SAN DIEGO, Dec. 5 /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, announced today that it has completed
patient enrollment in its Phase 2 clinical trial of ANX-510, or CoFactor,
for the treatment of advanced breast cancer.
"Data on the primary endpoint in this study, along with overall
survival data from our Phase 2b study and available data from our
discontinued Phase 3 study, all of which we expect in the second quarter of
2008, will expand our understanding of CoFactor's safety and efficacy,"
said Evan M. Levine, chief executive officer of ADVENTRX. "By mid-next year
we should have greater insight into our ability to develop CoFactor in
breast cancer and other indications."
The Phase 2 clinical trial is a single arm, multicenter study to
evaluate the safety and efficacy of treatment with CoFactor plus
5-fluorouracil (5-FU) in advanced breast cancer patients who have failed
anthracycline and taxane chemotherapies. Patients are treated with CoFactor
followed by 5-FU administered by IV bolus weekly for 6 weeks, with tumor
and safety assessments every 8 weeks. The primary endpoint for the study is
objective response rate as defined by Response Evaluation Criteria in Solid
Tumors (RECIST) criteria, and secondary endpoints are duration of response,
progression free survival, overall survival and incidence and severity of
adverse events, as defined by the National Cancer Institute (NCI) Common
Terminology Criteria. A total of 32 patients were enrolled in this study.
According to the American Cancer Society, breast cancer is the most
frequently diagnosed cancer in American women and the second leading cause
of cancer-related deaths in women after lung cancer. Over 214,000 new cases
of breast cancer and over 41,000 deaths from breast cancer are expected in
the U.S. in 2006. Despite advances made in treatment options that have led
to a significant increase in survival and quality of life, metastatic
disease is still incurable. Five-year survival rates decrease with
advancing disease stage: from 98% in localized disease to 80% with regional
spreading to only 26% with metastatic disease.
About ANX-510, or CoFactor
CoFactor 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 chemotherapeutic agent 5-FU.
Compared 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, potentially allowing 5-FU to work more effectively.
In October 2007, ADVENTRX announced the results from its Phase 2b
clinical trial of CoFactor for the treatment of metastatic colorectal
cancer. 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. Further analysis of
the Phase 2b study, in which 5-FU was administered by infusion, has
uncovered no significant differences between the study arms with regard to
either efficacy or safety. In November 2007, ADVENTRX announced that it
would discontinue enrolling patients in its Phase 3 clinical trial of
CoFactor for the first-line treatment of metastatic colorectal 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 and
bioavailability, excessive toxicity and treatment resistance. 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 risk that ADVENTRX will be unable to partner its
product candidates and the terms of any related transaction; the results of
pending clinical trials; 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;
difficulties or delays in developing, testing, manufacturing and marketing
of and obtaining regulatory approval for ADVENTRX's product candidates; the
market potential for ADVENTRX's product candidates and ADVENTRX's and any
future partners' ability to compete in those markets; unexpected adverse
side effects or inadequate therapeutic efficacy of ADVENTRX's product
candidates that could delay or prevent regulatory approval or
commercialization, or that could result in recalls or product liability
claims; 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; 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.
SOURCE ADVENTRX Pharmaceuticals, Inc.
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Related links:
http://www.adventrx.com
CONTACT:
Ioana C. Hone of ADVENTRX Pharmaceuticals,
+1-858-552-0866
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