ADVENTRX Initiates CoFactor Phase II Clinical Trial in Refractory Breast Cancer
December 27 2006 - 6:00AM
PR Newswire (US)
SAN DIEGO, Dec. 27 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (AMEX:ANX) today announced the initiation of
a Phase II clinical trial using CoFactor(R) in the treatment of
refractory metastatic breast cancer. CoFactor (ANX-510) is a
folate-based biomodulator drug designed to enhance the activity and
reduce associated toxicity of the widely used cancer
chemotherapeutic agent 5-fluorouracil (5-FU). This study builds on
the results of earlier studies and will more fully investigate the
efficacy and safety of CoFactor for patients with previously
treated, advanced breast cancer. "The initiation of this Phase II
clinical trial for CoFactor represents an important milestone in
the global registration strategy for our lead product development
program," said Evan M. Levine, chief executive officer of ADVENTRX.
"We are enthusiastic about CoFactor's potential to enhance the
efficacy and safety of 5-FU chemotherapy in the treatment of
refractory breast cancer." "We are pleased to have launched this
study of CoFactor in combination with 5-FU in advanced breast
cancer," added James A. Merritt, MD, president and chief medical
officer of ADVENTRX. "The CoFactor and 5-FU regimen has
demonstrated activity in multiple tumor types, including breast in
a Phase I clinical trial, and we have safety data from other
CoFactor studies in metastatic colorectal cancer that suggest
CoFactor is well-tolerated. We believe a CoFactor plus 5-FU regimen
could offer a worthwhile alternative in the overall management of
breast cancer." This Phase II clinical trial is a single arm,
multicenter study to evaluate the safety and efficacy of treatment
with CoFactor plus 5-FU in advanced breast cancer patients who have
failed anthracycline and taxane chemotherapies. Patients will be
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 (RECIST criteria), and secondary endpoints are duration of
response, progression free survival, overall survival and incidence
and severity of adverse events (AEs), as defined by the NCI Common
Terminology Criteria. A total of 31 patients are expected to be
enrolled at 6 clinical sites. 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 US 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 CoFactor CoFactor (ANX-510) is a folate-based
biomodulator drug designed to replace leucovorin 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
chemical pathway required by leucovorin to deliver the active form
of folate, allowing 5-FU to work more effectively. In addition to
the Phase II breast cancer trial, CoFactor is being studied in
first-line treatment of metastatic colorectal cancer in a Phase IIb
and pivotal Phase III clinical trial. About ADVENTRX
Pharmaceuticals ADVENTRX Pharmaceuticals is a biopharmaceutical
research and development company focused on commercializing low
development risk pharmaceuticals for cancer and infectious disease
that enhance the efficacy and/or safety of existing therapies. More
information can be found on ADVENTRX'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. Such forward-looking statements are made based on
management's current expectations and beliefs and should not be
regarded as a statement or representation by ADVENTRX that any of
its plans, including its anticipated milestones, will be achieved
on time or at all. The potential risks and uncertainties that could
cause actual results to differ materially include, but are not
limited to: 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 ability to timely enroll subjects in ADVENTRX's
current and anticipated clinical trials; the results of pending
clinical trials for CoFactor(R) or ADVENTRX's other product
candidates; the potential for CoFactor(R) and ADVENTRX's other
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; other difficulties or delays in
developing, testing, manufacturing and marketing of and obtaining
regulatory approval for CoFactor(R) or ADVENTRX's other product
candidates; the market potential for fluoropyrimidine biomodulators
and other target markets, and ADVENTRX's ability to compete in
those markets; unexpected adverse side effects or inadequate
therapeutic efficacy of CoFactor(R) or ADVENTRX's other products
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 potential for regulatory
authorities to require additional preclinical work or other
clinical requirements to support regulatory filings; the scope and
validity of patent protection for CoFactor(R) and Adventrx' other
product candidates; 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. All forward-looking statements are qualified in
their entirety by this cautionary statement and ADVENTRX assumes no
obligation to revise or update any forward-looking statement,
including as 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: Ioana C. Hone
of ADVENTRX Pharmaceuticals, Inc., +1-858-552-0866 Web site:
http://www.adventrx.com/ Company News On-Call:
http://www.prnewswire.com/comp/920134.html
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