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.
SOURCE ADVENTRX Pharmaceuticals, Inc.
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Related links:
http://www.adventrx.com
CONTACT:
investors, Ioana C. Hone of ADVENTRX
Pharmaceuticals, Inc., +1-858-552-0866
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