Adventrx Announces CoFactor Phase 2b Clinical Trial Overall Survival Results
SAN DIEGO, June 16, 2008 /PRNewswire-FirstCall/ -- Adventrx Pharmaceuticals, Inc. today provided an update with regard to overall survival from its Phase 2b clinical trial of CoFactor for the treatment of first-line metastatic colorectal cancer. Overall survival results in this study have been revised upwards slightly, with the CoFactor/5-FU (5-fluorouracil) arm demonstrating a 14 day improvement in overall survival compared to the leucovorin/5-FU arm.
"In the Phase 2b study, CoFactor was dosed at 60mg/m2 by infusion to provide as unbiased a comparison as possible to leucovorin, which is administered at 200 mg/m2 by infusion over about 2 hours in this setting," stated Evan M. Levine, Chief Executive Officer and President of ADVENTRX. "Even while administering CoFactor over hours instead of the more optimal 2 to 3 minute bolus administration, and at a significantly lower dose of the folate, we were able to demonstrate a numerical advantage with respect to overall survival and progression-free survival with CoFactor plus 5-FU in this study, which is encouraging."
Consistent with its previous guidance, the Company anticipates announcing available interim data from its discontinued Phase 3 trial of CoFactor for the treatment of first line metastatic colorectal cancer later this month. Furthermore, the Company is on track to announce its decision about how to best move forward with its CoFactor program later this month.
About the CoFactor Phase 2b Study
The Phase 2b clinical trial was an international, open-label, randomized, controlled, multicenter study designed to evaluate the safety and efficacy of treatment with CoFactor/5-FU compared to leucovorin/5-FU utilizing an infusional administration in patients with first line metastatic colorectal cancer. Three hundred patients were randomized to receive CoFactor/5-FU or leucovorin/5- FU. The CoFactor/5-FU arm demonstrated comparable overall safety to the leucovorin/5-FU arm. However, the CoFactor/5-FU arm did not demonstrate statistically significant improved safety in the trial's primary endpoint, a reduction in the proportion of patients reporting at least one hematological or gastrointestinal adverse event of grade 3 or greater.
About ANX-510, or CoFactor
CoFactor is a folate-based biomodulator designed to replace leucovorin as the preferred method to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-FU (5-fluorouracil). Compared to leucovorin, CoFactor creates more stable binding between the active form of 5-FU and the target enzyme, thymidylate synthase. CoFactor bypasses the metabolic pathway required by leucovorin to deliver the active form of folate, potentially allowing 5-FU to work more effectively.
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 problems associated with these treatment regimens. More information can be found on ADVENTRX's web site at http://www.adventrx.com.
Forward Looking Statements
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 results of pending clinical trials for CoFactor; unexpected adverse side effects or inadequate therapeutic efficacy of CoFactor; the risk that preclinical and clinical 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; 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; the potential to attract a strategic partner and the terms of any related transaction; the potential for ADVENTRX's product candidates to receive regulatory approval for one or more indications on a timely basis or at all, and the uncertain process of seeking regulatory approval; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic 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.
CONTACT: investors, Ioana C. Hone of ADVENTRX Pharmaceuticals,+1-858-552-0866
Web site: http://www.adventrx.com/
Ticker Symbol: (AMEX:ANX)
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Posted: June 2008