ADVENTRX Grants Manufacturing Contract for ANX-514 (Docetaxel Emulsion)
April 05 2007 - 7:00AM
PR Newswire (US)
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. 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 Web site:
http://www.adventrx.com/ Company News On-Call:
http://www.prnewswire.com/gh/cnoc/comp/920134.html
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