Cooperative Research and Development Agreement Establishes Framework for
Participation of VA Hospitals and Clinics in Phase 3 Study of ANX-510
(CoFactor)
SAN DIEGO, May 24 /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, today announced that it has finalized a
Clinical Trial Cooperative Research and Development Agreement (CRADA) under
which U.S. Department of Veterans Affairs (VA) clinical sites may
participate in the Company's Phase 3 clinical trial of ANX-510 (CoFactor)
for the treatment of metastatic colorectal cancer. To date, under this
arrangement, the Company has executed clinical trial agreements with three
regional VA centers.
"The participation of the VA and its broad network of hospitals and
clinics expands our ability to reach patients with metastatic colorectal
cancer and should accelerate enrollment in our Phase 3 clinical trial of
CoFactor," said Evan M. Levine, chief executive officer of ADVENTRX. "Over
the next several months, we expect to enter into agreements with additional
VA sites and look forward to advancing our CoFactor Phase 3 clinical
trial."
About the Phase 3 Clinical Trial of ANX-510 (CoFactor)
ADVENTRX is conducting a Phase 3 clinical study of ANX-510 for the
treatment of metastatic colorectal cancer. This 1,200 patient, randomized
clinical trial is being conducted in as many as 100 sites across the U.S.
and in additional sites overseas. Patients are randomized to two arms
containing either CoFactor or leucovorin, each in combination with the
widely used cancer chemotherapy agent 5-fluorouracil (5-FU) and bevacizumab
(Avastin(R)). The primary endpoint for the study is progression-free
survival. Secondary endpoints include response rate, overall survival and
incidence and severity of adverse events. The protocol and planned analysis
were accepted by the FDA under a Special Protocol Assessment.
About ANX-510 (CoFactor)
ANX-510 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 chemotherapy 5-fluorouracil
(5-FU). In comparison to leucovorin, ANX-510 creates more stable binding of
the active form of 5-FU to the target enzyme, thymidylate synthase (TS).
ANX-510 bypasses the metabolic pathway required by leucovorin to deliver
the active form of folate, allowing 5-FU to work more effectively. ANX-510
is in Phase 3 and Phase 2b clinical trials for the treatment of metastatic
colorectal cancer, as well as in a Phase 2 clinical trial for the treatment
of advanced breast 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, bioavailability,
excessive toxicity and treatment resistance. More information can be found
on the Company'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. These risks and
uncertainties 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, including those
associated with the development of CoFactor; the ability to timely enroll
subjects in ADVENTRX's current and anticipated clinical trials; the timing
and success of clinical trials, including its Phase 3 clinical trial of
CoFactor; adverse side effects or inadequate therapeutic efficacy of
CoFactor; the risk that preclinical 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 potential
for CoFactor 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 CoFactor; the scope and validity of patent
protection for CoFactor; 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 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.
SOURCE ADVENTRX Pharmaceuticals, Inc.
 back to top
Related links:
http://www.adventrx.com
http://www.prnewswire.com/comp/920134.html /
CONTACT:
Investors, Ioana C. Hone of ADVENTRX
Pharmaceuticals, Inc., +1-858-552-0866; or Media, Edie DeVine of
WeissComm Partners, +1-415-946-1081, for ADVENTRX
Pharmaceuticals, Inc.
|
