including acute
increases in blood histamine levels and decreased blood pressure.
In contrast, no hypersensitivity reactions, including no elevations
in histamine levels and no changes in blood pressure were observed
following dosing with ANX-514. ADVENTRX is continuing to conduct
additional preclinical pharmacokinetic testing of ANX-514 to
compare this product candidate with the approved version of the
product, marketed under the brand name Taxotere. The Company
currently plans to seek guidance from the FDA with respect to the
appropriateness of a Section 505(b)(2) NDA regulatory path for
ANX-514, and pending agreement on clinical protocol design with the
FDA, initiate a marketing-enabling clinical trial of ANX-514 in
2007. About ANX-514 (docetaxel emulsion) ANX-514 is a novel
nano-emulsion formulation of the chemotherapy drug docetaxel, a
product marketed under the brand name Taxotere. ANX-514 is designed
to eliminate the need for multi-day immunosuppressant
premedication. 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 allergic reactions. Docetaxel is approved
to treat breast, non-small cell lung, prostate, gastric and head
and neck cancers. In connection with a Section 505(b)(2) NDA
covering ANX-514, ADVENTRX must certify that all applicable
Taxotere patents have expired prior to the manufacture, use or sale
of ANX-514. 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. 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 preclinical and clinical results are not
indicative of the success of subsequent clinical trials and that
products will not perform as preclinical and clinical data suggests
or as otherwise anticipated; 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 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; 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;
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 assumes no obligation 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, Inc.
CONTACT: Investors, Ioana C. Hone of ADVENTRX Pharmaceuticals,
+1-858-552-0866; or Media, Amy Martini of WeissComm Partners,
+1-212-301-7223, for ADVENTRX Pharmaceuticals, Inc. Web site:
http://www.adventrx.com/ Company News On-Call:
http://www.prnewswire.com/comp/920134.html
Copyright
Adventrx (AMEX:ANX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Adventrx (AMEX:ANX)
Historical Stock Chart
From Jul 2023 to Jul 2024