ADVENTRX Presents Positive ANX-530 Preclinical Results
April 05 2006 - 9:00AM
PR Newswire (US)
SAN DIEGO, April 5 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (AMEX:ANX) announced today that it presented
preclinical study results showing an improved toxicity profile for
its oncology compound, ANX-530 (vinorelbine emulsion), an emulsion
formulation of the FDA-approved drug vinorelbine tartrate. The
study results suggest lower venous toxicity of the emulsion
formulation compared to the FDA-approved drug, vinorelbine
solution, while maintaining similar antitumor activity and
pharmacokinetics. The presentation, entitled "A novel emulsion
formulation of vinorelbine attenuates venous toxicity while
maintaining antitumor efficacy" was presented at the American
Association for Cancer Research (AACR) 97th Annual Meeting 2006 on
Wednesday, April 5 by Mark J. Cantwell, Ph.D., vice president of
research and development for ADVENTRX. ANX-530 is a new formulation
of vinorelbine that is designed to protect the venous endothelium
during administration, therefore reducing vein irritation, a common
side-effect seen with the approved drug. Vein toxicity, edema and
erythema were examined in rabbits following repeated intravenous
(IV) injections in the marginal ear vein. For all toxicity
parameters tested, animals dosed with ANX-530 showed less toxicity
than those dosed with vinorelbine solution. In addition, while all
animals in the ANX-530 groups received the full set of repeated
injections, animals in the vinorelbine solution group did not
receive all the planned injections due to the severity of toxicity.
Moreover, tissue distribution following drug administration was
assessed and showed significantly less drug accumulation in brain
tissue in the ANX-530 group compared with the vinorelbine solution
group, suggesting the potential for lower neurotoxicity. Despite
the toxicity differences, drug pharmacokinetics in rodent plasma,
and antitumor activity in animals transplanted with human lung and
breast tumor xenografts, was similar for both drugs. Copies of the
poster presentation are available in the "Resources" section of the
Company's Web site at
http://www.adventrx.com/library/publications.htm. "These
preclinical findings for ANX-530 are encouraging since vein
irritation is an important factor in patient comfort. If similar
results are shown clinically, we believe there is potential for
more widespread use of this active chemotherapy," said Joan M.
Robbins, Ph.D., ADVENTRX chief scientific officer and executive
vice president. "We intend to study vein irritation in the clinic
during the bioequivalency trial with ANX-530 which is planned to
begin in the fourth quarter of this year." About ANX-530 ANX-530 is
a novel emulsion formulation of vinorelbine tartrate. Vinorelbine
is a chemotherapeutic agent indicated as a single agent or in
combination with cisplatin for treatment of advanced non-small cell
lung cancer (NSCLC). The Company plans to conduct a single
bioequivalency study of ANX-530 as a marketing-enabling clinical
trial, a plan that was recently affirmed by the FDA. The Company
currently plans to file an IND application in the third quarter of
2006. The proposed clinical trial will compare the bioequivalency
of ANX-530 with that of vinorelbine in patients with advanced solid
tumors. In addition, the Company plans to collect comparative data
on vein irritation and other safety parameters as secondary
endpoints. About ADVENTRX ADVENTRX Pharmaceuticals is a
biopharmaceutical research and development company focused on
introducing new technologies for anticancer and antiviral
treatments that surpass the performance and safety of existing
drugs, by addressing significant problems such as drug metabolism,
toxicity, bioavailability and resistance. More information can be
found on the Company's Web site at http://www.adventrx.com/.
Forward Looking Statement This press release contains
forward-looking statements, within the meaning of the "safe harbor"
provisions of the Private Securities Litigation Reform Act of 1995,
regarding ADVENTRX. Such statements are made based on management's
current expectations and beliefs. Actual results may vary from
those currently anticipated based upon a number of factors,
including uncertainties inherent in the drug development process,
the timing and success of clinical trials, the validity of research
results, and the receipt of necessary approvals from the FDA and
other regulatory agencies. For a discussion of such risks and
uncertainties, which could cause actual results to differ from
those contained in the forward-looking statements regarding
ADVENTRX, see the section titled "Risk Factors" in ADVENTRX's last
annual report on Form 10-K, as well as other reports that ADVENTRX
files from time to time with the Securities and Exchange
Commission. All forward-looking statements regarding ADVENTRX are
qualified in their entirety by this cautionary statement. ADVENTRX
undertakes no obligation to release publicly any revisions, which
may be made to reflect events or circumstances after the date
hereof. DATASOURCE: ADVENTRX Pharmaceuticals CONTACT: Andrea Lynn
of ADVENTRX Pharmaceuticals, +1-858-552-0866 Web site:
http://www.adventrx.com/library/publications.htm Web site:
http://www.adventrx.com/ Company News On-Call:
http://www.prnewswire.com/gh/cnoc/comp/920134.html
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