ADVENTRX Announces Positive Data From Multidrug Therapy With CoFactor
April 18 2007 - 7:00AM
PR Newswire (US)
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. 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 Pharmaceuticals Web site:
http://www.adventrx.com/ Company News On-Call:
http://www.prnewswire.com/comp/920134.html
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