SAN DIEGO, April 5 /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 that it has entered into
an agreement with Hyaluron Contract Manufacturing to manufacture ANX-514
(docetaxel emulsion) for preclinical and clinical studies.
"We are excited about the on-going development of ANX-514," said Evan
M. Levine, Chief Executive Officer of ADVENTRX. "ANX-514 fits well with our
approach of developing less toxic drugs and improving patient care. We
anticipate seeking guidance from the Food and Drug Administration with
regard to a 505(b)(2) regulatory path for ANX-514, and pending appropriate
clearances, initiating a marketing-enabling clinical trial of ANX-514 later
this year."
ADVENTRX is conducting preclinical pharmacokinetic testing of ANX-514
to compare this product candidate with the approved version of the product,
marketed under the brand name Taxotere(R). The Company currently plans to
seek guidance from the FDA in 2007 with respect to the appropriateness of a
Section 505(b)(2) NDA regulatory path for ANX-514.
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.
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. Section
505(b)(2) of the FDCA was enacted as part of the Drug Price Competition and
Patent Term Restoration Act of 1984, otherwise known as the Hatch-Waxman
Act. This procedure 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.
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. The Company's lead product
candidate, ANX-510 (CoFactor), is in Phase 3 and Phase 2b clinical trials
for the treatment of metastatic colorectal cancer, as well as in a Phase 2
clinical trial for the treatment of advanced breast cancer. More
information can be found on the Company's web site at
http://www.adventrx.com.
About Hyaluron Contract Manufacturing
Hyaluron Contract Manufacturing (HCM) is a leader in aseptic contract
manufacturing of filled liquid parenterals and medical devices. Since 1999,
HCM has been offering its customers-from newly established firms to
large-scale commercial enterprises-innovative and unique solutions to all
their aseptic formulation/fill needs. At the core of HCM's business is a
commitment to quality, regulatory compliance and on-time delivery as well
as courteous and professional communication. HCM is headquartered in
Burlington, MA. For further information, visit http://www.hyaluron.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. Such
forward-looking statements are made based on management's current
expectations and beliefs and should not be regarded as a statement or
representation by ADVENTRX that any of its plans, including its anticipated
milestones, will be achieved on time or at all. The potential risks and
uncertainties that could cause actual results to differ materially include,
but are not limited to: Hyaluron's ability to comply with current good
manufacturing practices or otherwise supply materials suitable for use in
human clinical trials; Hyaluron's ability to supply materials in quantities
and on timelines sufficient to meet ADVENTRX's needs; the FDA's views on
the appropriateness of ADVENTRX seeking marketing approval for ANX- 514
under Section 505(b)(2) of the FDCA; the ability of ADVENTRX to secure
meetings with the FDA on favorable timelines and the outcome of those
meetings; 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
ability to timely receive necessary regulatory approvals for ADVENTRX's
current and anticipated preclinical and clinical trials; 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; 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. All forward-looking
statements are qualified in their entirety by this cautionary statement and
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.
SOURCE ADVENTRX Pharmaceuticals, Inc.
 back to top
Related links:
http://www.adventrx.com
http://www.prnewswire.com/gh/cnoc/comp/920134.html/
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
|
