ADVENTRX Awards Manufacturing Contract for ANX-201 (Thiovir(TM))
March 20 2007 - 7:00AM
PR Newswire (US)
SAN DIEGO, March 20 /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
Pharmatek Laboratories, a pharmaceutical chemistry development
organization, for the manufacturing of ANX-201 (Thiovir) capsules
for clinical studies. "Pharmatek is an experienced contract
manufacturer and we are confident in their ability to produce
reliable cGMP material for our clinical trials," said Michele
Yelmene, vice president of regulatory affairs. "The drug supply
they generate under this contract is expected to provide the
Company with inventory for our Phase 1/2 study in HIV, which we
anticipate initiating later this year." ADVENTRX plans to file an
investigational new drug application (IND) with the US Food and
Drug Administration (FDA) in the second quarter of 2007, and
pending appropriate clearances, to initiate in the third quarter of
2007 a Phase 1/2 clinical trial of ANX-201 as a component of
multi-drug therapy for the treatment of HIV. About ANX-201
(Thiovir) ANX-201 is a member of a new class of reverse
transcriptase inhibitor (RTI) designed for oral delivery as a
component of AZT-based highly active antiretroviral therapy.
ANX-201 is a pyrophosphate analog which delivers both
thiophosphonoformate (TPFA) and phosphonoformate (PFA, foscarnet).
The HIV resistance profile of ANX-201 and foscarnet is unique among
RTIs reflecting the distinct mechanism of action of this novel drug
class. 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 Pharmatek
Laboratories, Inc. Pharmatek Laboratories Inc. is a pharmaceutical
chemistry development company providing full-service product
development for the pharmaceutical industry. Pharmatek focuses on
bringing client compounds from discovery to the clinic with
services that include compound selection, analytical development,
preformulation testing, formulation development, GMP manufacturing,
and stability storage and testing. More information can be found on
the company's web site at http://www.pharmatek.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: Pharmatek's ability to comply with
current good manufacturing practices or otherwise supply materials
suitable for use in human clinical trials; Pharmatek's ability to
supply materials in quantities and on timelines sufficient to meet
ADVENTRX's needs; 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-201; the ability to timely receive
necessary regulatory approvals for ADVENTRX's current and
anticipated clinical trials, including the currently planned Phase
1/2 clinical trial of ANX-201; 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, Inc., +1-858-552-0866; or Media, Amy Martini of
WeissComm Partners, +1-212-301-7223, for ADVENTRX Pharmaceuticals,
Inc. Web site: http://www.pharmatek.com/ Web site:
http://www.adventrx.com/ Company News On-Call:
http://www.prnewswire.com/gh/cnoc/comp/920134.html
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