SAN DIEGO, April 18, 2007 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. , 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 statistical ly 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.
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 www.sec.gov. ADVENTRX does not intend to update any forward-looking st atement, including as set forth in this press release, to reflect events or circumstances arising after the date on which it was made.
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/
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Ticker Symbol: (AMEX:ANX)
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