ANX-201 Demonstrates a Unique Resistance Profile in Preclinical Tests
March 31 2008 - 6:00AM
PR Newswire (US)
ADVENTRX Presents Results at Keystone Symposia HIV Pathogenesis
Conference SAN DIEGO, March 31 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (AMEX:ANX) announced that it presented
preclinical results for ANX-201, the Company's broad-spectrum
antiviral product candidate at the Keystone Symposia HIV
Pathogenesis Conference in Banff, Alberta on March 30, 2008. The
preclinical results demonstrate a unique resistance profile for
ANX-201 and suggest suppression of resistance to nucleoside reverse
transcriptase inhibitors (NRTIs), a commonly used class of drugs to
treat HIV. The HIV Pathogenesis Conference is part of the Keystone
Symposia Global Health Series, which is supported by the Bill &
Melinda Gates Foundation. The poster presentation entitled "The
pyrophosphate analogue thiophosphonoformic acid confers a favorable
HIV resistance profile," was presented by Shani Waninger, Ph.D.,
associate director for research and development at ADVENTRX.
ANX-201 (thiophosphonoformic acid) is a pyrophosphate analog and
member of a new class of reverse transcriptase inhibitor (RTI) that
is being developed to provide benefits for treatment-resistant
HIV-infected patients. Foscarnet, the main metabolite of ANX-201,
is approved by the FDA for use in immunocompromised patients with
CMV retinitis and mucocutaneous acyclovir-resistant HSV infections.
However, clinical use of foscarnet is limited, in part due to its
intravenous administration and low oral bioavailability. In
contrast, in vivo tests have demonstrated increased oral
bioavailability of ANX-201, relative to foscarnet, potentially
enabling oral delivery. The preclinical data presented at the
conference show that virus selected for resistance to ANX-201
develop genetic mutations, some previously described for
foscarnet-resistant virus, as well as unique genetic mutations not
previously linked to foscarnet or foscarnet derivatives. Regardless
of the specific mutations, the preclinical studies show that
ANX-201-resistant virus was sensitive, and in most cases
hypersusceptible, to multiple NRTIs and non-nucleoside reverse
transcriptase inhibitors (NNRTIs). The nature of the resistance
mutations suggest that, if patients develop resistance to ANX-201,
they may be resensitized and made hypersusceptible to NRTIs or
NNRTIs. The preclinical studies also show that virus coresistant to
ANX-201 and NRTI could not be generated, which supports the
mutually exclusive resistance mechanism of these two drug classes.
This suggests that patients treated with ANX-201 combined with
NRTIs may be less likely to develop, or have a delay in development
of, treatment-resistance. Activity of ANX-201 was also examined
using the PhenoSense(R) assay against a panel of clinical isolates
containing viruses that had developed varying degrees of resistance
to NRTIs and/or NNRTIs. All clinical isolates tested were sensitive
to ANX-201, the majority being hypersusceptible. This suggests that
patients infected with viruses that are NRTI- or NNRTI-resistant
may be hypersusceptible to ANX-201. Clinical studies have shown
that hypersusceptibility to HIV drugs is a significant predictor of
the magnitude of HIV reduction and increase in CD4 T cells in
patients who have failed one or more previous antiretroviral
regimens. About ANX-201 ANX-201 (thiophosphonoformic acid) is a
pyrophosphate analog and member of a new class of reverse
transcriptase inhibitor (RTI) that is being developed to provide
benefits for treatment-resistant HIV-infected patients. The
resistance profile of ANX-201 is unique among approved RTIs and has
been shown to resensitize NRTI-resistant viruses. In preclinical
studies, ANX-201 has shown activity against treatment-resistant
clinical isolates and demonstrated synergistic activity with NRTIs,
suggesting potential clinical benefits of combination therapy. In
other preclinical studies, ANX-201 has shown broad-spectrum
antiviral activity against HIV-1, HIV-2, human and avian influenza
viruses, and herpes simplex viruses 1 and 2 (HSV-1 and HSV-2).
About ADVENTRX Pharmaceuticals ADVENTRX Pharmaceuticals is a
biopharmaceutical company focused on in-licensing, developing and
commercializing proprietary product candidates primarily for the
treatment of cancer and infectious disease. The Company seeks to
improve the performance and commercial potential of existing
treatments by addressing limitations associated with these
treatment regimens. More information can be found on ADVENTRX'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
validity of research results; 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; unexpected adverse side effects or
inadequate therapeutic efficacy of ADVENTRX's product candidates
and other uncertainties inherent in the drug development process;
the timing and success of clinical trials; difficulties or delays
in developing, testing, manufacturing, and obtaining regulatory
approval for ADVENTRX's product candidates; 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;
and other risks and uncertainties more fully described in
ADVENTRX's press releases and public 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 update any
forward-looking statement 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 Web site: http://www.adventrx.com/
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