ADVENTRX Presents CoFactor Data at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO)
June 03 2008 - 7:00AM
PR Newswire (US)
SAN DIEGO, June 3 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (AMEX:ANX) announced today that it presented
objective response rate and available safety data from the
Company's Phase 2 clinical study of ANX-510, or CoFactor(R), for
the treatment of advanced breast cancer at the 2008 American
Society of Clinical Oncology (ASCO) Annual Meeting, which takes
place May 30 - June 3, 2008 in Chicago, IL. CoFactor plus 5-FU
(5-Fluorouracil) was determined to be a safe, well-tolerated and
active treatment regimen in advanced breast cancer patients who are
Herceptin receptor (Her2/neu) negative and who have failed prior
taxane and anthracycline therapies. Data available from 31 patients
indicated a 23% objective response rate with CoFactor plus 5-FU
based on investigators' assessments. Objective response rate was
based on the number of complete responses and partial responses
observed in this study. The poster presentation, entitled "5,10
methylenetetrahydrofolic acid with 5-fluorouracil as treatment for
advanced breast cancer in patients who failed prior treatment with
anthracyclines and taxanes: A phase 2 study," was presented by Dr.
Joachim P.H. Schupp, Vice President of Medical Affairs on June 2,
2008. Historically, capecitabine (Xeloda(R)), a widely-used
treatment for advanced breast cancer, has demonstrated response
rates between 14% and 26% when studied as monotherapy in patients
with advanced breast cancer who failed prior treatment with
anthracyclines and taxanes. In this well-defined study population,
two recently published, Phase 3 clinical trials, where capecitabine
was the approved therapy, demonstrated response rates of 14% for
capecitabine alone compared with 35% for capecitabine in
combination with ixabepilone or 22% for capecitabine in combination
with lapatinib. "This CoFactor data is encouraging to us as it
surpasses the most recently reported response rates with
capecitabine in pretreated advanced breast cancer patients.
CoFactor plus 5-FU could be an effective and safe treatment option
for patients with pretreated advanced breast cancer with the
potential for further improvements to be shown with appropriate
combination therapies," stated Evan M. Levine, Chief Executive
Officer and President of ADVENTRX. "We look forward to evaluating
all of the available data from the rest of our CoFactor program,
and following analysis of these data we should have greater insight
into the value of continuing to develop CoFactor," added Mr.
Levine. The most common adverse events in this study were expected
and included the following, which reflects all grades: asthenia
(52%), nausea (33%), diarrhea (29%), vomiting (26%), anorexia
(23%), dyspnea (23%), and neutropenia (23%). Five patients reported
12 serious adverse events (pneumonia, abdominal pain, diarrhea (2),
general physical health deterioration (3), pancytopenia, breast
pain, dyspnea, asthenia, and hypersensitivity). Patients in this
study will continue to be followed for other efficacy and safety
parameters. The Company's Phase 2 clinical trial was a single arm,
multicenter study designed to evaluate the safety and efficacy of
treatment with CoFactor/5-FU utilizing a bolus administration in
patients with advanced breast cancer who have failed anthracycline
and taxane chemotherapies with clearly defined criteria. The
primary endpoint for the study is assessing objective response rate
as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
criteria. RECIST criteria is a series of formalized rules for the
measurement of tumor target lesions and involves techniques which
measure tumor response using X-rays, CT and MRI scans. Objective
response rate is measured by combining the number of complete
responses and partial responses. According to RECIST criteria, a
complete response (CR) indicates the disappearance of all target
lesions and a partial response (PR) indicates a 30% decrease in the
sum of the longest diameter of target lesions. A total of 32
patients were enrolled in this study and 31 patients received at
least one dose of drug. A treatment cycle consisted of 60 mg/m2 of
CoFactor plus 500 mg/m2 of 5-FU, weekly i.v. (intra-venous) for a
period of 6 weeks, repeated every 8 weeks. CoFactor was
administered at a dose of 60 mg/m2 as an i.v. bolus over 2-3
minutes. Administration of CoFactor was followed 20 minutes later
by 500 mg/m2 of 5-FU as an i.v. bolus over 2-3 minutes. 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 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; 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. DATASOURCE: ADVENTRX Pharmaceuticals, Inc. CONTACT:
investors, Ioana C. Hone of ADVENTRX Pharmaceuticals, Inc.,
+1-858-552-0866 Web site: http://www.adventrx.com/
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