Data Presented at American Association for Cancer Research Annual Meeting
SAN DIEGO, April 18 /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 positive results from
preclinical studies using a multidrug treatment regimen including ANX-510
(CoFactor(R)) at the American Association for Cancer Research (AACR) Annual
Meeting. Treatment with a regimen including CoFactor with 5-fluorouracil
(5-FU) and capecitabine (Xeloda(R)), an oral prodrug of 5-FU, demonstrated
superior inhibition of tumor growth and longer survival, with lower
systemic toxicity compared with treatment groups containing leucovorin or
capecitabine alone in a colorectal tumor model. An abstract entitled
"Antitumor activity and safety of a hybrid treatment regimen of
5,10-methylenetetrahydrofolate, 5-fluorouracil, and capecitabine in a
colorectal tumor xenograft model" was presented yesterday by the study's
lead author Mark Cantwell, Ph.D., the Company's vice president of research
and development.
"We believe CoFactor has the potential to improve fluoropyrimidine
chemotherapies and reduce toxicity in multiple treatment regimens," said
Evan M. Levine, ADVENTRX chief executive officer. "Based on these and other
data, we are continuing to evaluate various treatment combinations to
identify additional commercial opportunities and expand the value of
CoFactor."
Tumor-bearing mice treated with CoFactor, 5-FU and capecitabine had the
greatest inhibition of tumor growth compared to the other drug regimens
tested in this study, including capecitabine alone and a matched treatment
regimen of leucovorin (LV), 5-FU, and capecitabine. The mean tumor volume
of the CoFactor, 5-FU and capecitabine-treated mice (288.5 mm3 +/- 32.6,
mean +/- SEM) was statistically significantly less (p < 0.05) than mice
treated with either capecitabine alone (461.0 mm3 +/- 50.4) or mice treated
with LV, 5-FU and capecitabine (447.8 mm3 +/- 46.5). Consistent with
superior inhibition of tumor growth, treatment with CoFactor, 5-FU and
capecitabine also prolonged survival compared to the other treatment
regimens. The median survival of CoFactor, 5-FU and capecitabine treated
mice (60 days) was statistically significantly longer (p < 0.05) than
capecitabine alone (38 days) and LV, 5-FU and capecitabine (39 days).
Importantly, the increased tumor inhibition and survival benefits of
treatment with CoFactor, 5-FU and capecitabine did not come at the cost of
added toxicity. Treatment with CoFactor, 5-FU and capecitabine caused less
severe weight loss than all other drug treatments, including capecitabine
alone. These results suggest a hybrid treatment regimen, consisting of a
CoFactor and 5-FU treatment backbone coupled with capecitabine, might
confer improvements in antitumor activity and survival without
corresponding increases in systemic toxicity in patients with colorectal
cancer. The Company plans to pursue further testing of this CoFactor
treatment regimen.
About CoFactor
CoFactor (ANX-510) is a folate-based biomodulator drug designed to
replace leucovorin as the preferred method to enhance the activity and
reduce associated toxicity of the widely used cancer chemotherapy
5-fluorouracil (5-FU). In comparison to leucovorin, CoFactor creates more
stable binding of the active form of 5-FU to the target enzyme, thymidylate
synthase (TS). CoFactor bypasses the metabolic pathway required by
leucovorin to deliver the active form of folate, allowing 5-FU to work more
effectively. 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.
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. More information can be found
on the Company'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, 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. The potential
risks and uncertainties that could cause actual results for our CoFactor
studies to differ materially include, but are not limited to: the validity
of research results; unexpected adverse side effects or inadequate
therapeutic efficacy of CoFactor(R) or Adventrx's other product candidates;
the risk that preclinical 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;
uncertainties inherent in the drug development process; the timing and
success of clinical trials; the receipt of necessary approvals from the FDA
and other regulatory agencies; 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. ADVENTRX
does not intend to 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.
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Related links: http://www.adventrx.com
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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 Pharmaceuticals
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